Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma
Identifieur interne : 001957 ( Pmc/Checkpoint ); précédent : 001956; suivant : 001958Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma
Auteurs : Antoni Ribas ; Richard Kefford ; Margaret A. Marshall ; Cornelis J. A. Punt ; John B. Haanen ; Maribel Marmol ; Claus Garbe ; Helen Gogas ; Jacob Schachter ; Gerald Linette ; Paul Lorigan ; Kari L. Kendra ; Michele Maio ; Uwe Trefzer ; Michael Smylie ; Grant A. Mcarthur ; Brigitte Dreno ; Paul D. Nathan ; Jacek Mackiewicz ; John M. Kirkwood ; Jesus Gomez-Navarro ; Bo Huang ; Dmitri Pavlov ; Axel HauschildSource :
- Journal of Clinical Oncology [ 0732-183X ] ; 2013.
Abstract
In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy.
Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine).
In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88;
This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.
Url:
DOI: 10.1200/JCO.2012.44.6112
PubMed: 23295794
PubMed Central: 4878048
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma</title><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Marshall, Margaret A" sort="Marshall, Margaret A" uniqKey="Marshall M" first="Margaret A." last="Marshall">Margaret A. Marshall</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Punt, Cornelis J A" sort="Punt, Cornelis J A" uniqKey="Punt C" first="Cornelis J. A." last="Punt">Cornelis J. A. Punt</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Haanen, John B" sort="Haanen, John B" uniqKey="Haanen J" first="John B." last="Haanen">John B. Haanen</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Marmol, Maribel" sort="Marmol, Maribel" uniqKey="Marmol M" first="Maribel" last="Marmol">Maribel Marmol</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Schachter, Jacob" sort="Schachter, Jacob" uniqKey="Schachter J" first="Jacob" last="Schachter">Jacob Schachter</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Linette, Gerald" sort="Linette, Gerald" uniqKey="Linette G" first="Gerald" last="Linette">Gerald Linette</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Kendra, Kari L" sort="Kendra, Kari L" uniqKey="Kendra K" first="Kari L." last="Kendra">Kari L. Kendra</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Smylie, Michael" sort="Smylie, Michael" uniqKey="Smylie M" first="Michael" last="Smylie">Michael Smylie</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dreno">Brigitte Dreno</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Nathan, Paul D" sort="Nathan, Paul D" uniqKey="Nathan P" first="Paul D." last="Nathan">Paul D. Nathan</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Mackiewicz, Jacek" sort="Mackiewicz, Jacek" uniqKey="Mackiewicz J" first="Jacek" last="Mackiewicz">Jacek Mackiewicz</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Gomez Navarro, Jesus" sort="Gomez Navarro, Jesus" uniqKey="Gomez Navarro J" first="Jesus" last="Gomez-Navarro">Jesus Gomez-Navarro</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Huang, Bo" sort="Huang, Bo" uniqKey="Huang B" first="Bo" last="Huang">Bo Huang</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Pavlov, Dmitri" sort="Pavlov, Dmitri" uniqKey="Pavlov D" first="Dmitri" last="Pavlov">Dmitri Pavlov</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23295794</idno><idno type="pmc">4878048</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878048</idno><idno type="RBID">PMC:4878048</idno><idno type="doi">10.1200/JCO.2012.44.6112</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">000453</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000453</idno><idno type="wicri:Area/Pmc/Curation">000453</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000453</idno><idno type="wicri:Area/Pmc/Checkpoint">001957</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001957</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma</title><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Marshall, Margaret A" sort="Marshall, Margaret A" uniqKey="Marshall M" first="Margaret A." last="Marshall">Margaret A. Marshall</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Punt, Cornelis J A" sort="Punt, Cornelis J A" uniqKey="Punt C" first="Cornelis J. A." last="Punt">Cornelis J. A. Punt</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Haanen, John B" sort="Haanen, John B" uniqKey="Haanen J" first="John B." last="Haanen">John B. Haanen</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Marmol, Maribel" sort="Marmol, Maribel" uniqKey="Marmol M" first="Maribel" last="Marmol">Maribel Marmol</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Schachter, Jacob" sort="Schachter, Jacob" uniqKey="Schachter J" first="Jacob" last="Schachter">Jacob Schachter</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Linette, Gerald" sort="Linette, Gerald" uniqKey="Linette G" first="Gerald" last="Linette">Gerald Linette</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Kendra, Kari L" sort="Kendra, Kari L" uniqKey="Kendra K" first="Kari L." last="Kendra">Kari L. Kendra</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Smylie, Michael" sort="Smylie, Michael" uniqKey="Smylie M" first="Michael" last="Smylie">Michael Smylie</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dreno">Brigitte Dreno</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Nathan, Paul D" sort="Nathan, Paul D" uniqKey="Nathan P" first="Paul D." last="Nathan">Paul D. Nathan</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Mackiewicz, Jacek" sort="Mackiewicz, Jacek" uniqKey="Mackiewicz J" first="Jacek" last="Mackiewicz">Jacek Mackiewicz</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Gomez Navarro, Jesus" sort="Gomez Navarro, Jesus" uniqKey="Gomez Navarro J" first="Jesus" last="Gomez-Navarro">Jesus Gomez-Navarro</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Huang, Bo" sort="Huang, Bo" uniqKey="Huang B" first="Bo" last="Huang">Bo Huang</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Pavlov, Dmitri" sort="Pavlov, Dmitri" uniqKey="Pavlov D" first="Dmitri" last="Pavlov">Dmitri Pavlov</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author><author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><affiliation><nlm:aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</nlm:aff><wicri:noCountry code="subfield">PA.</wicri:noCountry></affiliation></author></analytic><series><title level="j">Journal of Clinical Oncology</title><idno type="ISSN">0732-183X</idno><idno type="eISSN">1527-7755</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy.</p></sec><sec><title>Patients and Methods</title><p>Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine).</p></sec><sec><title>Results</title><p>In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; <italic>P</italic> = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 <italic>v</italic> 13.7 months; <italic>P</italic> = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor.</p></sec><sec><title>Conclusion</title><p>This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Oncol</journal-id><journal-id journal-id-type="iso-abbrev">J. Clin. Oncol</journal-id><journal-id journal-id-type="hwp">jco</journal-id><journal-id journal-id-type="pmc">jco</journal-id><journal-id journal-id-type="publisher-id">JCO</journal-id><journal-title-group><journal-title>Journal of Clinical Oncology</journal-title></journal-title-group><issn pub-type="ppub">0732-183X</issn><issn pub-type="epub">1527-7755</issn><publisher><publisher-name>American Society of Clinical Oncology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">23295794</article-id><article-id pub-id-type="pmc">4878048</article-id><article-id pub-id-type="publisher-id">46112</article-id><article-id pub-id-type="doi">10.1200/JCO.2012.44.6112</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>Mela5</subject></subj-group><subj-group subj-group-type="heading"><subject>Original Reports</subject><subj-group><subject>Melanoma</subject></subj-group></subj-group></article-categories><title-group><article-title>Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma</article-title><alt-title alt-title-type="short">Tremelimumab Phase III Trial in Patients With Advanced Melanoma</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Ribas</surname><given-names>Antoni</given-names></name><xref ref-type="aff" rid="aff1"></xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author"><name><surname>Kefford</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Marshall</surname><given-names>Margaret A.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Punt</surname><given-names>Cornelis J.A.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Haanen</surname><given-names>John B.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Marmol</surname><given-names>Maribel</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Garbe</surname><given-names>Claus</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Gogas</surname><given-names>Helen</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Schachter</surname><given-names>Jacob</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Linette</surname><given-names>Gerald</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Lorigan</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Kendra</surname><given-names>Kari L.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Maio</surname><given-names>Michele</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Trefzer</surname><given-names>Uwe</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Smylie</surname><given-names>Michael</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>McArthur</surname><given-names>Grant A.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Dreno</surname><given-names>Brigitte</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Nathan</surname><given-names>Paul D.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Mackiewicz</surname><given-names>Jacek</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Kirkwood</surname><given-names>John M.</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Gomez-Navarro</surname><given-names>Jesus</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Huang</surname><given-names>Bo</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Pavlov</surname><given-names>Dmitri</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><contrib contrib-type="author"><name><surname>Hauschild</surname><given-names>Axel</given-names></name><xref ref-type="aff" rid="aff1"></xref></contrib><aff id="aff1">Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Richard Kefford, Westmead Institute for Cancer Research and Melanoma Institute Australia, University of Sydney at Westmead Hospital, Sydney, New South Wales; Grant A. McArthur, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia; Margaret A. Marshall, Jesus Gomez-Navarro, Bo Huang, and Dmitri Pavlov, Pfizer Global Research and Development, Groton, CT; Cornelis J.A. Punt, Radboud University Nijmegen Medical Center, Nijmegen; John B. Haanen, Netherlands Cancer Institute, Amsterdam, the Netherlands; Maribel Marmol, Hospital Clinic of Barcelona, Barcelona, Spain; Claus Garbe, University Hospital Tübingen, Tübingen; Uwe Trefzer, Skin Cancer Center, Charité Universitätsmedizin Berlin, Berlin; Axel Hauschild, University of Kiel, Kiel, Germany; Helen Gogas, University of Athens, Athens, Greece; Jacob Schachter, Sheba Medical Centre, Tel Hashomer, Israel; Gerald Linette, Washington University School of Medicine, St Louis, MO; Paul Lorigan, Christie Hospital, National Health Service Foundation Trust, Manchester; Paul D. Nathan, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom; Kari L. Kendra, Arthur G. James Cancer Hospital and Richard J. Solve Research Institute, Columbus, OH; Michele Maio, Immunoterapia Oncologica–Azienda Ospedaliera Universitaria Senese, Siena, Italy; Michael Smylie, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Brigitte Dreno, Centre Hospitalier Universitaire de Nantes–Hôtel Dieu, Clinique Dermatologique, Nantes, France; Jacek Mackiewicz, Zaklad Diagnostyki i Immunologii Nowotworow Wielkopolskie Centrum Onkologii, University of Medical Sciences, Poznan, Poland; and John M. Kirkwood, University of Pittsburgh School of Medicine, Pittsburgh, PA.</aff></contrib-group><author-notes><corresp id="cor1">Corresponding author: Antoni Ribas, MD, Division of Hematology-Oncology, 11-934 Factor Building, UCLA Medical Center, 10833 Le Conte Ave, Los Angeles, CA 90095-1782; e-mail: <email>aribas@mednet.ucla.edu</email>.</corresp></author-notes><pub-date pub-type="ppub"><day>10</day><month>2</month><year>2013</year></pub-date><pub-date pub-type="epub"><day>7</day><month>1</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>7</day><month>1</month><year>2013</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>31</volume><issue>5</issue><fpage>616</fpage><lpage>622</lpage><permissions><copyright-statement>© 2013 by American Society of Clinical Oncology</copyright-statement><copyright-year>2013</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="zlj00513000616.pdf"></self-uri><abstract><sec><title>Purpose</title><p>In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy.</p></sec><sec><title>Patients and Methods</title><p>Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine).</p></sec><sec><title>Results</title><p>In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; <italic>P</italic> = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 <italic>v</italic> 13.7 months; <italic>P</italic> = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor.</p></sec><sec><title>Conclusion</title><p>This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.</p></sec></abstract></article-meta></front></pmc><affiliations><list></list><tree><noCountry><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dreno">Brigitte Dreno</name><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name><name sortKey="Gogas, Helen" sort="Gogas, Helen" uniqKey="Gogas H" first="Helen" last="Gogas">Helen Gogas</name><name sortKey="Gomez Navarro, Jesus" sort="Gomez Navarro, Jesus" uniqKey="Gomez Navarro J" first="Jesus" last="Gomez-Navarro">Jesus Gomez-Navarro</name><name sortKey="Haanen, John B" sort="Haanen, John B" uniqKey="Haanen J" first="John B." last="Haanen">John B. Haanen</name><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name><name sortKey="Huang, Bo" sort="Huang, Bo" uniqKey="Huang B" first="Bo" last="Huang">Bo Huang</name><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><name sortKey="Kendra, Kari L" sort="Kendra, Kari L" uniqKey="Kendra K" first="Kari L." last="Kendra">Kari L. Kendra</name><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name><name sortKey="Linette, Gerald" sort="Linette, Gerald" uniqKey="Linette G" first="Gerald" last="Linette">Gerald Linette</name><name sortKey="Lorigan, Paul" sort="Lorigan, Paul" uniqKey="Lorigan P" first="Paul" last="Lorigan">Paul Lorigan</name><name sortKey="Mackiewicz, Jacek" sort="Mackiewicz, Jacek" uniqKey="Mackiewicz J" first="Jacek" last="Mackiewicz">Jacek Mackiewicz</name><name sortKey="Maio, Michele" sort="Maio, Michele" uniqKey="Maio M" first="Michele" last="Maio">Michele Maio</name><name sortKey="Marmol, Maribel" sort="Marmol, Maribel" uniqKey="Marmol M" first="Maribel" last="Marmol">Maribel Marmol</name><name sortKey="Marshall, Margaret A" sort="Marshall, Margaret A" uniqKey="Marshall M" first="Margaret A." last="Marshall">Margaret A. Marshall</name><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name><name sortKey="Nathan, Paul D" sort="Nathan, Paul D" uniqKey="Nathan P" first="Paul D." last="Nathan">Paul D. Nathan</name><name sortKey="Pavlov, Dmitri" sort="Pavlov, Dmitri" uniqKey="Pavlov D" first="Dmitri" last="Pavlov">Dmitri Pavlov</name><name sortKey="Punt, Cornelis J A" sort="Punt, Cornelis J A" uniqKey="Punt C" first="Cornelis J. A." last="Punt">Cornelis J. A. Punt</name><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><name sortKey="Schachter, Jacob" sort="Schachter, Jacob" uniqKey="Schachter J" first="Jacob" last="Schachter">Jacob Schachter</name><name sortKey="Smylie, Michael" sort="Smylie, Michael" uniqKey="Smylie M" first="Michael" last="Smylie">Michael Smylie</name><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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