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Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab

Identifieur interne : 001F54 ( Main/Exploration ); précédent : 001F53; suivant : 001F55

Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab

Auteurs : F. Stephen Hodi ; Wen-Jen Hwu ; Richard Kefford ; Jeffrey S. Weber ; Adil Daud ; Omid Hamid ; Amita Patnaik ; Antoni Ribas ; Caroline Robert ; Tara C. Gangadhar ; Anthony M. Joshua ; Peter Hersey ; Roxana Dronca ; Richard Joseph ; Darcy Hille ; Dahai Xue ; Xiaoyun Nicole Li ; S. Peter Kang ; Scot Ebbinghaus ; Andrea Perrone ; Jedd D. Wolchok

Source :

RBID : PMC:5070547

Descripteurs français

English descriptors

Abstract

Purpose

We evaluated atypical response patterns and the relationship between overall survival and best overall response measured per immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) in patients with advanced melanoma treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinical trial information: NCT01295827).

Patients and Methods

Patients received pembrolizumab 2 or 10 mg/kg every 2 weeks or every 3 weeks. Atypical responses were identified by using centrally assessed irRC data in patients with ≥ 28 weeks of imaging. Pseudoprogression was defined as ≥ 25% increase in tumor burden at week 12 (early) or any assessment after week 12 (delayed) that was not confirmed as progressive disease at next assessment. Response was assessed centrally per irRC and RECIST v1.1.

Results

Of the 655 patients with melanoma enrolled, 327 had ≥ 28 weeks of imaging follow-up. Twenty-four (7%) of these 327 patients had atypical responses (15 [5%] with early pseudoprogression and nine [3%] with delayed pseudoprogression). Of the 592 patients who survived ≥ 12 weeks, 84 (14%) experienced progressive disease per RECIST v1.1 but nonprogressive disease per irRC. Two-year overall survival rates were 77.6% in patients with nonprogressive disease per both criteria (n = 331), 37.5% in patients with progressive disease per RECIST v1.1 but nonprogressive disease per irRC (n = 84), and 17.3% in patients with progressive disease per both criteria (n = 177).

Conclusion

Atypical responses were observed in patients with melanoma treated with pembrolizumab. Based on survival analysis, conventional RECIST might underestimate the benefit of pembrolizumab in approximately 15% of patients; modified criteria that permit treatment beyond initial progression per RECIST v1.1 might prevent premature cessation of treatment.


Url:
DOI: 10.1200/JCO.2015.64.0391
PubMed: 26951310
PubMed Central: 5070547


Affiliations:


Links toward previous steps (curation, corpus...)


Le document en format XML

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<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
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<author>
<name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Joseph, Richard" sort="Joseph, Richard" uniqKey="Joseph R" first="Richard" last="Joseph">Richard Joseph</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Xue, Dahai" sort="Xue, Dahai" uniqKey="Xue D" first="Dahai" last="Xue">Dahai Xue</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Ebbinghaus, Scot" sort="Ebbinghaus, Scot" uniqKey="Ebbinghaus S" first="Scot" last="Ebbinghaus">Scot Ebbinghaus</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<title xml:lang="en" level="a" type="main">Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab</title>
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<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
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<name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
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<name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
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<name sortKey="Joseph, Richard" sort="Joseph, Richard" uniqKey="Joseph R" first="Richard" last="Joseph">Richard Joseph</name>
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<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
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<name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
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<name sortKey="Xue, Dahai" sort="Xue, Dahai" uniqKey="Xue D" first="Dahai" last="Xue">Dahai Xue</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Ebbinghaus, Scot" sort="Ebbinghaus, Scot" uniqKey="Ebbinghaus S" first="Scot" last="Ebbinghaus">Scot Ebbinghaus</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Perrone, Andrea" sort="Perrone, Andrea" uniqKey="Perrone A" first="Andrea" last="Perrone">Andrea Perrone</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name>
<affiliation>
<nlm:aff id="aff1">F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Wen-Jen Hwu, The University of Texas MD Anderson Cancer Center, Houston; Amita Patnaik, South Texas Accelerated Research Therapeutics, San Antonio, TX; Richard Kefford, Westmead Hospital, Melanoma Institute Australia, and Macquarie University; Peter Hersey, University of Sydney, Sydney, Australia; Jeffrey S. Weber, H. Lee Moffitt Cancer Center, Tampa; Richard Joseph, Mayo Clinic, Jacksonville, FL; Adil Daud, University of California San Francisco, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute; Antoni Ribas, University of California Los Angeles, Los Angeles, CA; Caroline Robert, Gustave-Roussy and Paris-Sud University, Villejuif-Paris-Sud, France; Tara C. Gangadhar, Abramson Cancer Center, Philadelphia, PA; Anthony M. Joshua, Princess Margaret Hospital, Toronto, Ontario, Canada; Roxana Dronca, Mayo Clinic, Rochester, MN; Darcy Hille, Dahai Xue, Xiaoyun Nicole Li, S. Peter Kang, Scot Ebbinghaus, and Andrea Perrone, Merck, Kenilworth, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.</nlm:aff>
<wicri:noCountry code="subfield">NY.</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="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Aged</term>
<term>Antibodies, Monoclonal, Humanized (immunology)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Antineoplastic Agents (immunology)</term>
<term>Antineoplastic Agents (therapeutic use)</term>
<term>Female</term>
<term>Humans</term>
<term>Melanoma (drug therapy)</term>
<term>Melanoma (immunology)</term>
<term>Middle Aged</term>
<term>Response Evaluation Criteria in Solid Tumors</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Anticorps monoclonaux humanisés (immunologie)</term>
<term>Anticorps monoclonaux humanisés (usage thérapeutique)</term>
<term>Antinéoplasiques (immunologie)</term>
<term>Antinéoplasiques (usage thérapeutique)</term>
<term>Critères d'évaluation de la réponse dans les tumeurs solides</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mélanome (immunologie)</term>
<term>Mélanome (traitement médicamenteux)</term>
<term>Sujet âgé</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en">
<term>Antibodies, Monoclonal, Humanized</term>
<term>Antineoplastic Agents</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en">
<term>Antibodies, Monoclonal, Humanized</term>
<term>Antineoplastic Agents</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Melanoma</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr">
<term>Anticorps monoclonaux humanisés</term>
<term>Antinéoplasiques</term>
<term>Mélanome</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en">
<term>Melanoma</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr">
<term>Mélanome</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr">
<term>Anticorps monoclonaux humanisés</term>
<term>Antinéoplasiques</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Aged</term>
<term>Female</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Response Evaluation Criteria in Solid Tumors</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Critères d'évaluation de la réponse dans les tumeurs solides</term>
<term>Femelle</term>
<term>Humains</term>
<term>Sujet âgé</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Purpose</title>
<p>We evaluated atypical response patterns and the relationship between overall survival and best overall response measured per immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) in patients with advanced melanoma treated with pembrolizumab in the phase Ib KEYNOTE-001 study (clinical trial information: NCT01295827).</p>
</sec>
<sec>
<title>Patients and Methods</title>
<p>Patients received pembrolizumab 2 or 10 mg/kg every 2 weeks or every 3 weeks. Atypical responses were identified by using centrally assessed irRC data in patients with ≥ 28 weeks of imaging. Pseudoprogression was defined as ≥ 25% increase in tumor burden at week 12 (early) or any assessment after week 12 (delayed) that was not confirmed as progressive disease at next assessment. Response was assessed centrally per irRC and RECIST v1.1.</p>
</sec>
<sec>
<title>Results</title>
<p>Of the 655 patients with melanoma enrolled, 327 had ≥ 28 weeks of imaging follow-up. Twenty-four (7%) of these 327 patients had atypical responses (15 [5%] with early pseudoprogression and nine [3%] with delayed pseudoprogression). Of the 592 patients who survived ≥ 12 weeks, 84 (14%) experienced progressive disease per RECIST v1.1 but nonprogressive disease per irRC. Two-year overall survival rates were 77.6% in patients with nonprogressive disease per both criteria (n = 331), 37.5% in patients with progressive disease per RECIST v1.1 but nonprogressive disease per irRC (n = 84), and 17.3% in patients with progressive disease per both criteria (n = 177).</p>
</sec>
<sec>
<title>Conclusion</title>
<p>Atypical responses were observed in patients with melanoma treated with pembrolizumab. Based on survival analysis, conventional RECIST might underestimate the benefit of pembrolizumab in approximately 15% of patients; modified criteria that permit treatment beyond initial progression per RECIST v1.1 might prevent premature cessation of treatment.</p>
</sec>
</div>
</front>
</TEI>
<affiliations>
<list></list>
<tree>
<noCountry>
<name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
<name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name>
<name sortKey="Ebbinghaus, Scot" sort="Ebbinghaus, Scot" uniqKey="Ebbinghaus S" first="Scot" last="Ebbinghaus">Scot Ebbinghaus</name>
<name sortKey="Gangadhar, Tara C" sort="Gangadhar, Tara C" uniqKey="Gangadhar T" first="Tara C." last="Gangadhar">Tara C. Gangadhar</name>
<name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
<name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
<name sortKey="Hille, Darcy" sort="Hille, Darcy" uniqKey="Hille D" first="Darcy" last="Hille">Darcy Hille</name>
<name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F. Stephen" last="Hodi">F. Stephen Hodi</name>
<name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name>
<name sortKey="Joseph, Richard" sort="Joseph, Richard" uniqKey="Joseph R" first="Richard" last="Joseph">Richard Joseph</name>
<name sortKey="Joshua, Anthony M" sort="Joshua, Anthony M" uniqKey="Joshua A" first="Anthony M." last="Joshua">Anthony M. Joshua</name>
<name sortKey="Kang, S Peter" sort="Kang, S Peter" uniqKey="Kang S" first="S. Peter" last="Kang">S. Peter Kang</name>
<name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name>
<name sortKey="Li, Xiaoyun Nicole" sort="Li, Xiaoyun Nicole" uniqKey="Li X" first="Xiaoyun Nicole" last="Li">Xiaoyun Nicole Li</name>
<name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name>
<name sortKey="Perrone, Andrea" sort="Perrone, Andrea" uniqKey="Perrone A" first="Andrea" last="Perrone">Andrea Perrone</name>
<name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
<name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S." last="Weber">Jeffrey S. Weber</name>
<name sortKey="Wolchok, Jedd D" sort="Wolchok, Jedd D" uniqKey="Wolchok J" first="Jedd D." last="Wolchok">Jedd D. Wolchok</name>
<name sortKey="Xue, Dahai" sort="Xue, Dahai" uniqKey="Xue D" first="Dahai" last="Xue">Dahai Xue</name>
</noCountry>
</tree>
</affiliations>
</record>

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