Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.
Identifieur interne : 003467 ( PubMed/Corpus ); précédent : 003466; suivant : 003468Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.
Auteurs : Caroline Robert ; Antoni Ribas ; Jedd D. Wolchok ; F Stephen Hodi ; Omid Hamid ; Richard Kefford ; Jeffrey S. Weber ; Anthony M. Joshua ; Wen-Jen Hwu ; Tara C. Gangadhar ; Amita Patnaik ; Roxana Dronca ; Hassane Zarour ; Richard W. Joseph ; Peter Boasberg ; Bartosz Chmielowski ; Christine Mateus ; Michael A. Postow ; Kevin Gergich ; Jeroen Elassaiss-Schaap ; Xiaoyun Nicole Li ; Robert Iannone ; Scot W. Ebbinghaus ; S Peter Kang ; Adil DaudSource :
- Lancet (London, England) [ 1474-547X ] ; 2014.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal (therapeutic use), Antibodies, Monoclonal, Humanized, Antineoplastic Agents (administration & dosage), Antineoplastic Agents (adverse effects), Dose-Response Relationship, Drug, Drug Eruptions (etiology), Drug Resistance, Neoplasm, Fatigue (chemically induced), Female, Humans, Male, Melanoma (drug therapy), Middle Aged, Programmed Cell Death 1 Receptor (antagonists & inhibitors), Pruritus (chemically induced), Skin Neoplasms (drug therapy), Treatment Outcome, Young Adult.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Antineoplastic Agents.
- chemical , adverse effects : Antibodies, Monoclonal, Antineoplastic Agents.
- chemical , antagonists & inhibitors : Programmed Cell Death 1 Receptor.
- chemical , therapeutic use : Antibodies, Monoclonal.
- chemically induced : Fatigue, Pruritus.
- drug therapy : Melanoma, Skin Neoplasms.
- etiology : Drug Eruptions.
- Adolescent, Adult, Aged, Antibodies, Monoclonal, Humanized, Dose-Response Relationship, Drug, Drug Resistance, Neoplasm, Female, Humans, Male, Middle Aged, Treatment Outcome, Young Adult.
Abstract
The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.
DOI: 10.1016/S0140-6736(14)60958-2
PubMed: 25034862
Links to Exploration step
pubmed:25034862Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.</title><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France. Electronic address: caroline.robert@gustaveroussy.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation></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:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F Stephen" last="Hodi">F Stephen Hodi</name><affiliation><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation><nlm:affiliation>Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Westmead, NSW, Australia; University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S" last="Weber">Jeffrey S. Weber</name><affiliation><nlm:affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation></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:affiliation>Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></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:affiliation>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name><affiliation><nlm:affiliation>South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name><affiliation><nlm:affiliation>Mayo Clinic, Rochester, MN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name><affiliation><nlm:affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W" last="Joseph">Richard W. Joseph</name><affiliation><nlm:affiliation>Mayo Clinic, Jacksonville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Boasberg, Peter" sort="Boasberg, Peter" uniqKey="Boasberg P" first="Peter" last="Boasberg">Peter Boasberg</name><affiliation><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name><affiliation><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mateus, Christine" sort="Mateus, Christine" uniqKey="Mateus C" first="Christine" last="Mateus">Christine Mateus</name><affiliation><nlm:affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France.</nlm:affiliation></affiliation></author><author><name sortKey="Postow, Michael A" sort="Postow, Michael A" uniqKey="Postow M" first="Michael A" last="Postow">Michael A. Postow</name><affiliation><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gergich, Kevin" sort="Gergich, Kevin" uniqKey="Gergich K" first="Kevin" last="Gergich">Kevin Gergich</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Elassaiss Schaap, Jeroen" sort="Elassaiss Schaap, Jeroen" uniqKey="Elassaiss Schaap J" first="Jeroen" last="Elassaiss-Schaap">Jeroen Elassaiss-Schaap</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></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:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Iannone, Robert" sort="Iannone, Robert" uniqKey="Iannone R" first="Robert" last="Iannone">Robert Iannone</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ebbinghaus, Scot W" sort="Ebbinghaus, Scot W" uniqKey="Ebbinghaus S" first="Scot W" last="Ebbinghaus">Scot W. Ebbinghaus</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></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:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><affiliation><nlm:affiliation>University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25034862</idno><idno type="pmid">25034862</idno><idno type="doi">10.1016/S0140-6736(14)60958-2</idno><idno type="wicri:Area/PubMed/Corpus">003467</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003467</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.</title><author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name><affiliation><nlm:affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France. Electronic address: caroline.robert@gustaveroussy.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation></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:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hodi, F Stephen" sort="Hodi, F Stephen" uniqKey="Hodi F" first="F Stephen" last="Hodi">F Stephen Hodi</name><affiliation><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name><affiliation><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name><affiliation><nlm:affiliation>Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Westmead, NSW, Australia; University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Weber, Jeffrey S" sort="Weber, Jeffrey S" uniqKey="Weber J" first="Jeffrey S" last="Weber">Jeffrey S. Weber</name><affiliation><nlm:affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</nlm:affiliation></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:affiliation>Princess Margaret Cancer Centre, Toronto, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Hwu, Wen Jen" sort="Hwu, Wen Jen" uniqKey="Hwu W" first="Wen-Jen" last="Hwu">Wen-Jen Hwu</name><affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation></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:affiliation>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name><affiliation><nlm:affiliation>South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dronca, Roxana" sort="Dronca, Roxana" uniqKey="Dronca R" first="Roxana" last="Dronca">Roxana Dronca</name><affiliation><nlm:affiliation>Mayo Clinic, Rochester, MN, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Zarour, Hassane" sort="Zarour, Hassane" uniqKey="Zarour H" first="Hassane" last="Zarour">Hassane Zarour</name><affiliation><nlm:affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Joseph, Richard W" sort="Joseph, Richard W" uniqKey="Joseph R" first="Richard W" last="Joseph">Richard W. Joseph</name><affiliation><nlm:affiliation>Mayo Clinic, Jacksonville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Boasberg, Peter" sort="Boasberg, Peter" uniqKey="Boasberg P" first="Peter" last="Boasberg">Peter Boasberg</name><affiliation><nlm:affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Chmielowski, Bartosz" sort="Chmielowski, Bartosz" uniqKey="Chmielowski B" first="Bartosz" last="Chmielowski">Bartosz Chmielowski</name><affiliation><nlm:affiliation>University of California Los Angeles, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mateus, Christine" sort="Mateus, Christine" uniqKey="Mateus C" first="Christine" last="Mateus">Christine Mateus</name><affiliation><nlm:affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France.</nlm:affiliation></affiliation></author><author><name sortKey="Postow, Michael A" sort="Postow, Michael A" uniqKey="Postow M" first="Michael A" last="Postow">Michael A. Postow</name><affiliation><nlm:affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gergich, Kevin" sort="Gergich, Kevin" uniqKey="Gergich K" first="Kevin" last="Gergich">Kevin Gergich</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Elassaiss Schaap, Jeroen" sort="Elassaiss Schaap, Jeroen" uniqKey="Elassaiss Schaap J" first="Jeroen" last="Elassaiss-Schaap">Jeroen Elassaiss-Schaap</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></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:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Iannone, Robert" sort="Iannone, Robert" uniqKey="Iannone R" first="Robert" last="Iannone">Robert Iannone</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ebbinghaus, Scot W" sort="Ebbinghaus, Scot W" uniqKey="Ebbinghaus S" first="Scot W" last="Ebbinghaus">Scot W. Ebbinghaus</name><affiliation><nlm:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></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:affiliation>Merck, Whitehouse Station, NJ, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name><affiliation><nlm:affiliation>University of California San Francisco, San Francisco, CA, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="eISSN">1474-547X</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antibodies, Monoclonal (administration & dosage)</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Antibodies, Monoclonal (therapeutic use)</term><term>Antibodies, Monoclonal, Humanized</term><term>Antineoplastic Agents (administration & dosage)</term><term>Antineoplastic Agents (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Drug Eruptions (etiology)</term><term>Drug Resistance, Neoplasm</term><term>Fatigue (chemically induced)</term><term>Female</term><term>Humans</term><term>Male</term><term>Melanoma (drug therapy)</term><term>Middle Aged</term><term>Programmed Cell Death 1 Receptor (antagonists & inhibitors)</term><term>Pruritus (chemically induced)</term><term>Skin Neoplasms (drug therapy)</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Programmed Cell Death 1 Receptor</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Fatigue</term><term>Pruritus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Melanoma</term><term>Skin Neoplasms</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug Eruptions</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Antibodies, Monoclonal, Humanized</term><term>Dose-Response Relationship, Drug</term><term>Drug Resistance, Neoplasm</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25034862</PMID><DateCreated><Year>2014</Year><Month>09</Month><Day>22</Day></DateCreated><DateCompleted><Year>2014</Year><Month>12</Month><Day>10</Day></DateCompleted><DateRevised><Year>2017</Year><Month>11</Month><Day>16</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-547X</ISSN><JournalIssue CitedMedium="Internet"><Volume>384</Volume><Issue>9948</Issue><PubDate><Year>2014</Year><Month>Sep</Month><Day>20</Day></PubDate></JournalIssue><Title>Lancet (London, England)</Title><ISOAbbreviation>Lancet</ISOAbbreviation></Journal><ArticleTitle>Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial.</ArticleTitle><Pagination><MedlinePgn>1109-17</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S0140-6736(14)60958-2</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0140-6736(14)60958-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The anti-programmed-death-receptor-1 (PD-1) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma. We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In an open-label, international, multicentre expansion cohort of a phase 1 trial, patients (aged ≥18 years) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule (1:1 final ratio) to intravenous pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every 3 weeks until disease progression, intolerable toxicity, or consent withdrawal. Primary endpoint was overall response rate (ORR) assessed with the Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) by independent central review. Analysis was done on the full-analysis set (all treated patients with measurable disease at baseline). This study is registered with ClinicalTrials.gov, number NCT01295827.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">173 patients received pembrolizumab 2 mg/kg (n=89) or 10 mg/kg (n=84). Median follow-up duration was 8 months. ORR was 26% at both doses--21 of 81 patients in the 2 mg/kg group and 20 of 76 in the 10 mg/kg group (difference 0%, 95% CI -14 to 13; p=0·96). Treatment was well tolerated, with similar safety profiles in the 2 mg/kg and 10 mg/kg groups and no drug-related deaths. The most common drug-related adverse events of any grade in the 2 mg/kg and 10 mg/kg groups were fatigue (29 [33%] vs 31 [37%]), pruritus (23 [26%] vs 16 [19%]), and rash (16 [18%] vs 15 [18%]). Grade 3 fatigue, reported in five (3%) patients in the 2 mg/kg pembrolizumab group, was the only drug-related grade 3 to 4 adverse event reported in more than one patient.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 weeks might be an effective treatment in patients for whom there are few effective treatment options.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Merck Sharp and Dohme.</AbstractText><CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France. Electronic address: caroline.robert@gustaveroussy.fr.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ribas</LastName><ForeName>Antoni</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>University of California Los Angeles, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wolchok</LastName><ForeName>Jedd D</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>Memorial Sloan-Kettering Cancer Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hodi</LastName><ForeName>F Stephen</ForeName><Initials>FS</Initials><AffiliationInfo><Affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hamid</LastName><ForeName>Omid</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kefford</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Crown Princess Mary Cancer Centre, Westmead Hospital and Melanoma Institute Australia, Westmead, NSW, Australia; University of Sydney, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weber</LastName><ForeName>Jeffrey S</ForeName><Initials>JS</Initials><AffiliationInfo><Affiliation>H Lee Moffitt Cancer Center, Tampa, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joshua</LastName><ForeName>Anthony M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Princess Margaret Cancer Centre, Toronto, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hwu</LastName><ForeName>Wen-Jen</ForeName><Initials>WJ</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gangadhar</LastName><ForeName>Tara C</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Patnaik</LastName><ForeName>Amita</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dronca</LastName><ForeName>Roxana</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Mayo Clinic, Rochester, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zarour</LastName><ForeName>Hassane</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>University of Pittsburgh, Pittsburgh, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Joseph</LastName><ForeName>Richard W</ForeName><Initials>RW</Initials><AffiliationInfo><Affiliation>Mayo Clinic, Jacksonville, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boasberg</LastName><ForeName>Peter</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Angeles Clinic and Research Institute, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chmielowski</LastName><ForeName>Bartosz</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>University of California Los Angeles, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mateus</LastName><ForeName>Christine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Gustave Roussy and INSERM U981, Paris-Sud, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Postow</LastName><ForeName>Michael A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Memorial Sloan-Kettering Cancer Center, New York, 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