Evidence map›Paper›PMID 28212060›Full record

Trial reportThe New England journal of medicine2017

Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.

Joaquim Bellmunt, Ronald de Wit, David J Vaughn, Yves Fradet, Jae-Lyun Lee, Lawrence Fong, Nicholas J Vogelzang, Miguel A Climent, Daniel P Petrylak, Toni K Choueiri and 11 more

6 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 1,827 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,827citing papers in PubMed, 4 pooled it
348.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02256436 phase3completednot on this map

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2020Enrolled542ConditionsUrothelial CancerArmspembrolizumab, paclitaxel, vinflunine, docetaxel
NCT03447678 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

Phase II Study to Test Pembrolizumab (MK-3475) in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors (<50%)_ PEOPLE TRIAL (Pembrolizumab in Pd-L1 Low Expressors).

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2018 to 2022Enrolled65ConditionsNon Small Cell Lung Cancer (NSCLC)ArmsPembrolizumab
NCT03498196 phase1 / phase2terminatednot on this mapstarted 2018, after this paper: background citation

A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer (BL-AIR: Bladder Cancer-Avelumab for Invasive Resectable Disease)

TypeinterventionalSponsorBaylor College of MedicineRan2018 to 2019Enrolled1ConditionsBladder Cancer, Metastatic Bladder Cancer, Invasive Bladder CancerArmsAvelumab
NCT03832673 phase2withdrawnnot on this mapstarted 2019, after this paper: background citation

PECULIAR: An Open Label, Monocenter, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab and Epacadostat, Preceding Radical Cystectomy, for Patients With Muscle-invasive Bladder Cancer.

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2019 to 2019Enrolled0ConditionsMuscle-invasive Bladder CancerArmsPembrolizumab, Epacadostat
NCT04562311 phase2active not recruitingnot on this mapstarted 2021, after this paper: background citation

The Efficacy and Safety of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy:An Open, One-arm, Phase II Study

TypeinterventionalSponsorSun Yat-sen UniversityRan2021 to 2025Enrolled45ConditionsBladder Cancer Stage IVArmsChidamide
NCT04872036 completednot on this map

Investigation of Prognostic Biomarkers in Patients With Urothelial Carcinoma Treated With Platinum Regimens

TypeobservationalSponsorHellenic Cooperative Oncology GroupRan2000 to 2017Enrolled66ConditionsBladder Cancer
3 · Its place in the literature

Who cites it

1,827 citing papers in PubMed, 4 syntheses or guidelines pooled it, 3,353 citations in OpenAlex.

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  11. Treatment Efficacy and Molecular Dynamics of Neoadjuvant Durvalumab and Olaparib in Resectable Urothelial Bladder Cancer: The NEODURVARIB Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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1,767 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 9 institutions in 9 countries.

Joaquim BellmuntFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Ronald de WitFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
David J VaughnFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Yves FradetFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Jae-Lyun LeeFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Lawrence FongFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Nicholas J VogelzangFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Miguel A ClimentFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Daniel P PetrylakFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Toni K ChoueiriFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Andrea NecchiFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Winald GerritsenFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Howard GurneyFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
David I QuinnFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Stéphane CulineFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Cora N SternbergFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Yabing MaiFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Christian H PoehleinFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Rodolfo F PeriniFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
Dean F BajorinFrom Dana-Farber Cancer Institute, Boston (J.B., T.K.C.); Parc de Salut Mar, Hospital del Mar Medical Research Institute, Barcelona (J.B.), and Fundación Instituto Valenciano de Oncología, Valencia (M.A.C.) - both in Spain; Erasmus MC Cancer Institute, Rotterdam (R.W.), and Radboud University Medical Center, Nijmegen (W.G.) - both in the Netherlands; Abramson Cancer Center, University of Pennsylvania, Philadelphia (D.J.V.); Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC, Canada (Y.F.); Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea (J.-L.L.); the University of California, San Francisco, San Francisco (L.F.); Comprehensive Cancer Centers of Nevada, Las Vegas (N.J.V.); Smilow Cancer Hospital, Yale University, New Haven, CT (D.P.P.); Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (A.N.); Westmead Hospital and Macquarie University, Sydney (H.G.); the University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles (D.I.Q.); Hôpital Saint-Louis, Paris (S.C.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Merck, Kenilworth, NJ (Y.M., C.H.P., R.F.P.); and Memorial Sloan Kettering Cancer Center, New York (D.F.B.).
KEYNOTE-045 Investigators
Radboud University Medical Center · NLRadboud University Nijmegen · NLErasmus MC Cancer Institute · NLDana-Farber Cancer Institute · USFondazione IRCCS Istituto Nazionale dei Tumori · ITFundación Instituto Valenciano de Oncología · ESHôpital Saint-Louis · FRMemorial Sloan Kettering Cancer Center · USUniversity of Pennsylvania · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatients with advanced urothelial carcinoma that progresses after platinum-based chemotherapy have a poor prognosis and limited treatment options.

methodsIn this open-label, international, phase 3 trial, we randomly assigned 542 patients with advanced urothelial cancer that recurred or progressed after platinum-based chemotherapy to receive pembrolizumab (a highly selective, humanized monoclonal IgG4κ isotype antibody against programmed death 1 [PD-1]) at a dose of 200 mg every 3 weeks or the investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine. The coprimary end points were overall survival and progression-free survival, which were assessed among all patients and among patients who had a tumor PD-1 ligand (PD-L1) combined positive score (the percentage of PD-L1-expressing tumor and infiltrating immune cells relative to the total number of tumor cells) of 10% or more.

resultsThe median overall survival in the total population was 10.3 months (95% confidence interval [CI], 8.0 to 11.8) in the pembrolizumab group, as compared with 7.4 months (95% CI, 6.1 to 8.3) in the chemotherapy group (hazard ratio for death, 0.73; 95% CI, 0.59 to 0.91; P=0.002). The median overall survival among patients who had a tumor PD-L1 combined positive score of 10% or more was 8.0 months (95% CI, 5.0 to 12.3) in the pembrolizumab group, as compared with 5.2 months (95% CI, 4.0 to 7.4) in the chemotherapy group (hazard ratio, 0.57; 95% CI, 0.37 to 0.88; P=0.005). There was no significant between-group difference in the duration of progression-free survival in the total population (hazard ratio for death or disease progression, 0.98; 95% CI, 0.81 to 1.19; P=0.42) or among patients who had a tumor PD-L1 combined positive score of 10% or more (hazard ratio, 0.89; 95% CI, 0.61 to 1.28; P=0.24). Fewer treatment-related adverse events of any grade were reported in the pembrolizumab group than in the chemotherapy group (60.9% vs. 90.2%); there were also fewer events of grade 3, 4, or 5 severity reported in the pembrolizumab group than in the chemotherapy group (15.0% vs. 49.4%).

conclusionsPembrolizumab was associated with significantly longer overall survival (by approximately 3 months) and with a lower rate of treatment-related adverse events than chemotherapy as second-line therapy for platinum-refractory advanced urothelial carcinoma. (Funded by Merck; KEYNOTE-045 ClinicalTrials.gov number, NCT02256436 .).

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDocetaxelFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalPaclitaxelPlatinum CompoundsProgrammed Cell Death 1 ReceptorSurvival AnalysisTaxoidsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDocetaxelPaclitaxelPDCD1 protein, humanpembrolizumabPlatinum CompoundsProgrammed Cell Death 1 ReceptorTaxoidsVinblastinevinflunine

Identifiers

PMID28212060
PMCPMC5635424
OpenAlexW2588916311

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.