Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
7 other identifiers
interventional
976
16 countries
159
Brief Summary
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2018
Longer than P75 for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2021
CompletedResults Posted
Study results publicly available
June 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2033
ExpectedNovember 29, 2024
November 1, 2024
2.8 years
June 1, 2018
May 26, 2022
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-free Survival (RFS)
RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.
Up to ~32.7 months
Secondary Outcomes (4)
Distant Metastasis-free Survival (DMFS)
Up to ~9 years
Overall Survival (OS)
Up to ~15 years
Number of Participants Who Experienced at Least One Adverse Event (AE)
Up to ~19.3 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Up to ~19.3 months
Study Arms (2)
Pembrolizumab
EXPERIMENTALParticipants receive 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
Placebo
PLACEBO COMPARATORParticipants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
Interventions
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Eligibility Criteria
You may qualify if:
- Has surgically resected and histologically/pathologically confirmed new diagnosis of Stage IIB or IIC cutaneous melanoma per American Joint Committee on Cancer (AJCC) 8th edition guidelines
- Has not been previously treated for melanoma beyond complete surgical resection
- Has ≤12 weeks between final surgical resection and randomization
- Has no evidence of metastatic disease on imaging as determined by investigator
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants \>16 and \<18 years old
- Has recovered adequately from toxicity and/or complications from surgery prior to study start
- Female participants must not be pregnant or breastfeeding, and must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment if they are women of childbearing potential (WOCBP)
You may not qualify if:
- Has a known additional malignancy that is progressing or has required active antineoplastic therapy (including hormonal) within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-Programmed Cell Death Receptor Ligand 1 (PD-L1) or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
- Has received prior systemic anti-cancer therapy for melanoma including investigational agents
- Has received a live vaccine within 30 days prior to the first dose of study treatment
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
- Has severe hypersensitivity (≥Grade 3) to any excipients of pembrolizumab
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus (defined as hepatitis C virus ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
- Has a history of active tuberculosis (Bacillus tuberculosis)
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (159)
University of Arizona Cancer Center ( Site 0121)
Tucson, Arizona, 85719, United States
UCSD Moores Cancer Center ( Site 0133)
La Jolla, California, 92037, United States
The Angeles Clinic and Research Institute ( Site 0029)
Los Angeles, California, 90025, United States
UCLA Hematology & Oncology ( Site 0130)
Los Angeles, California, 90095, United States
John Wayne Cancer Institute ( Site 0026)
Santa Monica, California, 90404, United States
University of Colorado Cancer Center ( Site 0027)
Aurora, Colorado, 80045, United States
Yale University ( Site 0035)
New Haven, Connecticut, 06511, United States
Mayo Clinic Florida ( Site 0024)
Jacksonville, Florida, 32224, United States
Moffitt McKinley Outpatient Center ( Site 0131)
Tampa, Florida, 33612, United States
Winship Cancer Institute of Emory University ( Site 0046)
Atlanta, Georgia, 30322-1013, United States
Northside Hospital ( Site 0115)
Atlanta, Georgia, 30341, United States
Northwestern Medical Group ( Site 0135)
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center ( Site 0007)
Chicago, Illinois, 60637, United States
Advocate Medical Group-Park Ridge ( Site 0025)
Park Ridge, Illinois, 60068, United States
University of Iowa Hospital and Clinics ( Site 0001)
Iowa City, Iowa, 52242, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ( Site 0126)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center ( Site 0141)
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute ( Site 0124)
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute ( Site 0111)
Detroit, Michigan, 48201, United States
Mayo Clinic [Rochester, MN] ( Site 0016)
Rochester, Minnesota, 55905, United States
Siteman Cancer Center ( Site 0143)
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering ( Site 0006)
Harrison, New York, 10604, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0137)
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center ( Site 0142)
New York, New York, 10022, United States
Mount Sinai Medical Center ( Site 0038)
New York, New York, 10029, United States
University of Rochester ( Site 0019)
Rochester, New York, 14642, United States
The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)
Cincinnati, Ohio, 45219, United States
Stephenson Cancer Center ( Site 0042)
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University ( Site 0032)
Portland, Oregon, 97239, United States
Children's Hospital of Pittsburgh UPMC ( Site 0144)
Pittsburgh, Pennsylvania, 15224, United States
UPMC Hillman Cancer Centers ( Site 0043)
Pittsburgh, Pennsylvania, 15232, United States
West Cancer Center - East Campus ( Site 0022)
Germantown, Tennessee, 38138, United States
University of Tennessee Medical Center Knoxville ( Site 0116)
Knoxville, Tennessee, 37920, United States
University of Texas-MD Anderson Cancer Center ( Site 0134)
Houston, Texas, 77030, United States
Inova Schar Cancer Institute ( Site 0014)
Fairfax, Virginia, 22031, United States
VCU Massey Cancer Center ( Site 0008)
Richmond, Virginia, 23298, United States
Seattle Cancer Care Alliance ( Site 0044)
Seattle, Washington, 98109, United States
University of Wisconsin Hospital and Clinics ( Site 0030)
Madison, Wisconsin, 53792, United States
Melanoma Institute Australia ( Site 0856)
North Sydney, New South Wales, 2065, Australia
Westmead Hospital ( Site 0853)
Westmead, New South Wales, 2145, Australia
Cairns Base Hospital ( Site 0859)
Cairns, Queensland, 4870, Australia
Tasman Oncology Research Pty Ltd ( Site 0858)
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital ( Site 0857)
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital ( Site 0861)
Adelaide, South Australia, 5000, Australia
Ashford Cancer Centre Research ( Site 0860)
Kurralta Park, South Australia, 5037, Australia
The Alfred Hospital ( Site 0852)
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital ( Site 0851)
Murdoch, Western Australia, 6150, Australia
GZA Sint Augustinus ( Site 0259)
Wilrijk - Antwerpen, Antwerpen, 2610, Belgium
Institut Jules Bordet ( Site 0254)
Brussels, Bruxelles-Capitale, Region de, 1000, Belgium
Cliniques Universitaires Saint-Luc ( Site 0251)
Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)
Hasselt, Limburg, 3500, Belgium
UZ Gent ( Site 0255)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 0252)
Leuven, Vlaams-Brabant, 3000, Belgium
Hospital Erasto Gaertner ( Site 0159)
Curitiba, Paraná, 81520-060, Brazil
Hospital de Caridade de Ijui ( Site 0156)
Ijuí, Rio Grande do Sul, 98700 000, Brazil
Hospital Sao Vicente de Paulo ( Site 0158)
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)
Barretos, São Paulo, 14784-400, Brazil
Hospital de Clinicas de Rio Preto ( Site 0162)
Sao Jose Do Rio Preto - SP, São Paulo, 15090-000, Brazil
Instituto Nacional do Cancer II ( Site 0160)
Rio de Janeiro, 20220-410, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)
São Paulo, 01246-000, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)
São Paulo, 01321-001, Brazil
A.C. Camargo Cancer Center ( Site 0164)
São Paulo, 01508-010, Brazil
Cross Cancer Institute ( Site 0057)
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba ( Site 0053)
Winnipeg, Manitoba, R3E 0V9, Canada
Moncton Hospital - Horizon Health Network ( Site 0055)
Moncton, New Brunswick, E1C 6Z8, Canada
The Ottawa Hospital ( Site 0058)
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute ( Site 0060)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre ( Site 0059)
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuve Rosemont ( Site 0056)
Montreal, Quebec, H1T 2M4, Canada
Jewish General Hospital ( Site 0054)
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre ( Site 0062)
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)
Québec, Quebec, G1R 2J6, Canada
Fundacion Arturo Lopez Perez FALP ( Site 0200)
Santiago, Region M. de Santiago, 7500921, Chile
Pontificia Universidad Catolica de Chile ( Site 0201)
Santiago, Region M. de Santiago, 8330032, Chile
Sociedad Medica Aren y Bachero Limitada ( Site 0207)
Santiago, Region M. de Santiago, 8420383, Chile
Instituto Clinico Oncologico del Sur ( Site 0203)
Temuco, Región de la Araucanía, 4810469, Chile
Oncocentro ( Site 0204)
Viña del Mar, Región de Valparaíso, 2520598, Chile
Centro Oncologico Antofagasta ( Site 0206)
Antofagasta, 1240000, Chile
Hopital La Timone ( Site 0302)
Marseille, Bouches-du-Rhone, 13385, France
CHU Dijon Bourgogne ( Site 0320)
Dijon, Cote-d Or, 21000, France
CHU de Bordeaux- Hopital Saint Andre ( Site 0304)
Bordeaux, Gironde, 33075, France
Institut Claudius Regaud IUCT Oncopole ( Site 0306)
Toulouse, Haute-Garonne, 31059, France
Hopital Ambroise Pare Boulogne ( Site 0316)
Boulogne-Billancourt, Hauts-de-Seine, 92100, France
CHU Montpellier. ( Site 0312)
Montpellier, Herault, 34295, France
Centre Eugene Marquis ( Site 0305)
Rennes, Ille-et-Vilaine, 35042, France
CHU Angers ( Site 0321)
Angers, Maine-et-Loire, 49933, France
CHU de Reims ( Site 0307)
Reims, Marne, 51100, France
CHRU Lille - Hopital Claude Huriez ( Site 0301)
Lille, Nord, 59037, France
C.H.U. Lyon Sud ( Site 0303)
Pierre-Bénite, Rhone, 69495, France
CHU Amiens Picardie Hopital Nord ( Site 0317)
Amiens, Somme, 80054, France
Institut Gustave Roussy ( Site 0300)
Villejuif, Val-de-Marne, 94805, France
Hopital Saint Louis ( Site 0322)
Paris, 75475, France
Universitaetsklinikum in Mannheim ( Site 0351)
Mannheim, Baden-Wurttemberg, 68135, Germany
Universitaetsklinikum Tuebingen ( Site 0353)
Tübingen, Baden-Wurttemberg, 72076, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)
Munich, Bavaria, 80337, Germany
Klinikum Nuernberg Nord ( Site 0355)
Nuremberg, Bavaria, 90419, Germany
Klinikum der Universitaet in Wuerzburg ( Site 0356)
Würzburg, Bavaria, 97080, Germany
Elbe Klinikum Buxtehude ( Site 0354)
Buxtehude, Lower Saxony, 21614, Germany
Medizinische Hochschule Hannover ( Site 0358)
Hanover, Lower Saxony, 30625, Germany
Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)
Essen, North Rhine-Westphalia, 45147, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)
Kiel, Schleswig-Holstein, 24105, Germany
SRH Wald-Klinikum Gera GmbH ( Site 0360)
Gera, Thuringia, 07548, Germany
Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)
Hamburg, 20246, Germany
Soroka Medical Center ( Site 0653)
Beersheba, Southern District, 8457108, Israel
Sourasky Medical Center ( Site 0656)
Tel Aviv, Tell Abib, 6423906, Israel
HaEmek Medical Center ( Site 0655)
Afula, 1834111, Israel
Rambam Medical Center ( Site 0654)
Haifa, 3109601, Israel
Hadassah Ein Kerem Medical Center ( Site 0651)
Jerusalem, 9112001, Israel
Chaim Sheba Medical Center. ( Site 0652)
Ramat Gan, 5262000, Israel
Shamir Medical Center-Assaf Harofeh ( Site 0657)
Ẕerifin, 70300, Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)
Meldola, Forli-Cesena, 47014, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)
Bari, 70124, Italy
ASST Papa Giovanni XXIII ( Site 0402)
Bergamo, 24127, Italy
IRCCS A.O.U. San Martino - IST ( Site 0404)
Genova, 16132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)
Milan, 20133, Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)
Napoli, 80131, Italy
IRCCS Istituto Oncologico Veneto ( Site 0407)
Padua, 35128, Italy
IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)
Roma, 00167, Italy
Azienda Ospedaliero Universitaria Senese ( Site 0401)
Siena, 53100, Italy
National Cancer Center Hospital ( Site 0910)
Tokyo, 104-0045, Japan
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)
Poznan, Greater Poland Voivodeship, 60-780, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Pratia MCM Krakow ( Site 0773)
Krakow, Lesser Poland Voivodeship, 30-510, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)
Warsaw, Masovian Voivodeship, 02-781, Poland
Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)
Warsaw, Masovian Voivodeship, 04-730, Poland
Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0770)
Gdansk, Pomeranian Voivodeship, 80-402, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)
Bielsko-Biala, Silesian Voivodeship, 43-300, Poland
Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)
Katowice, Silesian Voivodeship, 40-514, Poland
LIFTMED ( Site 0765)
Rybnik, Silesian Voivodeship, 44-200, Poland
Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)
Port Elizabeth, Eastern Cape, 6045, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 0801)
Johannesburg, Gauteng, 2196, South Africa
Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)
Parktown, Gauteng, 2196, South Africa
Wilgers Oncology Centre ( Site 0806)
Pretoria, Gauteng, 0081, South Africa
MPOC ( Site 0803)
Pretoria, Gauteng, 0181, South Africa
Cancercare ( Site 0810)
Cape Town, Limpopo, 7700, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 0807)
Kraaifontein, Western Cape, 7570, South Africa
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Hospital General Universitario de Valencia ( Site 0451)
Valencia, Valenciana, Comunitat, 46014, Spain
Hospital General Universitari Vall d Hebron ( Site 0456)
Barcelona, 08035, Spain
Hospital Clinic de Barcelona ( Site 0452)
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Maranon ( Site 0454)
Madrid, 28009, Spain
Hospital Universitario Virgen Macarena ( Site 0455)
Seville, 41009, Spain
Universitaetsspital Basel ( Site 0554)
Basel, Canton of Basel-City, 4031, Switzerland
Universitaetsspital Bern ( Site 0552)
Bern, Canton of Bern, 3010, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 0556)
Geneva, Canton of Geneva, 1211, Switzerland
Kantonsspital St. Gallen ( Site 0559)
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Centre Hospitalier Universitaire Vaudois ( Site 0553)
Lausanne, Canton of Vaud, 1011, Switzerland
Universitaetsspital Zuerich ( Site 0551)
Zurich, Canton of Zurich, 8091, Switzerland
Oncological Institute of Southern Switzerland ( Site 0557)
Bellinzona, Canton Ticino, 6500, Switzerland
Kantonsspital Graubuenden ( Site 0555)
Chur, Kanton Graubünden, 7000, Switzerland
Hopital du Valais ( Site 0558)
Sion, Valais, 1951, Switzerland
Addenbrooke's Hospital in Cambridge ( Site 0600)
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 0601)
London, London, City of, SE1 9RT, United Kingdom
Royal Marsden Hospital - Fulham Road London ( Site 0613)
London, London, City of, SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0612)
Sutton, Surrey, SM2 5PT, United Kingdom
Christie NHS Foundation Trust ( Site 0604)
Manchester, M20 4GJ, United Kingdom
Related Publications (8)
Luke JJ, Ascierto PA, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Long GV. Pembrolizumab Versus Placebo as Adjuvant Therapy in Resected Stage IIB or IIC Melanoma: Final Analysis of Distant Metastasis-Free Survival in the Phase III KEYNOTE-716 Study. J Clin Oncol. 2024 May 10;42(14):1619-1624. doi: 10.1200/JCO.23.02355. Epub 2024 Mar 7.
PMID: 38452313RESULTLuke JJ, Ascierto PA, Khattak MA, Rutkowski P, Del Vecchio M, Spagnolo F, Mackiewicz J, Merino LC, Chiarion-Sileni V, Kirkwood JM, Robert C, Schadendorf D, de Galitiis F, Carlino MS, Dummer R, Mohr P, Odeleye-Ajakaye A, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Long GV. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Long-term follow-up, crossover, and rechallenge with pembrolizumab in the phase III KEYNOTE-716 study. Eur J Cancer. 2025 May 2;220:115381. doi: 10.1016/j.ejca.2025.115381. Epub 2025 Mar 23.
PMID: 40198940DERIVEDWurcel V, Rojas Rojas M, Urrego-Reyes J, Medrano Rivera D, Acevedo R, Jiang R, Jiang S, Zhang S, Caparros A, Krepler C, Fukunaga-Kalabis M, Younan ND, Alexander D, Hughes R, Weston G. Number needed to treat (NNT) with pembrolizumab as an adjuvant therapy in resected patients with high-risk stage II (IIB and IIC) melanoma and its application to cost of preventing an event (COPE) in Mexico. J Med Econ. 2025 Dec;28(1):346-353. doi: 10.1080/13696998.2025.2466365. Epub 2025 Mar 13.
PMID: 40078077DERIVEDSchadendorf D, Luke JJ, Ascierto PA, Long GV, Rutkowski P, Khattak A, Del Vecchio M, de la Cruz-Merino L, Mackiewicz J, Sileni VC, Kirkwood JM, Robert C, Grob JJ, Dummer R, Carlino MS, Zhao Y, Kalabis M, Krepler C, Eggermont A, Scolyer RA. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma: Outcomes in histopathologic subgroups from the randomized, double-blind, phase 3 KEYNOTE-716 trial. J Immunother Cancer. 2024 Mar 13;12(3):e007501. doi: 10.1136/jitc-2023-007501.
PMID: 38485189DERIVEDFavre-Bulle A, Bencina G, Zhang S, Jiang R, Andritschke D, Bhadhuri A. Cost-effectiveness of pembrolizumab as an adjuvant treatment for patients with resected stage IIB or IIC melanoma in Switzerland. J Med Econ. 2023 Jan-Dec;26(1):283-292. doi: 10.1080/13696998.2023.2174748.
PMID: 36748342DERIVEDLong GV, Luke JJ, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Mohr P, Dummer R, Gershenwald JE, Yoon CH, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Ascierto PA; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1378-1388. doi: 10.1016/S1470-2045(22)00559-9. Epub 2022 Oct 18.
PMID: 36265502DERIVEDLuke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1718-1729. doi: 10.1016/S0140-6736(22)00562-1. Epub 2022 Apr 1.
PMID: 35367007DERIVEDLuke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.
PMID: 31870188DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and Investigators will be blinded in Part 1 and unblinded in Part 2, if done.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 12, 2018
Study Start
September 12, 2018
Primary Completion
June 21, 2021
Study Completion (Estimated)
October 12, 2033
Last Updated
November 29, 2024
Results First Posted
June 24, 2022
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf