Melanoma Clinical Trial
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
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.
Eligibility Criteria
Inclusion:
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)
Exclusion:
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
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has had an allogeneic tissue/solid organ transplant
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There are 157 Locations for this study
Tucson Arizona, 85719, United States
La Jolla California, 92037, United States
Los Angeles California, 90025, United States
Los Angeles California, 90095, United States
Santa Monica California, 90404, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06511, United States
Jacksonville Florida, 32224, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30341, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Park Ridge Illinois, 60068, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Harrison New York, 10604, United States
New York New York, 10016, United States
New York New York, 10022, United States
New York New York, 10029, United States
Rochester New York, 14642, United States
Cincinnati Ohio, 45219, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37920, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53792, United States
North Sydney New South Wales, 2065, Australia
Westmead New South Wales, 2145, Australia
Cairns Queensland, 4870, Australia
Southport Queensland, 4215, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Kurralta Park South Australia, 5037, Australia
Melbourne Victoria, 3004, Australia
Murdoch Western Australia, 6150, Australia
Wilrijk - Antwerpen Antwerpen, 2610, Belgium
Brussels Bruxelles-Capitale, Region De, 1200, Belgium
Bruxelles Bruxelles-Capitale, Region De, 1000, Belgium
Hasselt Limburg, 3500, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Curitiba Parana, 81520, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Barretos Sao Paulo, 14784, Brazil
Sao Jose Do Rio Preto - SP Sao Paulo, 15090, Brazil
Rio de Janeiro , 20220, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01321, Brazil
Sao Paulo , 01508, Brazil
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R3E 0, Canada
Moncton New Brunswick, E1C 6, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Quebec , G1R 2, Canada
Temuco Araucania, 48104, Chile
Santiago Region M. De Santiago, 75009, Chile
Santiago Region M. De Santiago, 83300, Chile
Santiago Region M. De Santiago, 84203, Chile
Vina del Mar Valparaiso, 25205, Chile
Antofagasta , 12400, Chile
Marseille Bouches-du-Rhone, 13385, France
Dijon Cote-d Or, 21000, France
Bordeaux Gironde, 33075, France
Toulouse Haute-Garonne, 31059, France
Boulogne-Billancourt Hauts-de-Seine, 92100, France
Montpellier Herault, 34295, France
Rennes Ille-et-Vilaine, 35042, France
Angers Maine-et-Loire, 49933, France
Reims Marne, 51100, France
Lille Nord, 59037, France
Pierre Benite Rhone, 69495, France
Amiens Somme, 80054, France
Villejuif Val-de-Marne, 94805, France
Paris , 75475, France
Mannheim Baden-Wurttemberg, 68135, Germany
Tuebingen Baden-Wurttemberg, 72076, Germany
Muenchen Bayern, 80337, Germany
Nuernberg Bayern, 90419, Germany
Wuerzburg Bayern, 97080, Germany
Buxtehude Niedersachsen, 21614, Germany
Hannover Niedersachsen, 30625, Germany
Essen Nordrhein-Westfalen, 45147, Germany
Kiel Schleswig-Holstein, 24105, Germany
Gera Thuringen, 07548, Germany
Hamburg , 20246, Germany
Beer Sheva Southern, 84571, Israel
Tel Aviv Tell Abib, 64239, Israel
Afula , 18341, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52620, Israel
Zerifin , 70300, Israel
Meldola Forli-Cesena, 47014, Italy
Bari , 70124, Italy
Bergamo , 24127, Italy
Genova , 16132, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Roma , 00167, Italy
Siena , 53100, Italy
Tokyo , 104-0, Japan
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Krakow Malopolskie, 30-51, Poland
Warszawa Mazowieckie, 02-78, Poland
Warszawa Mazowieckie, 04-73, Poland
Rzeszow Podkarpackie, 35-05, Poland
Gdansk Pomorskie, 80-40, Poland
Bielsko-Biala Slaskie, 43-30, Poland
Katowice Slaskie, 40-51, Poland
Rybnik Slaskie, 44-20, Poland
Poznan Wielkopolskie, 60-78, Poland
Port Elizabeth Eastern Cape, 6045, South Africa
Johannesburg Gauteng, 2196, South Africa
Parktown Gauteng, 2196, South Africa
Pretoria Gauteng, 0081, South Africa
Pretoria Gauteng, 0181, South Africa
Cape Town Limpopo, 7700, South Africa
Kraaifontein Western Cape, 7570, South Africa
San Sebastian Gipuzkoa, 20014, Spain
Valencia Valenciana, Comunitat, 46014, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28009, Spain
Sevilla , 41009, Spain
Basel Basel-Stadt, 4031, Switzerland
Bern Berne, 3010, Switzerland
Geneva Geneve, 1211, Switzerland
Chur Grisons, 7000, Switzerland
St. Gallen Sankt Gallen, 9007, Switzerland
Bellinzona Ticino, 6500, Switzerland
Lausanne Vaud, 1011, Switzerland
Sion Wallis, 1951, Switzerland
Zuerich Zurich, 8091, Switzerland
Cambridge Cambridgeshire, CB2 0, United Kingdom
London London, City Of, SE1 9, United Kingdom
London London, City Of, SW3 6, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Manchester , M20 4, United Kingdom
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