Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
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.
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Exclusion:
Baltimore, Maryland 21287, United States
Cincinnati, Ohio 45219, United States
Knoxville, Tennessee 37920, United States
Wilrijk - Antwerpen, Antwerpen 2610, Belgium
Brussels, Bruxelles-Capitale, Region de 1200, Belgium
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Sao Jose Do Rio Preto - SP, São Paulo 15090-000, Brazil
Essen, North Rhine-Westphalia 45147, Germany
Kiel, Schleswig-Holstein 24105, Germany
Meldola, Forli-Cesena 47014, Italy
Poznan, Greater Poland Voivodeship 60-780, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Bielsko-Biala, Silesian Voivodeship 43-300, Poland
Katowice, Silesian Voivodeship 40-514, Poland
Port Elizabeth, Eastern Cape 6045, South Africa
Cape Town, Limpopo 7700, South Africa
Donostia / San Sebastian, Gipuzkoa 20014, Spain
Bellinzona, Canton Ticino 6500, Switzerland
London, London, City of SW3 6JJ, United Kingdom