2022-501966-23-00
Active, not recruiting
Phase 3
Adjuvant Therapy with Pembrolizumab versus Placebo in Resected Highrisk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)
Merck Sharp & Dohme LLC48 sites in 6 countries530 target enrollmentStarted: September 25, 2023Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 530
- Locations
- 48
- Primary Endpoint
- Recurrence-free Survival (RFS)
Overview
Brief Summary
To compare Recurrence-free Survival (RFS) between treatment arms.
Eligibility Criteria
- Ages
- 0 years to 65+ years (65+ Years, 18-64 Years, 0-17 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Is 12 years or older
- •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 Criteria
- •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 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
- •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
Outcomes
Primary Outcomes
Recurrence-free Survival (RFS)
Recurrence-free Survival (RFS)
Secondary Outcomes
- Distant Metastasis-free Survival (DMFS)
- Overall Survival (OS)
- Number of Participants Who Experienced at Least One Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an AE
Investigators
Mizuho Kalabis
Scientific
Merck Sharp & Dohme LLC
Study Sites (48)
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