A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Completed · Phase 3

Conditions studied: Melanoma

In brief

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Key facts

Study ID

NCT05665595

Run by

Merck Sharp & Dohme LLC

People needed

1594

Starts

2023-01-19

Expected to finish

2025-09-26

Last updated by the study team

2025-10-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
• Has not received any prior systemic therapy for melanoma beyond surgical resection
• Has had no more than 12 weeks between final surgical resection and randomization
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

You may not qualify if…

• Has ocular, mucosal, or conjunctival melanoma
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
• Has not adequately recovered from major surgical procedure or has ongoing surgical complications
• Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
• Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
• Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has an active infection requiring systemic therapy
• Has had an allogenic tissue/solid organ transplant

Where it is running

• The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123) — Los Angeles, California, United States
• UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131) — Los Angeles, California, United States
• California Pacific Medical Center - Pacific Campus ( Site 0111) — San Francisco, California, United States
• UCSF Medical Center at Mission Bay ( Site 0130) — San Francisco, California, United States
• The Melanoma & Skin Cancer Institute ( Site 0120) — Englewood, Colorado, United States
• Georgetown University Medical Center ( Site 0144) — Washington D.C., District of Columbia, United States
• University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110) — Miami, Florida, United States
• Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124) — Tampa, Florida, United States
• Northwestern Memorial Hospital ( Site 0109) — Chicago, Illinois, United States
• Advocate Medical Group-Oncology ( Site 0102) — Park Ridge, Illinois, United States
• University of Iowa-Holden Comprehensive Cancer Center ( Site 0107) — Iowa City, Iowa, United States
• Henry Ford Hospital ( Site 0133) — Detroit, Michigan, United States
• Comprehensive Cancer Centers of Nevada ( Site 0142) — Las Vegas, Nevada, United States
• R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132) — Lake Success, New York, United States
• Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146) — Mineola, New York, United States
• Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113) — New York, New York, United States
• Icahn School of Medicine at Mount Sinai ( Site 0118) — New York, New York, United States
• Weill Cornell Medical College ( Site 0115) — New York, New York, United States
• Levine Cancer Institute ( Site 0138) — Charlotte, North Carolina, United States
• Sanford Fargo Medical Center ( Site 0127) — Fargo, North Dakota, United States
• Children's Hospital of Pittsburgh ( Site 0141) — Pittsburgh, Pennsylvania, United States
• UPMC Hillman Cancer Center ( Site 0135) — Pittsburgh, Pennsylvania, United States
• Sanford Cancer Center ( Site 0125) — Sioux Falls, South Dakota, United States
• The West Clinic, PLLC dba West Cancer Center ( Site 0119) — Germantown, Tennessee, United States
• Moores Cancer Center ( Site 0116) — La Jolla, California, United States

Full record on ClinicalTrials.gov

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