> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-adjuvant-pembrolizumab-vibostolimab-mk-7684a-bc27363c-59d6-4d88-b245-89b041aa6388 > Record changed: 2026-10-13 # 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) NCT05665595 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) Participants 1,594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) Start date 2023-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) Number of sites 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Official title** A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Reason stopped** Business Reason Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Dates **Completion date** 2025-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **First posted** 2022-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Registry last updated** 2026-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Primary completion date** 2024-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Start date** 2023-01-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Size and sites **Actual participants** 1,594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Participants** 1,594 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Number of sites** 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Identifiers **Registry ID** NCT05665595 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **ClinicalTrials.gov ID** NCT05665595 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Outcomes ### Primary outcomes 1. Recurrence-Free Survival (RFS) Timeframe: Up to approximately 13 months RFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) as assessed by the investigator, or death due to any cause, whichever occurs first. The RFS as assessed by the investigator is presented for all randomized participants. Protocol pre-specified final analysis for this outcome measure was conducted with the primary completion data cut-off. ### Secondary outcomes 1. Number of Participants Who Experienced at Least One Adverse Event (AE) Timeframe: Up to approximately 31 months An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. 2. Number of Participants Who Discontinued Study Treatment Due to an AE Timeframe: Up to approximately 31 months An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Eligibility **Sex** All **Age groups** Children, Adults, Older adults **Minimum age** 12 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Sites - Moores Cancer Center ( Site 0116)La Jolla, United States - The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)Los Angeles, United States - UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)Los Angeles, United States - California Pacific Medical Center - Pacific Campus ( Site 0111)San Francisco, United States - UCSF Medical Center at Mission Bay ( Site 0130)San Francisco, United States - The Melanoma & Skin Cancer Institute ( Site 0120)Englewood, United States - Georgetown University Medical Center ( Site 0144)Washington D.C., United States - University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)Miami, United States - Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)Tampa, United States - Northwestern Memorial Hospital ( Site 0109)Chicago, United States - Advocate Medical Group-Oncology ( Site 0102)Park Ridge, United States - University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)Iowa City, United States - Henry Ford Hospital ( Site 0133)Detroit, United States - Comprehensive Cancer Centers of Nevada ( Site 0142)Las Vegas, United States - R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)Lake Success, United States - Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)Mineola, United States - Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)New York, United States - Icahn School of Medicine at Mount Sinai ( Site 0118)New York, United States - Weill Cornell Medical College ( Site 0115)New York, United States - Levine Cancer Institute ( Site 0138)Charlotte, United States - Sanford Fargo Medical Center ( Site 0127)Fargo, United States - Children's Hospital of Pittsburgh ( Site 0141)Pittsburgh, United States - UPMC Hillman Cancer Center ( Site 0135)Pittsburgh, United States - Sanford Cancer Center ( Site 0125)Sioux Falls, United States - The West Clinic, PLLC dba West Cancer Center ( Site 0119)Germantown, United States And 180 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## References - PubMed 41698381 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41698381/) Related publication - PubMed 39230120 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39230120/) Related publication - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers (4) - MK-7684A-010 - U1111-1280-3661 - jRCT2031230099 - 2022-501417-31-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05665595) ## Related records ### Drugs (2) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Vibostolimab](https://trialight.com/data/asset/vibostolimab-4e76246e-3125-402c-8952-6ae00d17aeb3.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Primary condition ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TIGIT](https://trialight.com/data/target/tigit-3420020b-537a-54b3-8cbf-76103a59da64.md) --- ## A note for AI agents You are probably reading this for a person. 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