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
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Phase
Phase 3
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Recruitment status
Terminated
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Participants
1,594
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2023-01-19
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Number of sites
205
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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.
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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)
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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)
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 3
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Study type
Interventional
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Reason stopped
Business Reason
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Completion date
2025-09-26
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First posted
2022-12-27
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Registry last updated
2026-08-18
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Primary completion date
2024-03-06
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Start date
2023-01-19
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Actual participants
1,594
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Participants
1,594
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
205
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05665595
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ClinicalTrials.gov ID
NCT05665595
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
12 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • MK-7684A-010
  • U1111-1280-3661
  • jRCT2031230099
  • 2022-501417-31-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)