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)

Phase 3

Active, not recruiting

Interventions: Biological: Pembrolizumab/Vibostolimab
Biological: Pembrolizumab

Brief 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.

Detailed Description: With Amendment 4, participants will discontinue treatment with pembrolizumab/vibostolimab.

The protocol-specified futility analysis of the primary outcome measure was completed with a data cut-off of 06-Mar-2024 (Primary Completion Date) and served as the final analysis of the primary outcome measure. Per protocol, 192 participants enrolled after the primary completion date and will be analyzed in the End of Trial analysis.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pembrolizumab/Vibostolimab	Pembrolizumab/Vibostolimab	Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).
Pembrolizumab	Pembrolizumab	Participants receive 200 mg pembrolizumab via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 17 cycles (up to \~1 year).

Primary Outcome Measures

Name	Time	Method
Recurrence-Free Survival (RFS)	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 Outcome Measures

Name	Time	Method
Number of Participants Who Experienced at Least One Adverse Event (AE)	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.
Number of Participants Who Discontinued Study Treatment Due to an AE	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.

Locations (205): Moores Cancer Center ( Site 0116)
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La Jolla, California, United States
The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)
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Los Angeles, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)
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Los Angeles, California, United States
California Pacific Medical Center - Pacific Campus ( Site 0111)
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San Francisco, California, United States
UCSF Medical Center at Mission Bay ( Site 0130)
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San Francisco, California, United States
The Melanoma & Skin Cancer Institute ( Site 0120)
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Englewood, Colorado, United States
Georgetown University Medical Center ( Site 0144)
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Washington D.C., District of Columbia, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)
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Miami, Florida, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 0124)
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Tampa, Florida, United States
Northwestern Memorial Hospital ( Site 0109)
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Chicago, Illinois, United States
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Moores Cancer Center ( Site 0116)
🇺🇸La Jolla, California, United States