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)
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)
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.
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.
Melanoma
Phase III
Both
Mol. targeted/Immunotherapy/Biologics
Not Available
Johnson, Douglas
International
Vanderbilt University
02-28-2024
Eligibility
12 Years
BOTH
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
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
