Adjuvant MK-7684A Versus Adjuvant Pembrolizumab in High-Risk Stage II-IV Melanoma

Summary

The purpose of this study is to evaluate an experimental drug called MK-7684A in adults and children who have had surgery to remove their melanoma. MK-7684A, a type of immunotherapy, is given as a combination of 2 drugs: MK-7684 and pembrolizumab (pembro). Immunotherapies stimulate the body’s own immune system to fight cancer. Pembro has become a standard treatment for melanoma in many countries. This study will compare MK-7684A with pembro to pembro alone. Specifically, researchers will examine the safety and effectiveness of MK-7684A compared to pembro, in addition to investigating whether participants who receive MK-7684A in combination with pembro live longer and have a better quality of life compared to those who receive pembro only. Participants will be randomly assigned to 1 of 2 groups. One group will receive MK-7684, and the other will receive pembro.

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)

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

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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

Full Title

MK7684A-010-00: A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A Versus Adjuvant Pembrolizumab in Participants with High-risk Stage II-IV Melanoma

Details

Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Justin Moyers, Kristopher Wentzel, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

III

IRB Number

STUDY00002465

ClinicalTrials.gov ID

NCT05665595

Key Eligibility

ClinicalTrials.gov

Contact

cancer.trial.info@cshs.org

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