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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)

Clinical Trial Details

This clinical trial is for men and women who have had surgery to remove their melanoma.
   
The purpose of this study is to test the safety and anti-cancer activity of an experimental treatment called MK-7684A (a combination of MK-7684 and pembrolizumab) compared to pembrolizumab alone in adults who have had surgery to remove their melanoma.
   
MK-7684A is a combination of 2 drugs: MK-7684 and pembrolizumab (pembro). MK-7684 is an experimental drug. It has not been approved by the Food & Drug Administration (FDA). Pembro has been approved by certain health authorities for treating melanoma and other cancers. It has become a standard treatment for melanoma in many countries, though it may not be approved for participants’ exact type of melanoma in all countries.

This trial will compare MK-7684A to pembro alone. The drug a participant gets will depend on which group they are placed in. This trial has 2 groups:

   --Group 1: will get MK-7684A
   --Group 2: will get pembro
   
A computer will decide which group a participant is put in. Participants have an equal chance of being in Group 1 or Group 2.
   
All trial drugs will be given once every 3 weeks by a needle in the arm (intravenous [IV] infusion).
   
The length of participation in the trial depends on a participant’s health and how well they tolerate the trial drugs. Participants will be in the Treatment Phase for about 1 year, as long as their cancer does not get worse, and they tolerate the trial drugs. After the Treatment Phase, participants will be in the Follow-up Phase for approximately 8 years. Follow-up visits will continue until their cancer becomes worse or they start a new cancer treatment. Once participants have completed the follow-up visits, the trial team will contact them every 12 weeks to check on their health.

Key Eligibility: 
  1. Adults with surgically resected and histologically/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. Participants with BRAF-mutated melanoma are eligible to enroll.
  2. Has not received any prior systemic therapy for their melanoma beyond surgical resection.

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Alexa Charney, NP
646) 962-6444
anc4034@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2303025885

ClinicalTrials.gov:

NCT05665595

Sponsor:

MK-7684A-010

Status

Not Yet Recruiting

Age Group

Adult

Sponsor

Disease