Pembrolizumab + Other Agents for Melanoma

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Stay on Your Current Meds

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.

Eligibility Criteria

This trial is for adults with Stage III melanoma suitable for pre-surgery (neoadjuvant) therapy. They must not be pregnant, breastfeeding, or planning to conceive; agree to use contraception; have good organ function; and no recent immunosuppressive treatments or active infections. Prior treatment for melanoma is limited to surgery or radiotherapy on the primary tumor.

Inclusion Criteria

I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.

My organs are functioning well.

My melanoma diagnosis was confirmed through lab tests.

+8 more

Exclusion Criteria

I have not had a live vaccine in the last 30 days.

I have an immune system disorder or have been on immune-weakening medication recently.

My cancer has spread to my brain or the membranes around my brain.

+16 more

Participant Groups

The study tests Pembrolizumab alone or combined with other agents (Vibostolimab, Gebasaxturev, MK-4830, Favezelimab, ATRA) in different groups of participants. The aim is to find which combination works better than current treatments by comparing safety and effectiveness before surgery.

6Treatment groups

Experimental Treatment

Group I: Pembrolizumab + all-trans retinoic acid (ATRA)Experimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus ATRA orally at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group II: Pembrolizumab + VibostolimabExperimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group III: Pembrolizumab + MK-4830Experimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus MK-4830 IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group IV: Pembrolizumab + GebasaxturevExperimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus gebasaxturev (V937) intratumorally (IT) at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group V: PembrolizumabExperimental Treatment1 Intervention

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group VI: Favezelimab + PembrolizumabExperimental Treatment1 Intervention

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive MK-4280A (favezelimab and pembrolizumab administered as a co-formulation) IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

ATRA is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tretinoin for: