Pembrolizumab for High-risk Stage II Melanoma

Recruiting in Palo Alto (17 mi)

+158 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/\~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

Eligibility Criteria

This trial is for individuals with a new diagnosis of high-risk Stage II melanoma that's been surgically removed. They haven't had other melanoma treatments, are within 12 weeks post-surgery, and show no metastasis. Participants must be in good physical condition (ECOG score 0 or 1) and not pregnant or breastfeeding, agreeing to use contraception.

Inclusion Criteria

I have only had surgery for my melanoma, no other treatments.

It has been less than 12 weeks since my last surgery.

I am mostly active and can carry out daily activities without significant help.

+4 more

Exclusion Criteria

I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

+14 more

Participant Groups

The study tests pembrolizumab against a placebo in people who've had high-risk Stage II melanoma surgery. It's double-blind at first: patients get either the drug or placebo every three weeks for about a year. If the cancer returns, they can get more pembrolizumab openly for up to two years.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

Group II: PlaceboPlacebo Group2 Interventions

Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

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

🇺🇸 Approved in United States as KEYTRUDA for: