Pembrolizumab for Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+193 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) who've had surgery and radiotherapy. They must be disease-free post-treatment, not pregnant or breastfeeding, and have a life expectancy over 3 months. Excluded are those with active cancer other than LA cSCC, recent live vaccines, certain prior treatments including anti-PD-1/L1/L2 agents within 4 weeks, unresolved radiation toxicities, autoimmune diseases needing treatment in the past 2 years, or organ transplants.

Inclusion Criteria

I had surgery to remove all visible skin cancer, but some tiny cancer cells might remain.

Is not a woman of childbearing potential (WOCBP)

My cancer is a type of skin cancer that started in the skin cells.

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Exclusion Criteria

Has a known history of human immunodeficiency virus (HIV) infection

I have received a transplant from another person.

I have a type of skin cancer that is not squamous cell carcinoma and it hasn't been fully treated.

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Treatment Details

Interventions

Pembrolizumab (PD-1 Inhibitor)
Placebo (Other)

Trial OverviewThe study tests pembrolizumab against a placebo to see if it can prevent cancer from coming back after surgery and radiation in patients with LA cSCC. Participants will randomly receive either pembrolizumab or a placebo without knowing which one they're getting (double-blind). The main goal is to compare how long each group stays cancer-free.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.

Group II: PlaceboPlacebo Group1 Intervention

Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.