Pembrolizumab for Squamous Cell Carcinoma
What You Need to Know Before You Apply
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).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have received certain cancer therapies or live vaccines recently, you may not be eligible to participate.
Is pembrolizumab safe for humans?
How does the drug pembrolizumab differ from other treatments for squamous cell carcinoma?
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab or placebo by IV infusion every 42 days for up to 9 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may receive up to 18 additional cycles of pembrolizumab if they experience biopsy-proven-disease recurrence
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University