Cemiplimab + RP1 for Advanced Squamous Skin Cancer
(CERPASS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you need to use certain antiviral medications or have had specific treatments like PD-1/PD-L1 blockers. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Cemiplimab for advanced squamous skin cancer?
Cemiplimab has been shown to be effective in treating advanced cutaneous squamous cell carcinoma, with studies indicating it improves survival and has substantial antitumor activity. It is approved by the FDA for patients who cannot undergo surgery or radiation, and it has demonstrated benefits over other treatments like EGFR inhibitors and chemotherapy.12345
Is the combination of Cemiplimab and RP1 safe for treating advanced squamous skin cancer?
Cemiplimab, also known as Libtayo, has been shown to be generally safe in humans, with most side effects being manageable. Common side effects include fatigue, diarrhea, itching, and rash, while severe side effects are rare and include inflammation of the lungs, heart, muscles, and liver. The risk of treatment-related death is low, at about 3% in clinical trials.12678
What makes the drug cemiplimab unique for treating advanced squamous skin cancer?
Cemiplimab is unique because it is the first approved drug specifically for advanced cutaneous squamous cell carcinoma, working by blocking a protein called PD-1 to help the immune system attack cancer cells. It is administered intravenously and has shown significant and durable responses in patients who cannot undergo surgery or radiation.12679
What is the purpose of this trial?
To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.
Research Team
Moran Mishal, MD
Principal Investigator
Lead Medical Monitor
Jeannie Hou, MD
Principal Investigator
Secondary Medical Monitor
Eligibility Criteria
This trial is for adults with advanced squamous skin cancer who can't have or don't want surgery/radiotherapy. They should be relatively active (ECOG ≤1), expected to live more than 12 weeks, and able to provide a tumor sample. Not allowed if they've had certain previous treatments, active brain metastases, lung inflammation in the last 5 years, recent vaccines, herpes complications, need anti-herpetic drugs regularly, significant autoimmune disease treated with immunosuppressants within 5 years, or have hepatitis B/C or HIV.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cemiplimab monotherapy or cemiplimab in combination with RP1, administered every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cemiplimab
- RP1
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Replimune Inc.
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School