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Monoclonal Antibodies
Cemiplimab + RP1 for Advanced Squamous Skin Cancer (CERPASS Trial)
Phase 2
Waitlist Available
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 lesion that is measurable and injectable by study criteria
All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.
Must not have
Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection
Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if cemiplimab monotherapy is better than cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC.
Who is the study for?
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.
What is being tested?
The study compares two approaches: Cemiplimab alone versus combined with RP1 in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). The main focus is on how well these treatments shrink tumors according to independent reviews.
What are the potential side effects?
Possible side effects include immune-related reactions that could affect various organs like the lungs and liver; infusion reactions; fatigue; skin issues; potential worsening of infections including herpes due to immune system changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one tumor that can be measured and treated according to the study.
Select...
I agree to provide samples of my tumor for review.
Select...
My skin cancer is advanced or has spread to other parts.
Select...
I cannot or will not undergo surgery or radiation for my advanced disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have active hepatitis B, hepatitis C, or HIV.
Select...
I have had serious herpes infections or complications like eye or brain infections.
Select...
I have untreated brain tumors that are active.
Select...
I have had lung inflammation or pneumonitis in the last 5 years or needed steroids for it.
Select...
I have been treated with a PD-1/PD-L1 inhibitor before.
Select...
I have been treated with a virus-based cancer therapy before.
Select...
I have not had any major surgery in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cemiplimab in combination with RP1Experimental Treatment2 Interventions
Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
Group II: CemiplimabActive Control1 Intervention
Cemiplimab administered intravenously as a single therapy every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
Replimune Inc.Lead Sponsor
13 Previous Clinical Trials
1,379 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
667 Previous Clinical Trials
385,782 Total Patients Enrolled
Claudia Andreu Vieyra, PhDStudy DirectorLead Medical Monitor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least one tumor that can be measured and treated according to the study.I agree to provide samples of my tumor for review.I haven't had immune therapy for my condition in the last 3 years, except as part of initial treatment.I do not have active hepatitis B, hepatitis C, or HIV.I have had serious herpes infections or complications like eye or brain infections.I need regular anti-herpes medication.I have not received any live vaccines in the last 28 days.My skin cancer is advanced or has spread to other parts.I cannot or will not undergo surgery or radiation for my advanced disease.I have untreated brain tumors that are active.I can do all or most of my daily activities despite my cancer.I have an autoimmune disease treated with immunosuppressants in the last 5 years.I have had lung inflammation or pneumonitis in the last 5 years or needed steroids for it.I have been treated with a PD-1/PD-L1 inhibitor before.I have been treated with a virus-based cancer therapy before.I have not had any major surgery in the last 28 days.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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