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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

CERPASS Trial 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.Check my eligibility
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.See study design
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.

CERPASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured and treated according to the study.
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I agree to provide samples of my tumor for review.
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My skin cancer is advanced or has spread to other parts.
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I cannot or will not undergo surgery or radiation for my advanced disease.
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I can do all or most of my daily activities despite my cancer.

CERPASS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate (CRR) according to blinded independent review
Objective Response Rate (ORR) according to blinded independent review
Secondary outcome measures
3-year survival
Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Duration of Response (DOR) per investigator review and blinded independent review
+7 more

CERPASS 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
~1340

Find a Location

Who is running the clinical trial?

Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
1,104 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,616 Total Patients Enrolled
Claudia Andreu Vieyra, PhDStudy DirectorLead Medical Monitor

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04050436 — Phase 2
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04050436 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are currently hosting this experiment?

"Currently, there are 27 sites hosting this trial. These locations span from Columbus to Hackensack and Atlanta in addition to other cities. Participants should prioritize the closest location as a means of reducing travel needs if they choose to join the study."

Answered by AI

Is enrollment for this research endeavor still available?

"Affirmative. According to the clinicaltrials.gov website, this study is actively recruiting patients who meet its criteria and has been doing so since October 8th 2019. 180 enrollees are required from 27 different medical sites for the trial that was most recently updated on August 5th 2022."

Answered by AI

Has RP1 been given the stamp of approval by the Food and Drug Administration?

"After careful assessment, RP1's safety was scored a 2. This is because the medication has only been through Phase 2 trials, where some degree of safety could be ascertained but efficacy had yet to be verified."

Answered by AI

What ailment is RP1 commonly prescribed to treat?

"RP1 is typically prescribed to patients with alk gene mutation, but it can also be beneficial for those suffering from advanced directives, malignancies, and metastatic cutaneous squamous cell carcinoma."

Answered by AI

What is the current enrollment number for this medical experiment?

"Replimune Inc. has set the goal of recruiting 180 patients that meet the trial's requirements to participate in their study. The research is scheduled to take place at Ohio State University Comprehensive Cancer Center and John Theurer Cancer Center at Hackensack Univeristy Medical Center, among other sites."

Answered by AI

Have there been any additional studies conducted on the effects of RP1?

"At present, 56 investigations are being conducted into RP1. 4 of these live trials have reached Phase 3 with Barcelona and California the most prominent locations for this research; however a total of 1738 sites around the world are running studies on this pharmaceutical treatment."

Answered by AI
~53 spots leftby Sep 2025