CERPASS – A Study of Cemiplimab Given Alone Versus in Combination with the Oncolytic Immunotherapy RP1 to Treat Advanced Cutaneous Squamous Cell Carcinoma

Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04050436

Identifier: NCT04050436

This is a randomized Phase 2 clinical trial to compare the effects of cemiplimab alone versus a combination of cemiplimab and the investigational oncolytic immunotherapy RP1. Researchers will study the effectiveness of these treatments against tumors and how long the effect lasts for.

Who is this study for?

This study is for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC).

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Have locally advanced or metastatic CSCC
• Have at least 1 measurable lesion
• Are at least 18 years old
• Have not been treated with a prior oncolytic immunotherapy or other immune modulating agents
• No active autoimmune disease
• Do not have an active viral infection, including from HSV-1, hepatitis B (HBV), hepatitis C (HCV) or HIV

Please note that there are additional criteria that must be met in order to participate in this study. Consult with your doctor to determine if you are eligible.

What to expect during the study:

There are two randomly assigned groups of patients in this study. Patients in one group will receive cemiplimab alone, and patients in the other group will receive the cemiplimab in combination with RP1. This is a 2:1 randomization, meaning you have a greater likelihood of being assigned to the group receiving both cemiplimab and RP1.

If you are in the group receiving only cemiplimab, you will receive an intravenous (IV) infusion every 3 weeks for about 12 months.

If you are in the group receiving cemiplimab and RP1, you will receive a single dose of RP1 and then every 3 weeks you will receive cemiplimab and RP1 for approximately 8 months. After that, you will receive an IV infusion of cemiplimab every 3 weeks for 4 additional months (12 months total). Patients who benefit from the treatment but have residual disease may also receive up to an additional 8 extra doses of RP1 in combination with cemiplimab.

The study has different sections. They are:

Initial ScreeningUp to 28 days
Treatment PeriodApproximately 12 months
Follow-up PeriodUp to 6 months after the last dose of trial drug
Follow-up Period
Every 3 months for up to 3 years after you start therapy

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Contact Email: clinicaltrials@replimune.com
Contact Phone Number: +1 (781) 222 9570

RP1 and its use in combination with cemiplimab is investigational, has not been proven to be safe and has not been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority.