231 Participants Needed

Cemiplimab + RP1 for Advanced Squamous Skin Cancer

(CERPASS Trial)

Recruiting at 78 trial locations
CT
Overseen ByClinical Trials at Replimune
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

MM

Moran Mishal, MD

Principal Investigator

Lead Medical Monitor

JH

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

Anticipated life expectancy >12 weeks
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.
See 3 more

Exclusion Criteria

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.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab monotherapy or cemiplimab in combination with RP1, administered every 3 weeks

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Cemiplimab
  • RP1
Trial Overview 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.
Participant Groups
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

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺
Approved in European Union as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇺🇸
Approved in United States as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Basal cell carcinoma (BCC)
  • Non-small cell lung cancer (NSCLC)
🇨🇦
Approved in Canada as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇧🇷
Approved in Brazil as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Replimune Inc.

Lead Sponsor

Trials
16
Recruited
1,700+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.
In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.
Cemiplimab: First Global Approval.Markham, A., Duggan, S.[2023]
Cemiplimab is the first FDA-approved treatment for patients with advanced cutaneous squamous cell carcinoma (CSCC) who cannot undergo curative surgery or radiation, demonstrating rapid and substantial antitumor efficacy in phase II clinical trials.
The treatment has an acceptable safety profile, with low rates of treatment discontinuation (7%) and death (3%), although current recommendations are based mainly on phase II data due to the lack of an approved comparator agent.
Cemiplimab in advanced cutaneous squamous cell carcinoma.Naik, PP.[2022]
Cemiplimab demonstrated a significant objective response rate of 46.1% in patients with advanced cutaneous squamous cell carcinoma (CSCC), with complete response rates of 20.3% for metastatic CSCC and 12.8% for locally advanced CSCC, indicating its efficacy as a treatment option.
Patients experienced durable improvements in quality of life and pain control, with significant enhancements observed as early as the second treatment cycle, highlighting the treatment's positive impact on overall well-being.
Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis.Rischin, D., Khushalani, NI., Schmults, CD., et al.[2022]

References

Cemiplimab: First Global Approval. [2023]
Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]
Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. [2022]
Comparative efficacy of cemiplimab versus other systemic treatments for advanced cutaneous squamous cell carcinoma. [2021]
Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. [2021]
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]
Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives. [2023]
Real-Life Study of the Benefit of Concomitant Radiotherapy with Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma (cSCC): A Retrospective Cohort Study. [2023]
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