Study on Cemiplimab Alone and Combined with RP1 for Treating Advanced Squamous Skin Cancer
Sponsor: Replimune Inc.
ClinicalTrials ID:NCT04050436
This clinical trial is testing the effectiveness of cemiplimab alone and in combination with RP1, a modified herpes virus, in treating advanced squamous cell skin cancer. The study aims to compare how well each treatment works in shrinking tumors and achieving complete responses.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the benefits of using cemiplimab by itself versus using it together with RP1, a modified herpes simplex virus, in patients with advanced squamous cell skin cancer. Researchers will measure the success of these treatments by looking at how many patients experience tumor shrinkage and complete disappearance of cancer, as reviewed by independent experts.
Description
RP1 is a specially designed version of the herpes simplex virus type 1 (HSV-1) that can selectively target and replicate in cancer cells. This study is in Phase 1/2 and involves multiple centers. It tests RP1 alone and in combination with another drug, nivolumab, in patients with advanced cancers. The study includes different stages: increasing doses of RP1 alone, expanding to include nivolumab, and testing the combination in various types of tumors during Phase 2.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced squamous cell skin cancer that cannot be treated with surgery or radiation, or have chosen not to undergo these treatments.
- Have at least one tumor that can be measured and injected according to study guidelines.
- Be in good general health with an ECOG performance status of 1 or less. Patients with a status of 2 may be eligible if it is due to the skin cancer being studied.
- Have a life expectancy of more than 12 weeks.
- Agree to provide a tumor sample for review to confirm the diagnosis of squamous cell skin cancer.
Exclusion Criteria
- Have previously received treatment with a virus-based cancer therapy.
- Have active or significant past herpes infections or complications from HSV-1, such as eye or brain infections.
- Need to take anti-viral medications that work against herpes, like acyclovir.
- Have had significant autoimmune diseases in the past 5 years that required treatment with immune-suppressing drugs.
- Have been treated with drugs that block PD-1/PD-L1 pathways or other immune-modulating agents within the last 3 years, except as part of pre-surgery or post-surgery therapy.
- Have untreated brain metastases that are considered active.
- Have active hepatitis B or C, or HIV infection.
- Have a history of lung inflammation or pneumonitis in the last 5 years that required steroid treatment.
- Have had major surgery within 28 days before starting the study.
- Have received live vaccines within 28 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego | 92093 | La Jolla | California |
| University of California Los Angeles | 90024 | Los Angeles | California |
| Stanford University | 94305 | Stanford | California |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| University of Miami Health System | 33136 | Miami | Florida |
| Orlando Health UF Health Cancer Center | 32806 | Orlando | Florida |
| Moffitt McKinley Outpatient Center | 33612 | Tampa | Florida |
| Winship Cancer Institute of Emory University | 30322 | Atlanta | Georgia |
| John Theurer Cancer Center at Hackensack Univeristy Medical Center | 07601 | Hackensack | New Jersey |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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