Fianlimab + Cemiplimab + Ipilimumab for Melanoma
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. However, you cannot be on high-dose systemic steroids or other immunosuppressive medications within 14 days of starting the trial treatment.
What data supports the effectiveness of the drug combination Fianlimab, Cemiplimab, and Ipilimumab for treating melanoma?
Research shows that combining drugs like nivolumab and ipilimumab can significantly improve survival and response rates in advanced melanoma patients compared to using ipilimumab alone. This suggests that combining similar drugs, like Fianlimab, Cemiplimab, and Ipilimumab, might also enhance treatment effectiveness.12345
What safety information is available for the combination of Fianlimab, Cemiplimab, and Ipilimumab in treating melanoma?
Ipilimumab, an immune checkpoint inhibitor, can cause immune-related side effects, which are often mild but can sometimes be severe and life-threatening. These side effects are generally manageable with early recognition and treatment, such as using corticosteroids. Combining ipilimumab with other treatments like anti-PD1 agents has shown increased efficacy but also potential for greater toxicity.678910
What makes the drug combination of Fianlimab, Cemiplimab, and Ipilimumab unique for treating melanoma?
The combination of Fianlimab, Cemiplimab, and Ipilimumab is unique because it targets multiple immune checkpoints to enhance the body's immune response against melanoma, potentially offering a more comprehensive approach compared to treatments using fewer drugs. This combination may provide a novel strategy by incorporating Fianlimab, which is not commonly used in existing melanoma treatments.111121314
What is the purpose of this trial?
The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.
Research Team
James Smithy, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for individuals with advanced melanoma that can't be removed by surgery or has spread, and who haven't responded to other treatments. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous Fianlimab and Cemiplimab every three weeks and Ipilimumab every six weeks continuously
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cemiplimab
- Fianlimab
- Ipilimumab
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School