Fianlimab + Cemiplimab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two drugs, Fianlimab and Cemiplimab, in treating melanoma (a type of skin cancer) before and after surgery. Researchers aim to determine if these drugs can reduce the cancer more effectively. Participants will receive varying doses of the drug combination before surgery and continue treatment afterward. Suitable candidates for this trial have melanoma that can be surgically removed and experience symptoms such as visible skin changes or growths. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found the combination of Fianlimab and Cemiplimab to be safe for people with melanoma, a type of skin cancer. Research shows that the side effects resemble those of other treatments targeting PD-1, a protein that helps control the immune system. This indicates that patients generally tolerate the treatment well. Some individuals may experience side effects, but these typically align with expectations for this kind of therapy.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about Fianlimab and Cemiplimab for melanoma because they combine two powerful immunotherapies that work together to supercharge the immune system. Unlike traditional treatments like surgery, chemotherapy, or radiation, these drugs specifically target and block proteins that normally hold back the immune system's attack on cancer cells. This combination approach has the potential to be more effective in shrinking tumors before surgery and preventing their return, offering new hope for patients with melanoma.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research has shown that combining Fianlimab and Cemiplimab yields promising results for treating melanoma. In earlier studies, 61.2% of patients experienced tumor reduction or disappearance, with some showing strong and lasting improvements. Another study found that 63% of patients with advanced melanoma responded to this treatment, with some achieving no detectable cancer. In this trial, participants will receive various dosing regimens of Fianlimab and Cemiplimab together, which could effectively treat melanoma.12367
Who Is on the Research Team?
Warren Chow, MD
Principal Investigator
Chao Family Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with certain types of advanced skin melanoma that can be removed by surgery. Participants must have good organ function, not be pregnant or breastfeeding, and agree to use contraception. People with some other cancers, serious infections, autoimmune diseases needing treatment, or brain/bone/visceral metastases cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant Fianlimab in combination with Cemiplimab every 3 weeks
Surgery
Participants undergo surgery to remove their cancer
Adjuvant Treatment
Participants receive adjuvant Fianlimab in combination with Cemiplimab every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- Fianlimab
Trial Overview
The study tests a combination of two drugs—Fianlimab and Cemiplimab—given before surgery to see how well they work together in treating resectable melanoma. All participants receive both drugs; there is no placebo group.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
8 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 8 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks
6 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 10 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks
3 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 13 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
UC Cancer Consortium
Collaborator
Citations
1.
curemelanoma.org
curemelanoma.org/blog/clinical-trials-testing-combination-immunotherapy-for-high-risk-and-advanced-melanoma-regenerons-lag-3-programClinical Trials Testing Combination Immunotherapy for ...
Results showed that 43% of patients who received the nivolumab + relatlimab combination responded to the treatment. The combination of nivolumab ...
NCT05352672 | Clinical Study of Fianlimab in Combination ...
The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a ...
Phase I Study of Fianlimab, a Human Lymphocyte ...
Conclusion: The current results show a promising benefit-risk profile of fianlimab/cemiplimab combination for patients with advanced melanoma, ...
A phase 1 study of fianlimab (anti-LAG-3) in combination ...
Conclusions: The combination of fianlimab and cemiplimab showed high activity in pts with advanced Mel and poor prognosis features at BL. The ...
5.
targetedonc.com
targetedonc.com/view/fianlimab-plus-cemiplimab-shows-efficacy-in-pd-1-pretreated-metastatic-melanomaFianlimab Plus Cemiplimab Shows Efficacy in PD-1– ...
The objective response rate (ORR) for fianlimab/cemiplimab was 61.2% in all patients, 60.9% in patients with any adjuvant treatment, and 61.5% ...
A Phase 3 trial of fixed-dose combination of fianlimab + ...
Here, we explore the efficacy and safety profile of fianlimab + cemiplimab versus relatlimab (anti–LAG-3) + nivolumab (anti–PD-1) in pts with melanoma.
A phase 1 study of fianlimab (anti–LAG-3) in combination ...
Conclusions: Fianlimab + cemiplimab in pts with HNSCC showed signs of clinical activity with durable responses among pts with anti–PD-1/PD-L1- ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.