Fianlimab + Cemiplimab for Melanoma

CF
Uo
Overseen ByUniversity of California Irvine Medical
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, Irvine
Must be taking: Antiretrovirals
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

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?

WC

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

Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment.
Life expectancy of at least 12 weeks.
Females of childbearing potential and males must be willing and able to use a highly effective method of contraception to avoid pregnancy for the duration of the study and for at least 6 months after the last dose of study treatment. Acceptable means of contraception are listed in the fianlimab institutional brochure.
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Exclusion Criteria

Participants must not have any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.
I have been diagnosed with acral, ocular, or mucosal melanoma.
Known hypersensitivity to the active substances or to any of the excipients.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant Fianlimab in combination with Cemiplimab every 3 weeks

9-24 weeks
3-8 visits (in-person)

Surgery

Participants undergo surgery to remove their cancer

Adjuvant Treatment

Participants receive adjuvant Fianlimab in combination with Cemiplimab every 3 weeks

9-39 weeks
3-13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 months

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

Group I: 8 doses of neoadjuvant Fianlimab in combination with CemiplimabExperimental Treatment2 Interventions
Group II: 6 doses of neoadjuvant Fianlimab in combination with CemiplimabExperimental Treatment2 Interventions
Group III: 3 doses of neoadjuvant of Fianlimab in combination with CemiplimabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials
580
Recruited
4,943,000+

UC Cancer Consortium

Collaborator

Citations

Clinical 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 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38900987/

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 ...

Fianlimab 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- ...