Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma

What is the Purpose of this Study?

The purpose of this study is to determine whether the drug combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment for refractory melanoma. The study focuses on people whose melanoma has spread or whose melanoma cannot be removed with surgery (unresectable). Fianlimab is a drug called a monoclonal antibody that targets a protein found on immune cells to regulate their function. By blocking a protein called lymphocyte activation gene-3 protein (LAG-3), fianlimab may help slow or stop the growth of cancer. Cemiplimab is a type of drug called a monoclonal anti-PD1 antibody. PD-1 is a protein that acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so the immune system can target cancer cells and destroy them. Ipilimumab is an immunotherapy drug that boosts the body’s natural defenses to fight cancer. It is a type of drug called a CTLA-4 inhibitor. By blocking the CTLA-4 protein, ipilimumab may help slow or stop the growth of cancer. Because these drugs work in different ways, researchers believe their combination may be more effective than any of the 3 drugs given alone. All study participants will receive fianlimab, cemiplimab, and ipilimumab. The use of fianlimab, cemiplimab, and ipilimumab as a combination in this study is considered experimental.


Eligibility

  • * Age ≥ 18 years at the time of informed consent
  • * Patient/legal authorized representative (LAR) must be able to provide informed consent.
  • * Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma that has progressed on PD-1/PD-L1 therapy:
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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

What is the full name of this clinical trial?

24-166 A: A phase 2 study of fianlimab, cemiplimab, and ipilimumab in anti-PD-1 refractory melanoma

Study Details
Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Cathie T Chung, Iryna Singh, Justin Moyers, Kristopher Wentzel, Navid Hafez, Omid Hamid, Vi K. Chiu

Age Group

Adult

Phase

II (Cancer Prevention)

IRB Number

STUDY00003838

ClinicalTrials.gov ID

NCT06594991

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Melanoma

Principal Investigator

Mehmi, Inderjit

Age Group

Adult

Phase

II (Cancer Prevention)

IRB Number

24-166A

ClinicalTrials.gov ID

NCT06594991

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org