Actively Recruiting
A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14
88
Participants Needed
12
Research Sites
155 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Able to provide informed consent personally or via a legal representative
- Histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma that progressed on PD-1/PD-L1 therapy
- For Cohort A: progression after prior PD-1 monotherapy
- For Cohort B: progression after prior combination PD-1 and LAG-3 blockade
- Previous targeted therapy, chemotherapy, bispecific or cell-based therapies allowed between last immune checkpoint inhibitor therapy and study start
- Peptide and mRNA vaccines allowed if no other checkpoint inhibitors were given concurrently
- Documented progression within 3 months of last neoadjuvant or adjuvant PD-1 or PD-1 + LAG-3 therapy dose
- Measurable disease by RECIST v1.1 criteria
- Willingness to submit suitable archival tissue samples or undergo biopsy if safe
- ECOG performance status of 0 or 1
- Adequate laboratory function: hemoglobin ≥ 10 gm/dL, platelet count ≥ 100 x 10^9/L, bilirubin ≤ 1.5 x ULN (total bilirubin < 3 mg/dL for Gilbert's disease), AST and ALT ≤ 2.5 x ULN
- No signs of active coronary ischemia
- Creatinine clearance ≥ 30 mL/min
- All immune-related adverse events from prior checkpoint inhibitor therapy resolved to Grade 1 or less, except stable adrenal insufficiency on ≤ 7.5 mg prednisone equivalent daily
- Women of childbearing potential and sexually active men must use highly effective contraception during and for 6 months after study
- Male participants with partners of childbearing potential must use condoms unless vasectomized or practicing sexual abstinence
- Definitions and contraceptive methods as per Clinical Trial Facilitation Group guidance
You will not qualify if you...
- Diagnosis of uveal melanoma
- Untreated central nervous system metastases or leptomeningeal involvement; treated brain metastases allowed if definitively managed by surgery or stereotactic radiosurgery
- For Cohort A: prior anti-LAG-3 or CTLA-4 therapy unless given in adjuvant/neoadjuvant setting more than 3 months before recurrence
- For Cohort B: prior CTLA-4 therapy unless given in adjuvant/neoadjuvant setting more than 3 months before recurrence
- Prior Grade 3 or higher neurologic toxicity from immune checkpoint inhibitor therapy
- Prior myocarditis related to immune checkpoint inhibitor therapy
- Prior Grade 3 or higher colitis or enteritis requiring hospitalization
- Systemic steroids above physiologic doses (>7.5 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before treatment start; inhaled or topical steroids allowed if no active autoimmune disease
- Live vaccine within 30 days before starting study medication
- Significant infection requiring systemic antibiotics within 2 weeks before study medication start
- Uncontrolled or unstable medical conditions or organ dysfunction compromising safety or compliance
- Other active malignancies requiring systemic treatment or interfering with melanoma assessment
- History of severe allergic reactions to study drugs or their components
- Uncontrolled HIV, hepatitis B or C infections, or diagnosed immunodeficiency; controlled infections allowed with monitoring
- Pregnant or breastfeeding women
- Prisoners or involuntarily incarcerated individuals
- Participants compulsorily detained for psychiatric or physical illness treatment
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Stanford University (Data Collection Only)
Stanford, California, United States, 94305
Actively Recruiting
3
Hartford Healthcare Alliance (Data Collection Only)
Hartford, Connecticut, United States, 06102
Actively Recruiting
4
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
5
Hackensack Meridian Health (Data Collection Only)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
7
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
8
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
9
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
11
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
12
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
J
James Smithy, MD
CONTACT
M
Michael Postow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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