Actively Recruiting
A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-14
88
Participants Needed
12
Research Sites
N/A
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
Researchers are evaluating a combination treatment of fianlimab, cemiplimab, and ipilimumab for people with locally advanced or metastatic melanoma that cannot be removed surgically and has not responded to prior therapies blocking PD-1 or PD-L1. This phase 2 study aims to determine whether this combination is safe and causes only mild or few side effects in those with refractory melanoma. All participants will receive intravenous fianlimab and cemiplimab every three weeks without interruption. Ipilimumab will be given intravenously every six weeks continuously. Initially, fianlimab and cemiplimab are given together, followed by ipilimumab on the first day of each treatment cycle according to institutional practices. The study includes two groups based on the type of prior therapy patients received: one group with progression after PD-1 monotherapy and another group after combined PD-1 and LAG-3 blockade. Participants will undergo regular assessments including measuring tumor response every six weeks to determine the treatment effect. Researchers will monitor safety and side effects throughout the study. Participants must have measurable disease and meet specific health criteria before enrollment. The total duration of participation will depend on individual response and ongoing treatment needs, with safety and disease progression being closely followed by the research team.
CONDITIONS
Brief 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
- Ability of patient or legal representative to provide informed consent
- Histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma
- Progression on prior PD-1 monotherapy for Cohort A or on prior combined PD-1 and LAG-3 blockade for Cohort B
- Measurable disease as defined by RECIST v1.1
- Willingness to submit suitable archival tissue sample if available or undergo biopsy if safe
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate laboratory function including hemoglobin ≥ 10 gm/dL, platelet count ≥ 100 x 10^9/L, and liver enzymes within specified limits
- No signs of active coronary ischemia
- Calculated creatinine clearance ≥ 30 mL/min
- Immune-related adverse events from prior therapy improved to Grade 1 or lower, or stable adrenal insufficiency on low-dose steroid replacement
- Use of highly effective contraception for women of childbearing potential and sexually active men during and up to 6 months after treatment
You will not qualify if you...
- Diagnosis of uveal melanoma
- Untreated central nervous system metastases or leptomeningeal involvement
- Prior anti-LAG-3 or CTLA-4 therapy for Cohort A unless given over 3 months before recurrence
- Prior CTLA-4 therapy for Cohort B unless given over 3 months before recurrence
- Prior Grade 3 or higher neurologic toxicity from immune checkpoint inhibitors
- Prior myocarditis linked to immune checkpoint inhibitor therapy
- Prior Grade 3 or higher colitis or enteritis requiring hospitalization
- Use of systemic steroids above physiologic replacement or other immunosuppressive drugs within 14 days before treatment
- Receipt of live vaccine within 30 days before study medication
- Significant infection requiring antibiotics within 2 weeks before study medication
- Uncontrolled medical conditions that could affect safety or compliance
- Other active cancers needing systemic treatment or interfering with melanoma assessment
- History of severe allergic reactions to study drug components
- Uncontrolled HIV, hepatitis B or C infections, or immunodeficiency
- Pregnant or breastfeeding women
- Prisoners or involuntarily incarcerated individuals
- Participants compulsorily detained for psychiatric or physical illness treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing treatment with dosing every 3 to 6 weeks until disease progression or discontinuation
Participants receive intravenous Fianlimab and Cemiplimab every three weeks continuously, with Ipilimumab given every six weeks continuously. Fianlimab and Cemiplimab are initially co-administered, followed by Ipilimumab on Day 1 of each cycle according to institutional standards.
Visits every 3 weeks for Fianlimab and Cemiplimab infusions and every 6 weeks for Ipilimumab infusion
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
M
Michael Postow, MD
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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