A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06594991
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fianlimab — DRUG
    Fianlimab IV given every three weeks
  • Cemiplimab — DRUG
    Cemiplimab IV given every three weeks
  • Ipilimumab — DRUG
    Ipilimumab will be give every 6 weeks continuously

Study Details

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.

Key Dates

Start date
Sep 10, 2024
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Refractory melanoma after PD-1 monotherapy (Cohort A)
    All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously. For all patients, fianlimab and Ccemiplimab will initially be co-administered and then followed by ipilimumab on D1 of each cycle per institutional standards.
  • Experimental: Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B)
    All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously. For all patients, fianlimab and Ccemiplimab will initially be co-administered and then followed by ipilimumab on D1 of each cycle per institutional standards.

Primary Outcome Measure

Determine best objective response rate (ORR) (cohort A) [ Time Frame: 6 weeks ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Inderjit Mehmi, MD
310-231-2121
Stanford University (Data Collection Only)StanfordCalifornia94305
Allison Betof Warner, MD, PhD
650-724-9707
Hartford Healthcare Alliance (Data Collection Only)HartfordConnecticut06102
Jaykumar Thumar, MD
860-676-7000
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
James Smithy, MD
646-888-6782
Hackensack Meridian Health (Data Collection Only)HackensackNew Jersey07601
Andrew Pecora, MD
844-346-7222
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
James Smithy, MD
646-888-6782
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
James Smithy, MD
646-888-6782
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
James Smithy, MD
646-888-6782
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
James Smithy, MD
646-888-6782
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
James Smithy, MD
646-888-6782
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
James Smithy, MD
646-888-6782
MD Anderson Cancer Center (Data Collection Only)HoustonTexas77030
Hussein Tawbi, MD, PhD
855-701-7200

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAStanford University (Data Collection Only)· Stanford, CAHartford Healthcare Alliance (Data Collection Only)· Hartford, CTMemorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJHackensack Meridian Health (Data Collection Only)· Hackensack, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJ

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