Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT07527325
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Melanoma (Skin)

Eligibility Criteria

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

Interventions

Study Details

This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2029
Completion
Feb 1, 2030

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3 doses of neoadjuvant of Fianlimab in combination with Cemiplimab
    3 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 13 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks
  • Experimental: 6 doses of neoadjuvant Fianlimab in combination with Cemiplimab
    6 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 10 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks
  • Experimental: 8 doses of neoadjuvant Fianlimab in combination with Cemiplimab
    8 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 8 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Primary Outcome Measure

Major Pathologic Response (MPR) Rate by RECIST v1.1 [ Time Frame: 16 months ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center University of California, IrvineOrangeCalifornia92868-

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By research site
Chao Family Comprehensive Cancer Center University of California, Irvine· Orange, CA

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