Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Immunocore Ltd
Study ID
NCT03070392
Phase
PHASE2
Status
Completed

Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • IMCgp100 — BIOLOGICAL
    IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity
  • Dacarbazine — DRUG
    Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity
  • Ipilimumab — BIOLOGICAL
    Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity

Study Details

To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Key Dates

Start date
Oct 16, 2017
Status verified
Mar 2026
Primary completion
Oct 13, 2020
Completion
Sep 17, 2025

Study Design

Enrollment
378 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMCgp100 (tebentafusp, Kimmtrak)
    Biologic:IMCgp100 (Soluble gp 100-specific T cell receptor with anti - CD3 scFV: IMCgp100)
  • Active Comparator: Investigator's Choice
    1 of 3 Investigator's Choice options: Systemic Dacarbazine 1 of 3 Investigator's Choice options: Systemic Ipilimumab 1 of 3 Investigator's Choice options: Systemic Pembrolizumab

Primary Outcome Measure

Efficacy: Overall Survival [ Time Frame: From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months. ]

Locations (23)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
UCLA Medical CenterLos AngelesCalifornia90024-
Byers Eye Institute, Stanford UniversityPalo AltoCalifornia94303-
California Pacific Medical CenterSan FranciscoCalifornia94115-
University of ColoradoAuroraColorado80045-
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
The University of Chicago MedicineChicagoIllinois60637-
University of IowaIowa CityIowa52242-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-
Roswell Park Cancer InstituteBuffaloNew York14263-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Health SystemDurhamNorth Carolina27710-
The Ohio State UniversityColumbusOhio43210-
University of OklahomaOklahoma CityOklahoma73104-
Portland Providence Medical CenterPortlandOregon97213-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Houston Methodist Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUCLA Medical Center· Los Angeles, CAByers Eye Institute, Stanford University· Palo Alto, CACalifornia Pacific Medical Center· San Francisco, CAUniversity of Colorado· Aurora, COUniversity of Miami - Sylvester Comprehensive Cancer Center· Miami, FL

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