Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Immunocore Ltd
Study ID
NCT05549297
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Melanoma

Eligibility Criteria

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

Interventions

  • Tebentafusp — DRUG
    Soluble gp100-specific T cell receptor with anti-CD3 scFV
  • Tebentafusp with Pembrolizumab — DRUG
    Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
  • Investigators Choice — DRUG
    Investigators choice of therapy

Study Details

The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.

Key Dates

Start date
Dec 19, 2022
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: Arm A: Tebentafusp Monotherapy
    Participants receive tebentafusp as single agent.
  • Experimental: Arm B: Tebentafusp + Pembrolizumab
    Participants receive tebentafusp in combination with pembrolizumab.
  • Experimental: Arm C: Investigator's Choice
    Participants receive investigator's choice of therapy.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to ~4 years ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
University of Kansas Cancer Center - WestwoodWestwoodKansas66205-
St Elizabeth Healthcare (St Elizabeth MedicalEdgewoodKentucky41017-
St Elizabeth Healthcare (St Elizabeth Medical Center)EdgewoodKentucky41017-
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Minnesota Medical CenterMinneapolisMinnesota55455-
Mayo Clinic MinnesotaRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Northwell Health Cancer Institute - Zuckerberg Cancer CenterLake SuccessNew York11042-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10068-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Thomas Jefferson University Medical Oncology ClinicPhiladelphiaPennsylvania19107-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Gibbs Cancer Center and Research InstituteSpartanburgSouth Carolina29303-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Houston Methodist Hospital/Houston Methodist Cancer CenterHoustonTexas77030-
University of Utah Huntsman Cancer InstituteSalt Lake CityUtah84112-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZMayo Clinic Florida· Jacksonville, FLOrlando Health Cancer Institute· Orlando, FLWinship Cancer Institute of Emory University· Atlanta, GAUniversity of Kansas Cancer Center - Westwood· Westwood, KSSt Elizabeth Healthcare (St Elizabeth Medical· Edgewood, KY

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