Recruiting
Phase 3

Tebentafusp

Sponsor:

Immunocore Ltd

Code:

NCT05549297

Conditions

Advanced Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tebentafusp

Tebentafusp with Pembrolizumab

Investigators Choice

Study Details

Brief summary:

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.

Conditions

Advanced Melanoma

Study ID

NCT05549297

Start date

Dec 19, 2022

Status verified date

Feb, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • HLA-A\*02:01-positive
  • unresectable Stage III or Stage IV non-ocular melanoma
  • archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
  • measurable or non-measurable disease per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • If applicable, must agree to use highly effective contraception
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
  • Must agree to provide protocol specified samples for biomarker analyses.

Exclusion Criteria:

  • Pregnant or lactating women
  • diagnosis of ocular or metastatic uveal melanoma
  • history of a malignant disease other than those being treated in this study
  • ineligible to be retreated with pembrolizumab due to a treatment-related AE
  • known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
  • previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
  • active autoimmune disease requiring immunosuppressive treatment
  • known psychiatric or substance abuse disorders
  • received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications.
  • received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
  • received cellular therapies within 90 days of study intervention
  • ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study
  • received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
  • have not progressed on treatment with an anti-PD(L)1 mAb
  • have not received prior treatment with an approved anti-CTLA-4 mAb
  • have a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
  • currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
  • known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
  • Out of range Laboratory values
  • history of allogenic tissue/solid organ transplant

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Tebentafusp

Soluble gp100-specific T cell receptor with anti-CD3 scFV

Tebentafusp with Pembrolizumab

Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab

Investigators Choice

Investigators choice of therapy

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Immunocore Medical Information

844-466-8661medical.information@immunocore.com

Immunocore Medical Information EU

+00 800-744-51111medinfo.eu@immunocore.com

Locations

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Winship Cancer Institute of Emory University

Recruiting

Atlanta, Georgia, United States, 30322

University of Kansas Cancer Center - Westwood

Recruiting

Westwood, Kansas, United States, 66205

St Elizabeth Healthcare (St Elizabeth Medical Center)

Recruiting

Edgewood, Kentucky, United States, 41017

St Elizabeth Healthcare (St Elizabeth Medical

Recruiting

Edgewood, Kentucky, United States, 41017

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center (BIDMC)

Recruiting

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Northwell Health Cancer Institute - Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10068

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Thomas Jefferson University Medical Oncology Clinic

Recruiting

Philadelphia, Pennsylvania, United States, 19107

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Gibbs Cancer Center and Research Institute

Recruiting

Spartanburg, South Carolina, United States, 29303

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Houston Methodist Hospital/Houston Methodist Cancer Center

Recruiting

Houston, Texas, United States, 77030

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Immunocore Ltd

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Melanoma
  • IMCgp100
  • Tebentafusp
  • Cutaneous Melanoma
  • Immunotherapy
  • gp100
  • TCR
  • Pembrolizumab
  • Bispecific T cell receptor fusion protein
  • ImmTAC (Immune-mobilizing monoclonal T-cell receptor Against Cancer)
  • Immune mobilizing monoclonal T cell receptor against cancer
  • KIMMTRAK
  • Acral Melanoma
  • Mucosal Melanoma
  • Blue Nevus
  • anti-PDL1
  • checkpoint therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Immunocore Ltd on 2026-02-25.