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Comparing tebentafusp treatment to standard care for advanced melanoma

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)

Phase 3 Interventional Immunocore Ltd · NCT05549297

This study is testing a new treatment called tebentafusp for people with advanced melanoma to see if it works better than the usual care they’ve already received.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years and up
SexAll
SponsorImmunocore Ltd Industry-sponsored
Drugs / interventionspembrolizumab, ipilimumab, chemotherapy
Locations82 sites (Phoenix, Arizona and 81 other locations)
Trial IDNCT05549297 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial evaluates the efficacy and safety of tebentafusp, both as a standalone treatment and in combination with pembrolizumab, against the investigator's choice of standard care in patients with advanced non-ocular melanoma who have previously undergone treatment. The study is multicenter and open-label, focusing on patients who have progressed after prior anti-PD(L)1 and anti-CTLA4 therapies. Participants must provide tumor samples for biomarker analysis and meet specific eligibility criteria related to their disease stage and performance status.

Who should consider this trial

Good fit: Ideal candidates are HLA-A*02:01-positive individuals with unresectable Stage III or IV non-ocular melanoma who have previously been treated with specific therapies.

Not a fit: Patients with ocular or metastatic uveal melanoma, or those with untreated symptomatic CNS metastases, are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced melanoma who have limited treatment choices.

How similar studies have performed: Previous studies have shown promising results with immunotherapy approaches in melanoma, suggesting potential success for this novel treatment regimen.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 81 other locations

+32 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced MelanomaMelanomaIMCgp100TebentafuspCutaneous MelanomaImmunotherapygp100TCR
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.