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TEBE-AM Study for Advanced Melanoma

This study is testing tebentafusp, a drug that helps your immune system fight cancer, either alone or with pembrolizumab. Researchers want to see if these treatments are better than what doctors usually choose for advanced melanoma that has already been treated. You might be able to join if you have advanced non-ocular (not affecting the eye) melanoma, are at least 18 years old, and have a specific genetic marker called HLA-A*02:01. The study will look at how long people live (Overall Survival) over about 4 years. This study is currently recruiting about 540 participants.

Study design
This is a Phase 3, multi-center, open-label study comparing tebentafusp regimens to standard care in about 540 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Overall Survival for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05549297

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Immunocore Ltd
~540 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:TebentafuspTebentafusp with PembrolizumabInvestigators Choice

At a glance

Recruiting sites
82 of 82 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to ~4 years

Conditions

Advanced Melanoma

Explore related trials

MelanomaHLA Class I Histocompatibility Antigen, A-0201 Alpha Chain

Where it's being run

82 sites across 38 states
Germany10
Spain6
United Kingdom6
Italy5
Austria4
Poland4
Massachusetts3
Belgium3

Who to contact

Immunocore Medical Information
[email protected]
844-466-8661
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overall Survival (OS)Up to ~4 years

    OS is the time from randomization to death due to any cause.