Taking people in AustriaPhase 3
Tests tebentafusp alone or with pembrolizumab in previously treated advanced melanoma
Compares tebentafusp treatments with standard options in adults with advanced melanoma.
Key facts
- Who runs it
- Immunocore Ltd
- Where
- Graz, Linz, Salzburg, and Vienna, AustriaSee the 4 sitesAlso in 11 other countries, 78 sites
- Trial code
- Registry title
- Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 540 people, planned
- Started
- 19 Dec 2022
- Expected to end
- Jul 2028
- Type of study
- Interventional, 3 groups
- Treatments tested
- Tebentafusp
- Tebentafusp with Pembrolizumab
- Investigators Choice
- Record updated
- 25 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced melanoma that did not start in the eye. The melanoma cannot be removed by surgery. They must be HLA-A*02:01-positive, and their melanoma must have kept growing after earlier treatment.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Stage III (cannot be removed by surgery) or Stage IV melanoma that did not start in the eye, with disease that can be measured or not measured on scans. ECOG performance status 0 or 1.
- Earlier treatment
- Must have kept growing on an anti-PD(L)1 antibody. Must have had an approved anti-CTLA-4 antibody. If the tumor has a BRAF V600 mutation, must have had a BRAF/MEK inhibitor treatment. Must not have had an ImmTAC treatment before.
- Biomarker or test result
- HLA-A*02:01-positive. A tumor sample (stored or new biopsy) and samples for biomarker tests must be provided.
Main reasons for not taking part
- Eye (ocular) melanoma or melanoma that spread from the uvea
- Pregnant or breastfeeding women
- Brain metastases that are untreated or cause symptoms
- Active autoimmune disease needing immune-suppressing treatment
- Past solid organ or other tissue transplant, or chronic hepatitis B or C infection
The registry criteria, word for word
Show all 29 criteriaShow less
Who can take part
- 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
Who cannot take part
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- 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
- 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
- history of a malignant disease other than those being treated in this study
- active autoimmune disease requiring immunosuppressive treatment
- known psychiatric or substance abuse disorders
- 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
- history of allogenic tissue/solid organ transplant
- Out of range Laboratory values
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- 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
- 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
Where in Austria
Also in 11 other countries, 78 sites
- Medical University of GrazGraz, AustriaTaking people
- Johannes Kepler UniversityLinz, AustriaTaking people
- SCRI CCCIT Ges.m.b.H.Salzburg, AustriaTaking people
- Medical University of ViennaVienna, AustriaTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Arm A: Tebentafusp MonotherapyTreatment being tested
Participants receive tebentafusp as single agent.
Treatment: Tebentafusp
- Arm B: Tebentafusp + PembrolizumabTreatment being tested
Participants receive tebentafusp in combination with pembrolizumab.
Treatment: Tebentafusp with Pembrolizumab
- Arm C: Investigator's ChoiceTreatment being tested
Participants receive investigator's choice of therapy.
Treatment: Investigators Choice
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests tebentafusp alone or with pembrolizumab in previously treated advanced melanomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 25 February 2026