Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Recruiting now Phase 3 NCT05549297
Run by Immunocore Ltd · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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
+ 1 more criteria — see the full checklist in the app.
Where this trial is running
- Mayo Clinic Arizona, Phoenix, Arizona, United States
- Mayo Clinic Florida, Jacksonville, Florida, United States
- Orlando Health Cancer Institute, Orlando, Florida, United States
- Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
- University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States
- St Elizabeth Healthcare (St Elizabeth Medical Center), Edgewood, Kentucky, United States
- St Elizabeth Healthcare (St Elizabeth Medical, Edgewood, Kentucky, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States
- Dana Farber Cancer Institute, Boston, Massachusetts, United States
- University of Minnesota Medical Center, Minneapolis, Minnesota, United States
- Mayo Clinic Minnesota, Rochester, Minnesota, United States
+ 70 more sites.
Who to contact
Immunocore Medical Information · 844-466-8661 · medical.information@immunocore.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05549297.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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