Tests tebentafusp alone or with pembrolizumab in previously treated advanced melanoma
Compares tebentafusp treatments with standard options in adults with advanced melanoma.
Plain-language title generated from the registry record
Registry title: Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Key facts
- Where
- Montreal, Toronto, and Vancouver, CanadaSee the 3 sites
- Phase
- Phase 3
Where in Canada
- Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)Montreal, CanadaTaking people
- Princess Margaret HospitalToronto, CanadaTaking people
- BC CancerVancouver, CanadaTaking people
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?
Trial details
- Who runs it
- Immunocore Ltd
- Trial code
- NCT05549297EU 2022-502732-39-00
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
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)
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.
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: 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.