Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
About the study
To evaluate the efficacy and safety of tebentafusp-based regimens 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 take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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 with clinically significant cardiac disease or impaired cardiac function
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication 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 ipilimumab
- 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)
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Melanoma
Age (in years)
18+
Phase
Phase 2/Phase 3
Participants Needed
460
Est. Completion Date
Sep 30, 2027
Treatment Type
Interventional
Sponsor
Immunocore Ltd
ClinicalTrials.gov NCT Identifier
NCT05549297
Study Number
IMCgp100-203
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