Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
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)
-
Clinical Trial Information
Trial Contact: Frankos, Marie; Donaldson, Karin M; Caldwell, Chloe M; Rodriguez Saavedra, Carlis M
Trial Phone: 321.841.7303 ; 321.841.9821 ; (321)841.1107 ; 321.841.6764
-
IRB No: W23.074.04
Protocol Abbrev: IMCgp100-203
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: IMCgp100-203
Treatment: Drug: Tebentafusp Drug: Tebentafusp with Pembrolizumab Drug: Investigators Choice
ClinicalTrials.gov ID: NCT05549297
-
Objective
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.
-
Key Eligibility
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.
