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

  • 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 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.