Ph 2/3 TEBE-AM trial converted into registrational Ph 3 trial of KIMMTRAK for previously treated advanced cutaneous melanoma
Mark Moyer, SVP, Regulatory Affairs, Immunocore said: “The decision to launch a registrational trial in cutaneous melanoma was based on KIMMTRAK’s overall survival benefit in uveal melanoma, and promising clinical activity as monotherapy and in combination with immune checkpoint therapy in Phase 1 cutaneous melanoma trials. To allow robust testing of two KIMMTRAK regimens and to accelerate the time to primary analysis, we decided, in consultation with the FDA, to amend the protocol into a single Phase 3 registrational study.”
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