Trial Profile

A phase 3 registrational study for Cylembio for the treatment of first-line patients with advanced melanoma

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 11 Dec 2025

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At a glance

Drugs Adjuvanted imsapepimut and etimupepimut (Primary)
Indications Malignant melanoma
Focus Registrational; Therapeutic Use
Sponsors IO Biotech

Most Recent Events

14 Nov 2025 According to an IO Biotech media release, The company has a meeting with the United States (US) Food and Drug Administration (FDA) scheduled in December to align on the design of a potential new Phase 3 registrational trial for the treatment of advanced melanoma.
06 Nov 2025 New trial record

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