Pivotal trial of Xdivane

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 25 Mar 2025

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At a glance

Drugs Nivolumab (Primary)
Indications Bladder cancer; Colorectal cancer; Head and neck cancer; Liver cancer; Lung cancer; Malignant melanoma; Renal cancer; Skin cancer; Urogenital cancer
Focus Registrational; Therapeutic Use

25 Mar 2025 New trial record
20 Mar 2025 According to Xbrane media release, Intas is preparing for initiation of the pivotal clinical trial for the program, expected to start in Q2 2025, well in time to be able to finalize the trial in time to support a BLA submission in Q4 2027 at the latest.
20 Mar 2025 According to Xbrane media release, Xbrane expects to have delivered all related documentation to the clinical trial application as well as the clinical trial material to its partner Intas in April 2025, which will trigger a milestone payment.

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