Trial intelligence / Profile preview

Phase 3 trial of Adstiladrin alone or with gemcitabine + docetaxel or Keytruda in BCG-unresponsive NMIBC

2024-512177-27-01Phase 3Authorised

Sponsor
Ferring Pharmaceuticals
Start
Sep 2025
Modality
Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Countries
11
01

Overview

Phase 3, randomised, open-label trial in non-muscle-invasive bladder cancer (NMIBC) and urothelial carcinoma in situ (CIS) comparing Adstiladrin monotherapy, Adstiladrin + gemcitabine + docetaxel and Adstiladrin + Keytruda (3 arms). Primary endpoint: Complete response. Planned start Sep 2025; status: authorised.

02

Drugs

nadofaragene firadenovecpembrolizumabgemcitabinedocetaxel
03

Conditions

non-muscle-invasive bladder cancer (NMIBC)urothelial carcinoma in situ (CIS)

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