A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer Cle-Invasive

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a Phase 4, Single Arm Study To Assess The Safety and tolerability of Perioperative Durvalumab in Combination with Neoadjuvant Gemcitabine Plus Cisplatin Treatment Followed by radical cystectomy and Durvalumab alone as Treatment in Indian Patients with Muscle-Invasive Bladder Cancer. It is to be conducted in compliance with a condition of approval specified by Health Authority of India following the addition of this indication to the approved prescribing information. A phase IV clinical trial to Asses the safety profile of this regimen in patients from India and subsequently, any regulatory action resulting from the review should be complied.
Epistemonikos ID: 0eaa16b46ae2cb644954d1b108f74729504f5fc5
First added on: Oct 16, 2026