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

Study acronym: SERENE
StatusNot Yet Recruiting
PhasePhase 4
Started

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Record History

  1. Minor Study First Submitted
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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.
Trial Details
NCT Number NCT07876817
Lead Sponsor AstraZeneca
Conditions
(from sponsor)
Muscle-Invasive Bladder Cancer (MIBC)
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov