Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Phase 3 Active not recruiting 1063 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Timeline

Start: 2018-11-16
Primary completion: 2024-04-29
Completion: 2027-11-08

Outcome

Met primary endpoint

registry analysis (superiority test); Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin; p = 0.0005; Odds Ratio (OR) 1.60 NCT03732677 ↗

registry analysis (superiority test); Durvalumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin; p <0.0001; Hazard Ratio (HR) 0.68 NCT03732677 ↗

Publications

Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, Vu TQ, Antonuzzo L, Wiechno P, Atduev V, Kann AG, Kim TH, Suarez C, Chang CH, Roghmann F, Ozguroglu M, Eigl BJ, Oliveira N, Buchler T, Gadot M, Zakharia Y, Armstrong J, Gupta A, Hois S, van der Heijden MS; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024 Nov 14;391(19):1773-1786. doi: 10.1056/NEJMoa2408154. Epub 2024 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	—	—
Background	Cisplatin	Other / unclassified	—	—
Background	Gemcitabine	Small molecule	—	—