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Clinical trial · no report yet · Phase 3

NCT03661320

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
X threads3
Bluesky threads1

The trial

ClinicalTrials.gov
Official title
A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer
Phase
Phase 3
Status
Completed
Conditions
Urinary Bladder Neoplasms; Muscle-Invasive Bladder Cancer
Interventions
Nivolumab; Gemcitabine; Cisplatin
Arms
  • Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy · Active comparator
  • Arm B: Nivolumab + GC Chemotherapy · Experimental
Enrollment
855
Primary outcomes
  • Pathological Complete Response (pCR) rate, in all randomized participants
  • Event-Free Survival (EFS), in all randomized participants
Sponsor
Bristol-Myers Squibb with Ono Pharmaceutical Co., Ltd.
Start
Nov 6, 2018
Primary completion
Feb 16, 2026
Results posted
No
Registry record
NCT03661320 · updated Sep 10, 2026

Publications

linked from the registry
  • Grivas P, Koshkin VS, Chu X, Cole S, Jain RK, Dreicer R, Cetnar JP, Sundi D, Gartrell BA, Galsky MD, Woo B, Li-Ning-Tapia E, Hahn NM, Carducci MA. PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy. Eur Urol Oncol. 2024 Aug;7(4):914-922. doi: 10.1016/j.euo.2023.11.022. Epub 2023 Dec 27. PubMed 38155060
  • Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11. PubMed 31823654