Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-Invasive Bladder Cancer | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Arm B: Nivolumab + GC Chemotherapy
- interventionNames
- Biological: Nivolumab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Pathological Complete Response (pCR) rate, in all randomized participants
- timeFrame
- Approximately 43 months
- description
- Arm B vs. Arm A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Exclusion Criteria: * Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer * Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
References
Publications (2)
- DERIVEDGrivas 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. PMID 38155060
- DERIVEDSonpavde 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. PMID 31823654