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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224662

Enrollment

1200

Registered

2019-05-07

Start date

2018-10-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Interventions

investigational material(s) Generic name etc : Nivolumab, Gemcitabine, Cisplatin INN of investigational material : Nivolumab, -, Gemcitabine, Cisplatin Therapeutic category code : 42- Antineoplastic a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.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. 2.Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion criteria

Exclusion criteria: 1.Clinical evidence of positive lymph node(s) (LN) (10 mm in short axis or more) or metastatic bladder cancer 2.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

Design outcomes

Primary

Measure	Time frame
efficacy Pathological Complete Response (pCR) rate, Event-Free Survival (EFS)	—

Secondary

Measure	Time frame
safety efficacy Overall Survival (OS) , Adverse Events (AE) etc.	—

Countries

Japanetc

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026