A study of Chemo only versus Chemo plus Nivo with or without BMS-986205, Followed by Post- Surgery Therapy with Nivo or Nivo and BMS-986205 in Patients with MIBC

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

EU CTR

Registry ID

EUCTR2017-004692-31-NO

Enrollment

1600

Registered

2018-12-05

Start date

2019-02-07

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Bladder Cancer Muscle-Invasive Bladder Cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10022877 Term: Invasive bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Opdivo (100 mg/10 ml) Product Name: NIVOLUMAB - 10ml vial-CLINICAL Product Code: BMS-936558 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: NIVOLUMAB CAS Nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Participants with MIBC, clinical stage T2-T4a, N0 (=65 years) yes F.1.3.1 Number of subjects for this age range 1120

Exclusion criteria

Exclusion criteria: -Clinical evidence of positive LN (= 10 mm in short axis) or metastatic bladder cancer -Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is also not permitted -Ineligible to receive cisplatin due to Grade 2 or higher peripheral neuropathy or audiometric hearing loss, or calculated (Cockcroft-Gault formula) GFR or measured (24-hour urine) creatinine clearance (CrCl) < 50 mL/min

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the pCR rate of neoadjuvant nivolumab + GC to neoadjuvant GC alone in all randomized participants (Arm B vs. Arm A). To compare EFS of neoadjuvant nivolumab + GC followed by continued nivolumab after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs. Arm A).;Secondary Objective: To compare overall survival (OS) of neoadjuvant nivolumab + GC followed by continued nivolumab therapy after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs Arm A). To describe the safety and tolerability of nivolumab and nivolumab in combination with GC chemotherapy. Secondary (Descriptive):To compare efficacy endpoints descriptively in all concurrently randomized patients (Arm C vs Arm B and Arm A).;Primary end point(s): 1/ Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone 2/ Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo 3/ Event-Free Survival (EFS) of SOC Chemo after RC 4/ Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC;Timepoint(s) of evaluation of this end point: 1/ Approx. 39 months 2/ Approx. 39 months 3/ Approx. 57 months 4/ Approx. 57 months	—

Measure

Time frame

Main Objective: To compare the pCR rate of neoadjuvant nivolumab + GC to neoadjuvant GC alone in all randomized participants (Arm B vs. Arm A). To compare EFS of neoadjuvant nivolumab + GC followed by continued nivolumab after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs. Arm A).;Secondary Objective: To compare overall survival (OS) of neoadjuvant nivolumab + GC followed by continued nivolumab therapy after RC versus neoadjuvant SOC GC followed by RC in all randomized participants (Arm B vs Arm A). To describe the safety and tolerability of nivolumab and nivolumab in combination with GC chemotherapy. Secondary (Descriptive):To compare efficacy endpoints descriptively in all concurrently randomized patients (Arm C vs Arm B and Arm A).;Primary end point(s): 1/ Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone 2/ Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo 3/ Event-Free Survival (EFS) of SOC Chemo after RC 4/ Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC;Timepoint(s) of evaluation of this end point: 1/ Approx. 39 months 2/ Approx. 39 months 3/ Approx. 57 months 4/ Approx. 57 months

—

Secondary

Measure	Time frame
Secondary end point(s): Overall Survival (OS) Incidence of Adverse Events (AE) Incidence of Serious Adverse Events (SAE) Incidence of Laboratory abnormalities pCR rate, EFS, and OS as defined;Timepoint(s) of evaluation of this end point: Approx. 60 months	—

Countries

Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026