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 CTIS

Registry ID

CTIS2024-512158-12-00

Acronym

CA017-078

Enrollment

386

Registered

2024-06-05

Start date

2018-12-14

Completion date

Unknown

Last updated

2025-10-20

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

Brief summary

Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone, Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo, Event-Free Survival (EFS) of SOC Chemo after RC, Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC

Detailed description

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

Interventions

DRUG1 MG/ML

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCISPLATIN-EBEWE

DRUGKONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI

DRUGGEMSOL

DRUG40 MG/ML

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pathological Complete Response (pCR) rate of neoadjuvent Chemo Alone, Pathological Complete Response (pCR) rate of neoadjuvant Nivo + Chemo, Event-Free Survival (EFS) of SOC Chemo after RC, Event-Free Survival (EFS) of neoadjuvant Nivo + Chemo followed by continued Nivo after RC	—

Secondary

Measure	Time frame
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	—

Countries

Austria, Belgium, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026