A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder (CheckMate 9UT)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Urinary Bladder Neoplasms

Treatments: Drug: BMS-986205; Biological: Nivolumab; Biological: BCG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519256

2017-003581-27 (EudraCT Number)

CA209-9UT

Details and patient eligibility

About

A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without papillary component
• Participants must have CIS to be eligible.
• Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion criteria

• Sign of locally advanced disease or metastatic bladder cancer
• Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
• Prior immuno-oncology therapy

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 4 patient groups

Nivolumab monotherapy

Experimental group

Treatment:

Biological: Nivolumab

Nivolumab + BCG

Experimental group

Treatment:

Biological: BCG

Biological: Nivolumab

Nivolumab + BMS-986205

Experimental group

Treatment:

Biological: Nivolumab

Drug: BMS-986205

Nivolumab + BMS-986205 + BCG

Experimental group

Treatment:

Biological: BCG

Biological: Nivolumab

Drug: BMS-986205