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) logo

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)

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

Trial documents
1

Trial contacts and locations

88

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Data sourced from clinicaltrials.gov

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