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Brief Title: 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

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: CA209-9UT
  • Secondary ID: 2017-003581-27
  • NTC ID: NCT03519256
  • Sponsor: Bristol-Myers Squibb
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BRIEF SUMMARY

A study to evaluate Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer

  • Overall Status
    Recruiting
  • Start Date
    May 25, 2018
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of carcinoma in situ (CIS) participants with complete response (CR), per Pathology Review Committee (PRC)

Primary Outcome 1 - Timeframe: Up to 5 years

Primary Outcome 2 - Measure: Duration of complete response (DOCR), per PRC, in CIS participants with CR

Primary Outcome 2 - Timeframe: Up to 5 years

CONDITION

  • Bladder Cancer
  • Bladder Tumors
  • Neoplasms
  • Bladder

ELIGIBILITY

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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 could apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: please email

Email: ClinicalTrials@bms.com

LOCATION

Facility Status Contact