A Phase 2 Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with Bladder Cancer

Phase 1

• Conditions: BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer; MedDRA version: 20.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003581-27-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-31
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 480

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 336

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified