A Phase 2 Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with Bladder Cancer
- Conditions
- BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder CancerMedDRA version: 20.0Level: PTClassification code 10005005Term: Bladder cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003581-27-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 480
As of 02-Jun-2021, enrollment into this study was closed. Male participants continuing treatment should follow the updated contraceptive guidance (see protocol).
•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
As of 02-Jun-2021, enrollment into this study was closed. Male participants continuing treatment should follow the updated contraceptive guidance (see protocol).
•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
- Primary Outcome Measures
Name Time Method Main Objective: - To describe the safety and tolerability of nivolumab and nivolumab + BMS-986205, alone or in combination with intravesical BCG.<br>- To characterize the immunogenicity of nivolumab.;Secondary Objective: Not applicable;Primary end point(s): • Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in all treated participants.<br>• Overall safety and tolerability will be measured by the incidence of AEs, Serious Adverse Events (SAEs), AEs leading to discontinuation, immune-mediated AEs, deaths, and laboratory abnormalities and changes from baseline.<br>• Incidence of anti-nivolumab antibodies and their potential relationship with safety ;Timepoint(s) of evaluation of this end point: Up to 5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable<br>;Timepoint(s) of evaluation of this end point: Not applicable