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

Phase 1

• Conditions: BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer; MedDRA 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-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-02
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Pathologically demonstrated BCG-unresponsive, CIS-containing highrisk
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

Primary Outcome Measures

Name	Time	Method
Main Objective: -) To estimate complete response (CR) rate, per pathology review<br>committee (PRC), and its duration in carcinoma in situ (CIS)<br>participants.;Secondary Objective: -) To evaluate progression free survival (PFS), per PRC, for all<br>participants.<br>-) To describe the safety and tolerability of nivolumab and nivolumab +<br>BMS-986205, alone or in combination with intravesical BCG.;Primary end point(s): -) Proportion of carcinoma in situ participants with Complete response,<br>per PRC.<br>-) Duration of Complete response (duration of complete response), per<br>PRC, in carcinoma in situ participants with Complete response.;Timepoint(s) of evaluation of this end point: Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- Progression-free Survival (PFS)<br>2- Incidence of Adverse Events (AEs)<br>3- Incidence of Serious Adverse Events (SAEs)<br>4- Incidence of AEs leading to discontinuation<br>5- Incidence of deaths<br>6- Incidence of laboratory abnormalities;Timepoint(s) of evaluation of this end point: 1- Up to 5 years<br>2- Up to 15 months<br>3- Up to 15 months<br>4- Up to 15 months<br>5- Up to 5 years<br>6- Up to 15 months