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
- Conditions
- Non-muscle invasive bladder cancer10038364
- Registration Number
- NL-OMON55591
- Lead Sponsor
- British Biotech Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
• 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 required within 10 weeks (70 days)
prior to starting treatment and must be confirmed by the Pathology Review
Committee (PRC)
BCG unresponsive disease is defined as being at least one of the following:
- Persistent or recurrent CIS, alone or with recurrent Ta/T1 disease within
12 months of completion of adequate BCG treatment
- Recurrent high-grade Ta/any T1 disease within 6 months of completion of
adequate BCG therapy; per revised protocol 03 participants must also have CIS
to be eligible
- T1 high-grade disease at the first evaluation following an induction BCG
course (at least 5 of 6 induction doses). Per revised protocol 03, participants
must also have CIS to be eligible
Adequate BCG treatment is defined as at least 2 courses of BCG:
- Two induction courses (5 of 6 doses of an initial induction course plus at
least two of six doses of a second induction course) or
- One induction course (at least 5 of 6 induction doses) and
- At least 2 of 3 doses of a maintenance cycle
• All visible tumor completely excised
• No upper tract disease or metastatic disease on cross-sectional imaging
• Medically unfit for, or refused radical cystectomy
• If tumor tissue was obtained > 70 days prior to randomization, participants
must have
a repeat cystoscopy <= 70 days prior to randomization (see Section 9.1.4).
• Urothelial carcinoma in the upper urinary tracts or prostatic urethra
• Metastatic or locally advanced bladder cancer
• Prior malignancy active within last 3 years except for locally curable
cancers that have been apparently cured
• Prior systemic chemotherapy or immunotherapy
• Prior radiation therapy
• Active, known or suspected autoimmune disease
• Personal or family history of cytochrome b5 reductase deficiency
• History of G6PD deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Proportion of CIS participants with CR, per PRC.<br /><br>- Duration of CR (DOCR), per PRC, in CIS participants with CR<br /><br>- EFS, per PRC, for all non-CIS participants</p><br>
- Secondary Outcome Measures
Name Time Method <p>- PFS, per PRC, for all participants<br /><br>- Overall safety and tolerability will be measured by the incidence of AEs,<br /><br>SAEs, AEs leading to discontinuation, immunemediated<br /><br>AEs, deaths, and laboratory abnormalities and changes from baseline.</p><br>