IAGARA
- Conditions
- Muscle Invasive Bladder Cancer
- Registration Number
- JPRN-jRCT2080224149
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 121
Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0/1M0 with transitional and mixed transitional cell histology
- Patients must be planning to undergo a radical cystectomy
- Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
- ECOG performance status of 0 or 1
- Must have a life expectancy of at least 12 weeks at randomization
- Evidence of lymph node (N2-N3) or metastatic disease at time of screening
- Prior pelvic radiotherapy treatment within 2 years of randomization to study
- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies
- Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
- Uncontrolled intercurrent illness
- Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>-
- Secondary Outcome Measures
Name Time Method efficacy<br>-