Treatment combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or Who Refuse Cisplati
- Conditions
- Muscle Invasive Bladder Cancer
- Registration Number
- JPRN-jRCT2031210667
- Lead Sponsor
- Ono Masayuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 66
Histologically or cytologically documented muscle-invasive UC of the bladder.
-Participants with transitional cell and mixed transitional/non-transitional cell histologies;
-Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0.
-Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC.
- Medically fit for cystectomy and able to receive neoadjuvant therapy;
- Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
- ECOG performance status of 0,1,2 at enrollment.
- Availability of tumor sample prior to study entry.
- Must have a life expectancy of at least 12 weeks at randomization.
- Cisplatin-ineligible OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
-Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
-Active infection
-Uncontrolled intercurrent illness
-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 IPs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method