Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or Who Refuse Cisplati
- Conditions
- Bladder CancerMedDRA version: 20.0Level: LLTClassification code: 10005004Term: Bladder cancer NOS Class: 10029104MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-507342-84-00
- Lead Sponsor
- Astrazeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 830
Participants with histologically or cytologically documented muscle-invasive TCC (also known as 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 stage T1N1M0, Participants should also have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC or bladder UC, Medically fit for cystectomy and able to receive neoadjuvant therapy, ECOG performance status of 0, 1, 2 at enrollment, Availability of tumor sample prior to study entry, Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) or Refuse cisplatin based chemotherapy, Must have a life expectancy of at least 12 weeks at randomization
Evidence of lymph node (N2-3) 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method