Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplati
- Conditions
- Documented muscle-invasive urothelial carcinoma (UC) of the bladder incisplatin ineligible patientsMedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005452-38-GR
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 830
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;
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.
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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method