Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or Who Refuse Cisplati

Phase 1

• Conditions: Documented muscle-invasive urothelial carcinoma (UC) of the bladder in cisplatin ineligible patients or Who Refuse Cisplatin; MedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005452-38-AT
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-29
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

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.
-Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy.
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

Exclusion Criteria

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