Brief Title: Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Muscle Invasive Bladder Cancer

ELIGIBILITY

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;

- * 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, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy (must be documented in the medical records)
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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION