Brief Title: Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rates at time of cystectomy

Primary Outcome 1 - Timeframe: Up to 6 months

Primary Outcome 2 - Measure: Event-free survival (EFS) per central review defined as time from randomization to event

Primary Outcome 2 - Timeframe: Up to 48 months

CONDITION

• M

ELIGIBILITY

Inclusion:
* Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology

- * Patients must be planning to undergo a radical cystectomy

- * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC

- * ECOG performance status of 0 or 1

- * Must have a life expectancy of at least 12 weeks at randomization
Exclusion:
* Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.

- * Prior pelvic radiotherapy treatment within 2 years of randomization to study

- * 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 investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)

- * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.

- * Uncontrolled intercurrent illness

- * Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

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: N/A

Phone: N/A

Email: N/A

LOCATION