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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 127
Updated:4/6/2019
Start Date:November 16, 2018
End Date:December 18, 2025
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with
Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment
in Patients with Muscle-Invasive Bladder Cancer


Inclusion:

- Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0
with transitional cell histology

- Patients must be planning to undergo a radical cystectomy at the time of randomization

- 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 or metastatic disease at time of screening.

- Prior pelvic radiotherapy treatment

- 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
We found this trial at
28
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New Brunswick, New Jersey 08901
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