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Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
Not Recruiting
Trial ID: NCT03732677
Purpose
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
Official Title
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.
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
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
Intervention(s):
drug: Durvalumab
drug: Cisplatin
drug: Gemcitabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Julie Thu Mai Nguyen
650-723-3046