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

Not Recruiting

Trial ID: NCT03732677


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
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology



   - 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


   - 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


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

New Trial Alerts