Last updated on February 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Muscle Invasive Bladder Cancer
  • Age: Between 18 - 130 Years
  • Gender: Male or Female

  • Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 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 or metastatic 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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