Trial Search Results

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

The purpose of the study is to find more effective treatment for Muscle Invasive Bladder Cancer. Study determines the efficacy and safety of Durvalumab in combination with Gemcitabine (G) and Cisplatin (C).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Stanford Investigator(s):

Intervention(s):

  • Drug: Durvalumab
  • Drug: Cisplatin
  • Drug: Gemcitabine

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Julie Thu Mai Nguyen
650-723-3046
Not Recruiting