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

NCT03732677

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Muscle Invasive Bladder Cancer

Interventions: Durvalumab, Cisplatin, Gemcitabine

Countries: United States, Australia, Belgium, Brazil, Canada, Chile, Czechia, France

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (188)
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • New Haven, Connecticut, United States
  • Chicago, Illinois, United States
  • Geneva, Illinois, United States
  • Iowa City, Iowa, United States
  • Westwood, Kansas, United States
  • Louisville, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Towson, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Bethlehem, Pennsylvania, United States
  • Burlington, Vermont, United States
  • Milwaukee, Wisconsin, United States
  • Brisbane, Australia
  • Elizabeth Vale, Australia
  • Macquarie University, Australia
  • Melbourne, Australia
  • Murdoch, Australia
  • South Brisbane, Australia
  • Bruges, Belgium
  • Charleroi, Belgium
  • Kortrijk, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Roeselare, Belgium
  • + 158 more on CT.gov