Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in … (NCT03732677) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
United States1,063 participantsStarted 2018-11-16
Plain-language summary
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
Who can participate
Age range18 Years – 130 Years
SexALL
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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
What they're measuring
1
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
Timeframe: Up to 6 months
2
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event