Extrait

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

Extrait Scientifique

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;

Critère d'inclusion

• Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 with transitional cell histology
• Patients must be planning to undergo a radical cystectomy at the time of randomization
• 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

Critère de non inclusion

• Evidence of lymph node or metastatic disease at time of screening.
• Prior pelvic radiotherapy treatment
• 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

Liens

• e-cancer.fr
• Fiche de l'U.S. National Library of Medicine (NLM), sur ClinicalTrials.gov