Femme et Homme | Entre 18 ans et 130 ans
- | Pays :
- France
- | Organes :
- Vessie
- | Spécialités :
- Chimiothérapie
- Immunothérapie - Vaccinothérapie
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