| Titre |
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 |
| Protocole ID |
NIAGARA |
| ClinicalTrials.gov ID |
NCT03732677 |
| Type(s) de cancer |
Vessie/urothélial |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
Gemcitabine, Cisplatine et Durvalumab |
| Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
 HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
| Ville |
Sherbrooke |
| Investigateur(trice) principal(e) |
Dr Michel Pavic
|
| Coordonnateur(trice) |
Anick Champoux
819-346-1110 poste 12811
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- Evidence of lymph node or metastatic 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
|
Groupe d'étude en oncologie du Québec