Titre |
A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients |
Protocole ID |
POTOMAC |
ClinicalTrials.gov ID |
NCT03528694 |
Type(s) de cancer |
Vessie/urothélial |
Phase |
Phase III |
Type étude |
Traitement |
Médicament |
Durvalumab et Bacillus Calmette-Guerin |
Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Fred Saad
|
Coordonnateur(trice) |
Amal Nadiri
514-890-8000 poste 26074
|
Statut |
Fermé |
Critètes d'éligibilité |
- Aged at least 18 years
- BCG-naïve patients.
- Documented evidence of high-risk transitional cell bladder carcinoma stages T1 tumor, High grade/G3 tumor, CIS, or multiple and recurrent and large (with diameter of largest evaluable node ≥3 cm) tumors (all conditions must be met in this point)
- Complete resection of all Ta/T1 papillary disease.
- No prior radiotherapy to the bladder.
- No prior exposure to immune-mediated therapy of cancer.
|
Critètes d'exclusion |
- Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV).
- Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
- Previous investigational product (IP) assignment in the present study
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
- Active or prior documented autoimmune or inflammatory disorders (eg, colitis, Crohn's disease, Graves' disease, rheumatoid arthritis etc.)
- History of another primary malignancy
- Active infection including TB, HBV, HCV and HIVActive infection.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
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