| Titre |
A Phase 3 Randomized Study of Cystectomy Plus Perioperative Pembrolizumab Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer |
| Protocole ID |
MK-3475-905 (KEYNOTE-905) |
| ClinicalTrials.gov ID |
NCT03924895 |
| Type(s) de cancer |
Vessie/urothélial |
| Phase |
Phase III |
| Type étude |
Traitement |
| Médicament |
Pembrolizumab |
| Institution |
CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
 HOPITAL DE CHICOUTIMI
305, rue Saint-Vallier G7H 5H6 , Chicoutimi, QC
|
| Ville |
Chicoutimi |
| Investigateur(trice) principal(e) |
Dr Jean-Benoit Paradis
|
| Coordonnateur(trice) |
Pascale Duchesne
418-541-1000 poste 2840
Sabrina Côté
418-541-1000 poste 3065
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology. Participants with mixed histology are eligible provided the urothelial component is ≥50%. Urothelial carcinomas not originating from the bladder are not eligible. Participants whose tumors contain any neuroendocrine component are not eligible.
- Clinically non-metastatic bladder cancer determined by imaging
- Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND ), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)
- Ineligible for treatment with cisplatin, as defined by meeting at least one of the following criteria:
- Impaired renal function with measured or calculated CrCl 30 to 59 mL/min
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- Common Terminology Criteria for Adverse Events (CTCAE) v.4 Grade ≥2 audiometric hearing loss
- CTCAE v.4 Grade ≥2 peripheral neuropathy
- New York Heart Association (NYHA) Class III heart failure
- Transurethral resection (TUR) of a bladder tumor that is submitted and adequate for evaluation of histology, muscle invasion and PD-L1 status
- ECOG performance status of 0, 1, or 2
- Adequate organ function
|
| Critètes d'exclusion |
- Known additional non-urothelial malignancy that is progressing or has required active treatment ≤3 years of study randomization, with certain exceptions
- Received any prior systemic anti-neoplastic treatment for muscle-invasive bladder cancer (MIBC)
- Received prior therapy with a anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Received prior systemic anti-cancer therapy including investigational agents within 3 years prior to randomization
- Received any prior radiotherapy to the bladder
- Received a live vaccine within 30 days prior to the first dose of study drug
- Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention
- Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
- Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients
- Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed.
- History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- Active infection requiring systemic therapy
|
Groupe d'étude en oncologie du Québec