| Titre |
A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible |
| Protocole ID |
CA045-009 |
| ClinicalTrials.gov ID |
NCT04209114 |
| Type(s) de cancer |
Vessie/urothélial |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Nivolumab plus NKTR-214 versus nivolumab seul |
| 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 |
- MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder tumor (TURBT) and confirmed by radiographic imaging.
- Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to undergo RC. For arms A and B, participants must agree to undergo RC after completion of neoadjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
-
Cisplatin-ineligible participants will be defined by any one of the following criteria:
i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii) GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii) Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing loss (assessed per local SOC).
iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy.
- Documented Left Ventricular Ejection Fraction (LVEF) more than 45%
- Women and men must agree to follow specific methods of contraception, if applicable
|
| Critètes d'exclusion |
- Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer.
- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if completed at least 6 weeks prior to initiating study treatment.
- Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal pelvis) or history of previous MIBC
- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic attack) arterial thromboembolic event
Other protocol-defined inclusion/exclusion criteria apply
|
Groupe d'étude en oncologie du Québec