A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants with Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

Overview

No summary available.

Registry

who.int

Start Date

February 18, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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 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
•\- 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)

•\- 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 could apply.