Clinical Trial: Bladder Cancer, Cancer

BMS-CA045-009

Full Name

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

Description

The purpose of the study is to see if treatment with nivolumab plus NKTR-214 or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.

Eligibility

Inclusion Criteria
  • 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%
Exclusion Criteria
  • 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 or urothelial carcinoma not confined to the bladder.
Doctor(s) Running This Study