Accepting New Patients
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.
- 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%
- 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.