A Study of Nivolumab Plus Bempegaldesleukin (bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded Into the Muscle Wall of the Bladder that has Invaded the Muscle Wall of the Bladder and Who Cannot get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer.

Phase 1

• Conditions: Muscle-Invasive Bladder Cancer; MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002676-40-AT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 720

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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 504

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.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified