A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer

Completed · Phase 3

Conditions studied: Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer

In brief

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

Key facts

Study ID

NCT04209114

Run by

Bristol-Myers Squibb

People needed

114

Starts

2020-02-05

Expected to finish

2023-06-07

Last updated by the study team

2024-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Urothelial carcinoma (UC) of the bladder, clinical stage T2-T4aN0, M0 or T1-T4aN1, M0, diagnosed at transurethral resection of bladder tumor (TURBT)
• 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%

You may not qualify if…

• Clinical evidence of ≥ N2 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
• Known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias)
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0136 — Tucson, Arizona, United States
• Local Institution - 0029 — La Jolla, California, United States
• Local Institution - 0015 — Orange, California, United States
• Local Institution - 0002 — Iowa City, Iowa, United States
• Local Institution — Rochester, Minnesota, United States
• Local Institution - 0006 — New Brunswick, New Jersey, United States
• Local Institution - 0004 — Buffalo, New York, United States
• Local Institution - 0009 — The Bronx, New York, United States
• Local Institution - 0005 — Allentown, Pennsylvania, United States
• Local Institution - 0007 — Charleston, South Carolina, United States
• Local Institution - 0139 — Houston, Texas, United States
• Local Institution - 0023 — Temple, Texas, United States
• Local Institution - 0122 — Gig Harbor, Washington, United States
• Local Institution - 0102 — Seattle, Washington, United States
• Local Institution - 0096 — Capital Federal, Buenos Aires, Argentina
• Local Institution - 0028 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0124 — La Plata, Buenos Aires, Argentina
• Local Institution - 0027 — Capital Federal, Distrito Federal, Argentina
• Local Institution - 0174 — Rosario, Santa Fe Province, Argentina
• Local Institution - 0097 — Córdoba, Argentina
• Local Institution - 0137 — Gosford, New South Wales, Australia
• Local Institution - 0158 — Ballarat, Victoria, Australia
• Local Institution - 0157 — Fitzroy, Victoria, Australia
• Local Institution - 0011 — Heidelberg, Victoria, Australia
• Local Institution - 0080 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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