Phase 3
N=114
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
Bladder Cancer · Bladder Tumor · Muscle-Invasive Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04209114 ↗Enrolled (actual)
114
Serious AEs
50.0%
Results posted
Jun 2024
Primary outcome: Primary: Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care — 10.8; 2.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nivolumab (Biological); Radical cystectomy (RC) (Procedure); Bempegaldesleukin (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care |
10.8; 2.5 | — |
| PRIMARY Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care |
22.11; 15.18 | — |
| SECONDARY Pathologic Complete Response (pCR) Rate - Nivolumab Compared to Standard of Care |
10.8; 2.5 | — |
| SECONDARY Event Free Survival (EFS) - Nivolumab Compared to Standard of Care |
NA; 15.18 | — |
| SECONDARY Overall Survival (OS) |
NA; NA; 23.23 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) |
34; 36; 19 | — |
| SECONDARY The Number of Participants Experiencing Serious Adverse Events (SAEs) |
15; 18; 14 | — |
| SECONDARY The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation |
8; 8; 0 | — |
| SECONDARY The Number of Participants Experiencing Immune-Mediated Adverse Events (IMAEs) |
10; 10; 0 | — |
| SECONDARY Worst Grade Clinical Laboratory Values |
5; 5; 0; 23; 23; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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%
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04209114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.