EUCTR2018-002676-40-GB
Active, not recruiting
Phase 1
A Phase 3, Randomized, Study of Neoadjuvant and AdjuvantNivolumab Plus NKTR-214, Versus Nivolumab Alone VersusStandard of Care in Participants with Muscle-Invasive BladderCancer (MIBC) Who Are Cisplatin Ineligible
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 720
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\- 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)
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.
Outcomes
Primary Outcomes
Not specified
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