A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants with Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

Bristol-Myers Squibb International Corporation0 个研究点目标入组 720 人开始时间: 2019年2月18日最近更新: 2021年11月8日

适应症

试验速览

暂无简介。

•- 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)
•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

•- 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.

发起方