A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY OF NIVOLUMAB COMBINED WITH IPILIMUMAB VERSUS STANDARD OF CARE CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED UNRESECTABLE OR METASTATIC UROTHELIAL CANCER

A0 个研究点目标入组 0 人开始时间: 2017年7月5日最近更新: 2024年8月20日

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•This will be a randomized, open-label, Phase 3 study comparing combination therapy of
•nivolumab (1 mg/kg 30 minute IV infusion) plus ipilimumab (3 mg/kg 30 minute IV infusion)
•administered every 3 weeks for up to four doses, followed by nivolumab monotherapy (480 mg
•30 minute IV infusion) administered every 4 weeks, versus the standard of care (SOC;
•gemcitabine-cisplatin or gemcitabine-carboplatin) in participants with previously untreated unresectable or metastatic UC. Participants will be randomized 1:1 to treatment Arm A or B then stratified by PD-L1 status < 1%, cisplatin-eligibility, and liver metastasis.
•a) Arm A (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg [N1 + I3], followed by nivolumab
•monotherapy)
•b) Arm B (standard of care [SOC] platinum chemotherapy doublet, 3 week cycles, up to 6

•Histological or cytological evidence of metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra. Measurable disease by CT or MRI per RECIST 1.1 criteria.
•No prior systemic chemotherapy for metastatic or surgically unresectable UC with some exceptions detailed in protocol.
•Cisplatin-ineligible participants will be defined by any one of the following criteria: i. Impaired renal function, ii. Common Terminology Criteria for Adverse Events (CTCAE) version 4, ≥ Grade 2 audiometric hearing loss, iii. CTCAE version 4, ≥ Grade 2 peripheral neuropathy
•Participants eligible for Cisplatin-based chemotherapy must exhibit adequate renal function
•Participants must have an evaluable tumor tissue (fresh biopsy [within 3 months]) prior to randomization. In order to be treated, a participants must be classified as PD-L1
•1% or PDL1 < 1% as determined by a central laboratory during the screening period.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 for ECOG Performance Status scale
•Adequate hematologic and liver function

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