This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
317
Specified doses on specified days
Specified doses on specified days
Specified doses on specified days
Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC)
Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause
Time frame: Approximately 27 months after the first subject is randomized
Objective response rate (ORR) as assessed by BIRC per RECIST 1.1
Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later
Time frame: Up to 24 months after the first subject is randomized
Duration of Overall Survival (OS)
Defined as the time from randomization to death due to any cause
Time frame: Approximately 46 months after the first subject is randomized
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Exelixis Clinical Site #1
Duarte, California, United States
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Newport Beach, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
Exelixis Clinical Site #42
Cleveland, Ohio, United States
Exelixis Clinical Site #31
Dallas, Texas, United States
...and 153 more locations