Brief Summary
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 advancedat a late stage, far along or metastatic nccRCC who have not received prior systemic anticancer therapy.
Intervention / Treatment
- Drug: XL092
- Drug: Nivolumab
- Drug: Sunitinib Malate
Inclusion Criteria:
- Histologically confirmed nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed.
- Measurable disease according to RECIST v1.1 as determined by the Investigator.
- Available archival tumor biopsyremoval of a section of tissue to analyse for cancer cells material.
- Recovery to baseline or ≤ Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1 per CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
- Age 18 years or older on the day of consent.
- Karnofsky Performance Status (KPS) ≥ 70%.
- Adequate organ and marrow function within 14 days prior to randomization.
- Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception.
- Female subjects of childbearing potential must not be pregnant at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.