At a glance
ClinicalIndex Comparison Record- ✓Advanced or metastatic RCC with clear cell component
- ✓Prior anti-PD-1 treatment with progression on or after adjuvant anti-PD-1
- ✓Age ≥18 years at consent
- ✓ECOG Performance Status 0-1 within 28 days prior to registration
- ✕Prior treatment with Zanzalintinib
- ✕Small molecule kinase inhibitor within 14 days prior to study treatment
- ✕Cytotoxic, biologic or other systemic anticancer therapy within 28 days prior
- ✕Other systemic therapy received after anti-PD1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EXACT: Randomized Phase II Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
In Brief
A Phase 2 clinical trial evaluating XL092 and Nivolumab for Advanced Renal Cell Carcinoma and 2 related conditions. Currently recruiting, targeting 70 participants across 4 sites.
Signals
Detailed Summary
The study population for this Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1/PD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of zanzalintinib (XL092) alone and will be taken once daily continuously (Day 1-Day 28). Arm B treatment will consist of XL092 plus nivolumab. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.
Study Details
Timeline
Interventions
100 mg orally
480 mg intravenously.