OncoMatch/Clinical Trials/NCT06863311
Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
Is NCT06863311 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including XL092 and Nivolumab for advanced renal cell carcinoma.
Treatment: XL092 · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — adjuvant
Prior treatment must have included an anti-PD-1. Subjects must have progressed on or after adjuvant anti-PD-1 therapy.
Cannot have received: Zanzalintinib (Zanzalintinib)
Prior treatment with Zanzalintinib.
Cannot have received: small molecule kinase inhibitor
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days prior to study treatment initiation.
Cannot have received: cytotoxic, biologic or other systemic anticancer therapy
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 28 days prior to study treatment initiation unless otherwise specified.
Lab requirements
Blood counts
ANC ≥ 1500/mm3 without G-CSF support within 2 weeks; Platelet Count ≥ 100,000/mm3 without transfusion within 2 weeks; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine < 1.5 ULN OR calculated CrCl >40 mL/min; Urine protein-to-creatinine ratio (UPCR) ≤1mg/mg (≤ 113.2mg/mmol) creatinine
Liver function
Bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's disease < 3 x ULN); AST ≤ 3 × ULN; ALT ≤ 3 × ULN; ALP ≤ 3 × ULN (≤ 5x ULN with bone metastasis)
Demonstrate adequate organ function as defined below. ... Bilirubin: ≤ 1.5 × ULN (for subjects with Gilbert's disease < 3 x ULN); AST: ≤ 3 × ULN; ALT: ≤ 3 × ULN; ALP: ≤ 3 × ULN. For subjects with documented bone metastasis ALP ≤ 5x ULN. ... Serum Creatinine OR Calculated CrCl using Cockgroft Gault equation: Serum creatinine < 1.5 upper limit of normal (ULN) OR calculated Cr Clearance >40mL/min. Urine protein-to-creatinine ratio (UPCR): ≤1mg/mg (≤ 113.2mg/mmol) creatinine. ... Absolute Neutrophil Count (ANC): ≥ 1500/mm3 without granulocytes colony-stimulating factor support within 2 weeks of screening laboratory collection. Platelet Count (PLT): ≥ 100,000/mm3; without transfusion within 2 weeks of screening laboratory sample collection. Hemoglobin (Hgb): ≥ 9 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
- Columbia University Irving Medical Center · New York, New York
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