RecruitingPhase 2NCT06863311

Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

EXACT: Randomized Phase II Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC

Sponsor

Karie Runcie

Enrollment

70 participants

Start Date

Mar 13, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Renal Cell Carcinoma Advanced Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug combination — zanzalintinib (XL092, a targeted drug) plus immunotherapy — in people with clear cell kidney cancer (RCC) that returned or spread after receiving standard post-surgery immunotherapy. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic clear cell kidney cancer - You previously received anti-PD-1 immunotherapy as adjuvant (post-surgery) treatment and your cancer progressed afterward - You are in reasonably good health (ECOG 0–1) **You may NOT be eligible if...** - You have not had prior anti-PD-1 adjuvant therapy for kidney cancer - You are in poor overall health (ECOG 2 or higher) - You have not recovered from side effects of your prior treatment - You have active brain metastases that are not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXL092

100 mg orally

DRUGNivolumab

480 mg intravenously.

Locations(2)

Washington University School of Medicine

St Louis, Missouri, United States

Columbia University Irving Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06863311

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