Actively Recruiting
Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
Led by Karie Runcie · Updated on 2026-04-03
70
Participants Needed
2
Research Sites
146 weeks
Total Duration
On this page
Sponsors
K
Karie Runcie
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Be 18 years or older at the time of consent
- Have an ECOG Performance Status of 0 or 1 within 28 days prior to registration
- Have advanced or metastatic renal cell carcinoma with a clear cell component
- Have progressed on or after adjuvant anti-PD-1 therapy and completed a 14-day washout period
- Have measurable disease per RECIST 1.1 criteria
- Demonstrate adequate organ function as specified by blood counts, liver and kidney tests within 2 weeks prior to registration
- Females of childbearing potential must have a negative pregnancy test within 2 weeks prior to registration
- Agree to use effective contraception or abstain from sexual intercourse if capable of pregnancy or fathering a child
- Known HIV patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible
- Patients with controlled hepatitis B or cured hepatitis C infections as specified
- Ability to understand and comply with study procedures for the entire study duration
You will not qualify if you...
- Prior treatment with zanzalintinib (XL092)
- Use of any small molecule kinase inhibitor within 14 days prior to study treatment
- Use of cytotoxic, biologic, or other systemic anticancer therapy within 28 days prior to study treatment
- Radiation therapy for bone metastasis within 14 days or other radiation therapy within 28 days prior to treatment
- Known brain metastases or cranial epidural disease unless treated and stable for at least 28 days
- Use of complementary medications to treat the disease within 14 days prior to treatment
- Active infection requiring systemic therapy
- Positive tuberculosis test with active infection requiring treatment
- Pregnant or breastfeeding women
- History of severe allergic reactions to study drugs
- Prior or concurrent malignancy that may interfere with study assessments
- Live attenuated vaccine within 30 days prior to treatment
- History of lung diseases like idiopathic pulmonary fibrosis or active pneumonitis
- Prior organ transplant including stem cell transplant
- Inability to swallow oral medications
- Uncontrolled major cardiovascular, pulmonary, hematologic, or psychiatric conditions
- Therapeutic anticoagulant use with known brain metastases
- Significant gastrointestinal disorders or recent major surgery
- Clinically significant bleeding within 12 weeks prior to treatment
- Other clinically significant disorders including certain autoimmune diseases, immunosuppressive treatments, or severe hepatic impairment
- Corrected QT interval prolongation on ECG
- Inadequately treated adrenal insufficiency
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
K
Karie Runcie, MD
CONTACT
A
Allison Lipps
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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