Zanzalintinib with Immunotherapy for Clear Cell Kidney Cancer
This study is testing zanzalintinib (XL092) alone or in combination with nivolumab for people with advanced clear cell kidney cancer (renal cell carcinoma). You may be able to join if your cancer has progressed after receiving adjuvant anti-PD-1/PD-L1 therapy. Researchers want to see how many people respond to these treatments. The study plans to enroll 70 participants and is currently recruiting.
- Study design
- This is a Phase 2 study with 70 participants. You will be randomly assigned to receive either zanzalintinib alone or zanzalintinib plus nivolumab.
- What's involved
- Treatment will be given in 28-day cycles and will continue until your cancer progresses, you experience too many side effects, or for other reasons.
- Compensation
- Not stated in the trial record.
- Follow-up
- Overall Response Rate (ORR) will be measured at 6 months.
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NCT06863311
Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
Recruiting
PHASE2Ages 18+InterventionalTreatmentKarie RuncieInvestigator-initiated
~70 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:XL092Nivolumab
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over 6 months
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
Indiana1
Missouri1
New York1
Study leadership
- Karie Runcie, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
Bilirubin: ≤ 1.5 × ULN (for subjects with Gilbert's disease \< 3 x ULN)
Aspartate aminotransferase (AST): ≤ 3 × ULN
Alanine aminotransferase (ALT): ≤ 3 × ULN
Alkaline phosphatase (ALP): ≤ 3 × ULN. For subjects with documented bone metastasis ALP ≤ 5x ULN
International Normalized Ratio (INR): ≤ 1.5 x ULN
Activated Partial Thromboplastin Time (aPTT): ≤ 1.2 × ULN 8. Females of childbearing potential must have a negative urine or serum pregnancy test within 2 weeks prior to registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception. Males able to father a child who are sexually active with female of childbearing potential must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception. 10. Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial. Testing is not required at screening unless mandated by local policy. 11. Patients with known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Testing is not required at screening unless mandated by local policy. 12. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Exclusion
Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).
Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment.
Stroke (including transient ischemic attack \[TIA\]), myocardial infarction, or other clinically significant ischemic event within 12 months before first dose.
Prior history of myocarditis. • Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA/TIA arterial thromboembolic events within 6 months before to first dose. NOTE: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and treated with anticoagulation per standard of care before first dose of study treatment. Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the sponsor-investigator.
Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
Known gastric or esophageal varices
Tumors invading the GI-tract from external viscera.
Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.
Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic.
Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. NOTE: Complete healing of an intra-abdominal abscess must be confirmed before first dose.
Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose.
Cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior V. cava) may be eligible following sponsor-investigator approval.
Any active, known or suspected autoimmune disease. NOTE: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose of study treatment. NOTE: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of systemic corticosteroids for allergic conditions (eg, contrast allergy) is also allowed.
Malabsorption syndrome.
Serious non-healing wound/ulcer/bone fracture. NOTE: Non-healing wounds or ulcers are permitted if due to tumor- associated skin lesions.
Pharmacologically uncompensated, symptomatic hypothyroidism.
Moderate to severe hepatic impairment (Child-Pugh B or C).
Requirement for hemodialysis or peritoneal dialysis.
History of life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4, or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to recur and manageable by standard of care treatment (eg, hypothyroidism).
What this trial measures
- Overall Response Rate (ORR)6 months
ORR is defined as the proportion of patients with partial response and complete response per RECIST version 1.1 criteria at any time prior to 6 months