Back to search results

Adding Tivozanib to Immunotherapy for High-Risk Kidney Cancer

This study is testing if adding the anti-cancer drug tivozanib to pembrolizumab (an immunotherapy) works better than pembrolizumab alone for people with high-risk kidney cancer (renal cell carcinoma) after surgery. Pembrolizumab helps your body's immune system fight cancer. Tivozanib is a kinase inhibitor, which means it blocks signals that help cancer cells grow and spread. Researchers want to see if combining these two treatments improves how long people live without their cancer returning. You may be able to join if you are 18 or older and have a confirmed diagnosis of clear cell kidney cancer that has been completely removed by surgery. The main goal is to see how long patients remain disease-free.

Study design
This is an interventional study planning to enroll 1040 participants. Participants will be randomly assigned to receive either pembrolizumab with tivozanib or pembrolizumab alone.
What's involved
You would receive pembrolizumab intravenously and potentially tivozanib orally. You would also have blood samples taken, and undergo MRI or CT scans throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
Your disease-free survival will be assessed from the time you are randomly assigned to a treatment group until your disease returns or you pass away, for up to 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06661720

Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Alliance for Clinical Trials in Oncology
~1,040 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:PembrolizumabTivozanibBiospecimen CollectionMRIComputed TomographyBiopsy

At a glance

Recruiting sites
403 of 425 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival (DFS)
Measured over From time of randomization until disease recurrence or death, assessed up to 10 years

Conditions

Clear Cell Renal Cell Carcinoma
Renal Cell Carcinoma (RCC)
Stage II Renal Pelvis Cancer AJCC v8
Stage III Renal Pelvis Cancer AJCC v8

Explore related trials

Clear Cell Renal Cell Carcinoma

NCT06661720

Where you'd take part

This study runs at 425 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Addison Gilbert Hospital

    Gloucester, Massachusettsstudy coordinator listed

    Recruiting

  • AdventHealth Hendersonville

    Hendersonville, North Carolinastudy coordinator listed

    Recruiting

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolinastudy coordinator listed

    Recruiting

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolinastudy coordinator listed

    Recruiting

  • AdventHealth Infusion Center Weaverville

    Weaverville, North Carolinastudy coordinator listed

    Recruiting

  • Advocate Christ Medical Center

    Oak Lawn, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Aishwarya Vijendran
[email protected]
773-702-9171
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

• Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
Intermediate-high risk RCC:
pT2 grade 4 or sarcomatoid features, N0M0
pT3 any grade N0, M0
High-risk RCC
pT4, any grade, N0, M0
pT, any stage., any grade, N+, M0
cM1 no evidence of disease (NED) RCC
Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)
Surgery (radical or partial nephrectomy or metastasectomy or ablation) \> 4 weeks but =\< 16 weeks prior to study registration with no ongoing complications from surgery
No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
No prior systemic treatment for RCC
Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (or Karnofsky \>= 60%)
Absolute neutrophil count (ANC) \>= 1,000/mm\^3
Platelet count \>= 100,000/mm\^3
Hemoglobin \>= 8 g/dL
Total bilirubin =\< 3 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x upper limit of normal (ULN)
Calculated (calc.) creatinine clearance \>= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)
Urine protein =\< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \< 2mg/mg
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\< 14 days prior to registration
HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Hepatitis
Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible
Hepatitis C: 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, they are eligible if they have an undetectable HCV viral load
Cardiac Disease: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better
No history of myocarditis
No history of clinically significant pneumonitis
No uncontrolled hypertension (systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart
No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration
No serious/active infection requiring parenteral antibiotics
No moderate or severe hepatic impairment (child-Pugh B or C)
No significant bleeding disorders within 1 month prior to registration, for example:
Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher
Hemoptysis of pulmonary bleeding grade 3 or higher
Hematuria or other genitourinary bleeding grade 3 or higher
No history of allogeneic organ transplantation
No history of allergy of hypersensitivity to study drugs or components
No condition requiring systemic treatment with either corticosteroid (\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease
No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \> 10 mg/day, or immunosuppressive drugs) with the following exceptions:
Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Brief (\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care
Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded
Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded
Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

What this trial measures

  • Disease-free survival (DFS)From time of randomization until disease recurrence or death, assessed up to 10 years

    The primary analysis will be a comparison of DFS between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group (experimental group versus control group) as the explanatory variable. Interim analyses: There will be several futility analyses for the trial. These analyses will employ the linear 20% method proposed by Freidlin, Korn and Gray. Based on the current design parameters, the first analysis would be performed at 37% information (99 DFS events), and the trial would be stopped for futility if the observed hazard ratio (experimental versus \[vs.\] control) were worse than 1. Additional analyses will be performed at 50% (133 DFS events), 60% (159 DFS events), and 70% information (186 DFS events), the trial would be stopped for futility if the observed HR were worse than 0.983, 0.971 and 0.959, respectively.