What is tivozanib studying for high-risk renal cell carcinoma?

Tivozanib is being studied in combination with pembrolizumab to see if adding it improves treatment outcomes for patients with high-risk kidney cancer. The trial compares this combination to pembrolizumab alone to understand its effects on survival and disease recurrence. The study is sponsored by the Alliance for Clinical Trials in Oncology.

Who may be eligible for this renal cell carcinoma clinical trial?

Adults aged 18 years and older with a confirmed diagnosis of renal cell carcinoma who have had their kidney tumor surgically removed may be eligible. Participants should have good general health and no active infections or uncontrolled high blood pressure. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this renal cell carcinoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan accordingly based on their individual circumstances.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06661720

Phase 3 Study of Adding Tivozanib to Pembrolizumab Immunotherapy After Kidney Cancer Surgery in High-Risk Renal Cell Carcinoma Patients

Led by Alliance for Clinical Trials in Oncology · Updated on 2026-08-05

1040

Participants Needed

421

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of adding the drug tivozanib to the immunotherapy pembrolizumab compared to pembrolizumab alone in patients with high-risk renal cell carcinoma RCC. The study aims to determine whether this combination improves disease-free survival and overall survival. This phase III trial also assesses side effects, quality of life, and collects specimens for future research in patients who have undergone surgery to remove all known kidney cancer sites. In this study, participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days of each 12-week cycle for up to 4 cycles. The other group receives the same pembrolizumab schedule combined with oral tivozanib taken daily on specific days within the 12-week cycle for up to 6 months. Throughout the trial, participants undergo blood samples, MRI or CT scans, and may have tissue biopsies. After treatment, patients are followed regularly for up to 10 years to monitor outcomes. Participants will have scheduled visits during treatment cycles and follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years. The research team measures disease recurrence or death disease-free survival as the main outcome, along with overall survival, side effects, treatment tolerance, and quality of life. Safety monitoring and quality of life assessments are included to evaluate the impact of the treatments over the long term.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed diagnosis of renal cell carcinoma with a clear cell component after complete removal of the primary tumor by radical or partial nephrectomy
Patients with intermediate-high risk or high-risk renal cell carcinoma or no evidence of disease after metastasis removal
Surgery performed between 4 and 16 weeks prior to study registration with no ongoing complications
No evidence of disease at randomization by CT or MRI scans
No prior systemic treatment for renal cell carcinoma
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 or Karnofsky score of 60% or higher
Adequate blood counts and organ function as defined by specific laboratory criteria
Negative pregnancy test and not nursing for women of childbearing potential
HIV-infected patients on effective antiretroviral therapy with undetectable viral load
Hepatitis B and C patients meeting specific viral load and treatment criteria
Cardiac function class IIB or better according to New York Heart Association classification
No history of myocarditis or clinically significant pneumonitis
Controlled blood pressure below specified limits
No serious non-healing wounds, ulcers, or bone fractures within 28 days
No serious or active infection requiring intravenous antibiotics
No moderate or severe liver impairment
No significant bleeding disorders within 1 month
No history of allogeneic organ transplantation
No allergy or hypersensitivity to study drugs or components
No need for systemic corticosteroids or immunosuppressive medications above allowed doses
No active gastrointestinal conditions increasing risk of perforation
Patients with prior or concurrent malignancies not interfering with study assessments
No autoimmune disease requiring systemic treatment in past 2 years except specified exceptions
No use of strong CYP3A4 inducers within 14 days prior to study treatment

You will not qualify if you...

Evidence of gross residual disease after surgery
Uncontrolled hypertension (systolic BP >150 mm Hg or diastolic BP >90 mm Hg) on two measurements
Active peptic ulcer disease, inflammatory bowel disease, or gastrointestinal conditions with risk of perforation
History of myocarditis or clinically significant pneumonitis
Serious non-healing wound, ulcer, or bone fracture within 28 days
Serious or active infection requiring parenteral antibiotics
Moderate or severe hepatic impairment (Child-Pugh B or C)
Significant bleeding disorders within 1 month prior to registration
History of allogeneic organ transplantation
Allergy or hypersensitivity to pembrolizumab, tivozanib, or study components
Systemic corticosteroid treatment above allowed doses within 14 days of treatment start
Use of other immunosuppressive medications within 30 days of randomization
Use of strong CYP3A4 inducers within 14 days prior to study treatment

Research Team

Aishwarya Vijendran

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Phase 3 Study of Adding Tivozanib to Pembrolizumab Immunotherapy After Kidney Cancer Surgery in High-Risk Renal Cell Carcinoma Patients

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria