Study Comparing Tivozanib with Nivolumab to Tivozanib Alone in Patients with Advanced Kidney Cancer
Sponsor: AVEO Pharmaceuticals, Inc.
ClinicalTrials ID:NCT04987203
This clinical trial is testing whether combining the drug tivozanib with nivolumab is more effective than using tivozanib alone in treating patients with advanced kidney cancer who have already tried one or two other treatments, including an immune therapy.
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Program Overview
The study aims to find out if using tivozanib together with nivolumab can help patients with advanced kidney cancer live longer without the disease getting worse, compared to using tivozanib alone. It will also look at how long patients live overall, how well the cancer responds to treatment, and the safety of the treatments. About 326 patients will participate, with half receiving the combination treatment and half receiving only tivozanib. Patients will take tivozanib daily for three weeks, followed by a week off. Those receiving nivolumab will get it as an infusion on specific days. Treatment will continue as long as it is effective and well-tolerated, with nivolumab stopping after two years. A follow-up visit will occur about a month after the last treatment dose.
Description
This study is open-label, meaning both the doctors and patients know which treatment is being given. It is randomized, so patients are randomly assigned to receive either tivozanib alone or tivozanib with nivolumab. The study will take place at around 190 locations worldwide. Patients will take tivozanib daily for three weeks, followed by a week off, making a four-week cycle. Those in the combination group will also receive nivolumab infusions on specific days. If the cancer remains stable or improves, patients can continue treatment as long as it is tolerated. Nivolumab will be stopped after two years, but tivozanib can continue if it is still effective. A safety check will be done about a month after the last treatment dose.
Eligibility Criteria
Inclusion Criteria
- Cancer has progressed during or after at least six weeks of treatment with an immune therapy for advanced kidney cancer.
- Side effects from previous treatments have improved to a mild level or returned to normal.
- Confirmed diagnosis of kidney cancer with a clear cell component.
- Cancer can be measured using standard criteria.
- Good overall health, with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must agree to use effective birth control methods as defined by the study protocol.
Exclusion Criteria
- Have received a single tyrosine kinase inhibitor followed by a single immune therapy as previous treatments.
- Have had more than two previous treatments for advanced or metastatic cancer.
- Have had severe side effects from previous immune therapies.
- Have an active autoimmune disease or had to stop previous immune therapy due to immune-related side effects.
- Have uncontrolled high blood pressure.
- Have had more than one previous immune therapy for metastatic cancer.
- Are on immune-suppressing medication for an organ transplant or have a history of immune system disorders, such as HIV, unless well-controlled with medication.
- Have a history of significant lung disease or current lung inflammation not caused by infection.
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