Tivozanib + Nivolumab for Kidney Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants must have recovered from the side effects of previous treatments, which might imply some changes to your current medication regimen.
What data supports the effectiveness of the drug combination Tivozanib and Nivolumab for kidney cancer?
Research shows that Nivolumab, an immune system-boosting drug, improves survival in patients with advanced kidney cancer, and Tivozanib has been found to significantly delay cancer progression compared to another drug, Sorafenib. These findings suggest that combining these drugs could be effective for treating kidney cancer.12345
Is the combination of Tivozanib and Nivolumab safe for humans?
There is safety data available for Nivolumab, which has been used in combination with other drugs for kidney cancer. Studies have shown that Nivolumab, when combined with other treatments, has a manageable safety profile, meaning that while there can be side effects, they are generally considered controllable.678910
What makes the drug combination of Tivozanib and Nivolumab unique for kidney cancer?
The combination of Tivozanib and Nivolumab is unique because Tivozanib is a highly selective VEGFR inhibitor that targets blood vessel growth in tumors, while Nivolumab is an immune checkpoint inhibitor that helps the immune system attack cancer cells. This combination aims to improve treatment effectiveness by using two different mechanisms to fight kidney cancer.24111213
What is the purpose of this trial?
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).
Eligibility Criteria
This trial is for adults with advanced kidney cancer who've had 1 or 2 previous treatments, including an immune therapy. They must have clear cell renal carcinoma, measurable disease, be in good physical condition (able to perform daily activities), and use contraception. Excluded are those with active autoimmune diseases, uncontrolled high blood pressure, more than one prior immune therapy in the metastatic setting, severe past reactions to immune therapies, certain treatment sequences or over two lines of prior therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tivozanib with or without nivolumab for 3 weeks followed by 1 week off, repeated in cycles until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
Treatment Details
Interventions
- Nivolumab
- Tivozanib
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AVEO Pharmaceuticals, Inc.
Lead Sponsor
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania