Zanzalintinib + Nivolumab for Kidney Cancer
(EXPLORE-RCC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments for kidney cancer that is difficult to remove surgically. Participants will receive two medications: zanzalintinib, a potential new drug, and nivolumab, an immunotherapy. The aim is to determine if these medications help shrink the tumor or keep it stable. After 12 weeks, doctors will assess whether surgery is an option or if continued medication is the best course. Eligible participants have kidney cancer that cannot be surgically removed and have not received certain treatments for this cancer before. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires stopping certain medications, such as oral anticoagulants and complementary medicines, before starting the study treatment. If you're on these, you may need to stop them a few days before the trial begins. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of zanzalintinib and nivolumab has been tested in patients with advanced kidney cancer. The treatment proved effective for many, with 63% of patients experiencing tumor shrinkage and 90% seeing either shrinkage or no growth. It is generally considered safe for patients.
While all medications can have side effects, studies suggest that these are manageable for most people. Several studies have tested the combination without major safety concerns, indicating a good level of safety for potential trial participants.12345Why do researchers think this study treatment might be promising for kidney cancer?
Unlike the standard treatments for kidney cancer, which often include drugs like sunitinib or pazopanib, the combination of Zanzalintinib and Nivolumab represents a novel approach. Researchers are excited about this treatment because Zanzalintinib (XL092) is an innovative tyrosine kinase inhibitor that targets multiple pathways involved in tumor growth and spread. When paired with Nivolumab, an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells, the combination could enhance the body's ability to fight the cancer more effectively. This dual-action strategy has the potential to improve outcomes for patients who may not respond well to traditional therapies.
What evidence suggests that this treatment might be an effective treatment for kidney cancer?
Research shows that the combination of zanzalintinib and nivolumab, which participants in this trial will receive, may be promising for treating kidney cancer. Studies found that 63% of patients experienced tumor shrinkage, indicating the treatment's effectiveness for many. Additionally, the treatment prevented cancer growth in 90% of patients. On average, patients lived 18.5 months without their cancer worsening. These findings suggest that zanzalintinib and nivolumab could effectively manage advanced kidney cancer.12367
Who Is on the Research Team?
Qian Qin, MD
Principal Investigator
University of Texas
Are You a Good Fit for This Trial?
This trial is for adults with advanced kidney cancer that can't be removed by surgery or has spread a little. They should be fairly active (able to care for themselves), have recovered from past treatments, and their blood counts need to meet certain levels. People with very small metastases are allowed. Those who've given consent and have confirmed clear cell renal carcinoma diagnosis can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zanzalintinib 100mg orally once daily plus nivolumab standard of care dosing for a total of 12 weeks
Restaging and Evaluation
Participants undergo restaging scan/evaluation for surgical operability
Adaptive Treatment
Participants receive up to 48 weeks total of zanzalintinib plus nivolumab if partial response or stable disease but inoperable, or stop treatment for standard care if disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Zanzalintinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Qian Qin
Lead Sponsor
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
University of Texas
Collaborator