Belzutifan + Zanzalintinib for Kidney Cancer
(LITESPARK-033 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of two drugs, belzutifan and zanzalintinib, can treat advanced kidney cancer more effectively than the current treatment, cabozantinib. Researchers seek to find out if this new treatment can extend patients' lives and prevent cancer progression. The trial targets individuals with advanced kidney cancer that has recurred after specific therapies. As a Phase 3 trial, it represents the final step before FDA approval, providing patients an opportunity to access potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Recent studies have shown that belzutifan is generally well-tolerated by patients. Common side effects include fatigue and dizziness, typically mild. Some patients experienced more serious side effects, such as low oxygen levels in the blood, but these were less common.
Early reports on zanzalintinib indicate a safety profile similar to other treatments in its category. Common side effects include nausea and diarrhea, with some patients experiencing increased blood pressure.
As this trial is in a later phase, researchers have already gathered substantial safety data. This data suggests that the combination of belzutifan and zanzalintinib is reasonably safe for further study. However, new side effects may still emerge, so all participants are closely monitored.
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for kidney cancer because they offer new ways to tackle the disease. Belzutifan, combined with Zanzalintinib, targets a novel pathway in cancer cells, potentially improving outcomes by starving tumors of oxygen. Unlike traditional treatments like sunitinib or pazopanib, which focus on blocking blood vessel growth, this combination aims to directly disrupt tumor metabolism. Meanwhile, Cabozantinib, the comparator, is already known for its effectiveness in targeting specific cancer growth pathways, but the new combination could provide an even more effective approach. These advancements could lead to more effective and targeted treatment options for patients with kidney cancer.
What evidence suggests that this trial's treatments could be effective for kidney cancer?
This trial will compare the combination of belzutifan and zanzalintinib with cabozantinib for treating advanced kidney cancer. Research has shown that using belzutifan and zanzalintinib together may help treat this condition. One study found that patients taking this combination experienced longer periods of stable cancer and better treatment responses compared to those taking cabozantinib. Additionally, belzutifan alone improved conditions in 22% of kidney cancer patients. When zanzalintinib was combined with another drug, it showed a 63% response rate in advanced kidney cancer cases. These findings suggest that belzutifan and zanzalintinib together could effectively treat recurrent advanced kidney cancer.12345
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with advanced kidney cancer (renal cell carcinoma) that has come back after or during treatment with certain immunotherapies. Participants must not have had other treatments for their advanced cancer and need to have measurable disease.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive belzutifan and zanzalintinib or cabozantinib until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belzutifan
- Cabozantinib
- Zanzalintinib
Trial Overview
The study compares two treatments: one group gets belzutifan plus zanzalintinib, while the other receives cabozantinib alone. The goal is to see which approach helps people live longer and keeps the cancer from getting worse.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive belzutifan orally once daily (QD) PLUS zanzalintinib orally QD until one of the reasons for discontinuation of study intervention are met.
Participants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
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
Citations
ASCO 2026: LITESPARK-033: Phase 3 Study of Belzutifan ...
Notably, the phase III LITESPARK-011 trial previously demonstrated superior progression-free survival and objective response rate for belzutifan ...
A Clinical Study of Belzutifan and Zanzalintinib in People ...
People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib. Official Title. A Phase ...
Belzutifan Efficacy and Tolerability in Patients with ...
The median OS was 14.72 mo (95% CI 7.34-22.10). Of 22 patients, four (18.2%) patients required dose reductions and three (13.6%) patients ...
Belzutifan and Zanzalintinib Combination for Advanced ...
This phase 3 study aims to evaluate the effectiveness of Belzutifan and Zanzalintinib combination in improving overall survival and delaying disease ...
Belzutifan + Zanzalintinib for Kidney Cancer
Studies have shown promising results for belzutifan in treating kidney cancer. Patients who received belzutifan responded better, with 22% showing improvement ...
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