Belzutifan for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests belzutifan, a medication for treating kidney cancer in people with von Hippel Lindau (VHL) disease. Researchers aim to determine if this treatment can manage renal cell carcinoma (RCC), a type of kidney tumor associated with VHL. The trial is open to individuals diagnosed with VHL disease who have at least one measurable kidney tumor that doesn't require immediate surgery. Participants should not have received previous treatment with belzutifan or similar medications. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had any prior systemic anti-cancer therapy.
Is there any evidence suggesting that belzutifan is likely to be safe for humans?
Research shows that belzutifan is generally well-tolerated in people with tumors, including those related to von Hippel-Lindau (VHL) syndrome. Studies have found that most side effects are mild to moderate, such as fatigue or nausea. These are classified as grade 1 or 2, indicating they are less severe.
The FDA has already approved belzutifan for treating certain kidney tumors, which adds confidence in its safety. This approval indicates thorough testing to ensure its safety.
In summary, current data suggests belzutifan is safe, with mostly mild side effects reported.12345Why do researchers think this study treatment might be promising?
Belzutifan is unique because it targets kidney cancer by inhibiting hypoxia-inducible factor-2 alpha (HIF-2α), a new approach compared to traditional treatments like tyrosine kinase inhibitors and immune checkpoint inhibitors. This mechanism of action is important because HIF-2α is a key player in cancer cell survival and growth under low oxygen conditions, which are common in tumors. Researchers are excited about belzutifan because its targeted action could lead to more effective treatments with potentially fewer side effects, offering hope for patients who may not respond well to existing therapies.
What evidence suggests that belzutifan might be an effective treatment for kidney cancer?
Research has shown that belzutifan, which participants in this trial will receive, may effectively treat kidney cancer related to von Hippel-Lindau (VHL) disease. Almost half of the patients experienced tumor shrinkage in this type of kidney cancer. The treatment is primarily associated with mild side effects. Additionally, the duration of benefit from the treatment was not determined, suggesting it may have long-lasting effects for many. This evidence supports belzutifan as a promising option for managing VHL-related kidney cancer.46789
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 individuals with von Hippel Lindau disease who have at least one measurable kidney cancer tumor but don't need immediate surgery. They shouldn't have used belzutifan or similar drugs before, had any cancer treatments like anti-VEGF therapy, require urgent tumor surgery, or have metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 120 mg belzutifan orally once daily. Treatment is continuous with radiological evaluations approximately every 12 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations every 24 weeks or more frequently if clinically indicated.
What Are the Treatments Tested in This Trial?
Interventions
- Belzutifan
Belzutifan is already approved in United States for the following indications:
- Advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI
- Von Hippel-Lindau disease-associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Lead Sponsor
Peloton Therapeutics, Inc.
Lead Sponsor