Study on Belzutifan for Advanced Kidney Cancer
Sponsor: Merck Sharp & Dohme LLC
Sponsor score: 40
ClinicalTrials ID:NCT04489771
This clinical trial is testing two different doses of the drug belzutifan to see which is more effective in treating advanced kidney cancer with a clear cell component. The study aims to find out if the higher dose of belzutifan works better than the standard dose in shrinking tumors.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effectiveness and safety of two doses of belzutifan in patients with advanced kidney cancer that has a clear cell component. Researchers want to see if the higher dose of belzutifan is better at reducing tumors compared to the standard dose.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced kidney cancer with a clear cell component.
- Have measurable cancer as determined by specific medical criteria.
- Able to provide a tumor sample for analysis.
- Cancer has worsened after previous treatment with specific immune therapies.
- Have received no more than three prior treatments for advanced kidney cancer.
- Have only received one prior immune therapy for advanced kidney cancer.
- Have recovered from side effects of previous treatments to a mild level.
- Have a performance status score of at least 70%, indicating the ability to care for oneself.
- Male participants must agree to use contraception or abstain from sex during the study and for at least 7 days after the last dose.
- Female participants must not be pregnant or breastfeeding and must agree to use contraception during the study and for at least 30 days after the last dose.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Have low oxygen levels or need oxygen therapy.
- Have another progressing cancer or have been treated for another cancer in the past 3 years, except for certain skin cancers or in situ cancers.
- Have cancer that has spread to the brain or spinal cord.
- Have significant heart disease or recent heart attack.
- Have moderate to severe liver problems.
- Have used certain growth factors within 28 days before starting the study.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Cannot swallow pills or have digestive issues affecting absorption.
- Have allergies to belzutifan or its components.
- Have previously been treated with belzutifan or similar drugs.
- Have used certain cancer treatments or participated in another study recently.
- Have an active infection or tuberculosis.
- Have an immune deficiency or history of HIV, hepatitis B, or hepatitis C.
- Have any condition or treatment that might interfere with the study or not be in the participant's best interest.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Georgetown University Medical Center ( Site 0002) | 20007 | Washington D.C. | District of Columbia |
| Univ of Miami- Sylvester Comprehensive Cancer Center ( Site 0023) | 33136 | Miami | Florida |
| Norton Cancer Institute - St. Matthews ( Site 0025) | 40207 | Louisville | Kentucky |
| Weinberg Cancer Institute at Franklin Square ( Site 0007) | 21237 | Baltimore | Maryland |
| Cancer Partners of Nebraska ( Site 0003) | 68510 | Lincoln | Nebraska |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0012) | 68130 | Omaha | Nebraska |
| New York Oncology Hematology P.C ( Site 0028) | 12206 | Albany | New York |
| Roswell Park Cancer Institute ( Site 0038) | 14263 | Buffalo | New York |
| Fox Chase Cancer Center ( Site 0026) | 19111 | Philadelphia | Pennsylvania |
| Sanford Cancer Center Oncology Clinic ( Site 0031) | 57104 | Sioux Falls | South Dakota |
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