Study Comparing Belzutifan and Lenvatinib with Cabozantinib for Treating Advanced Kidney Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT04586231
This clinical trial is testing whether a combination of the drugs Belzutifan and Lenvatinib is more effective than Cabozantinib in treating advanced kidney cancer with a clear cell component. The study focuses on patients whose cancer has progressed after previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effectiveness and safety of two treatment options for advanced kidney cancer. One group will receive a combination of Belzutifan and Lenvatinib, while the other group will receive Cabozantinib. Researchers aim to find out which treatment helps patients live longer without their cancer getting worse and which one improves overall survival.
Eligibility Criteria
Inclusion Criteria
- Have advanced kidney cancer that cannot be removed by surgery.
- Cancer has worsened after treatment with specific immune therapies.
- Have measurable cancer according to specific medical criteria.
- Be in good general health with a performance status score of at least 70%.
- Have received no more than two previous treatments for advanced cancer.
- Have only received one prior immune therapy for kidney cancer.
- Men must agree to use contraception during the study and for a short period after.
- Women must not be pregnant or breastfeeding and must agree to use contraception during the study and for a specified time after.
- Have controlled blood pressure and adequate organ function.
Exclusion Criteria
- Have low oxygen levels or need oxygen support.
- Have another active cancer that required treatment 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 prolonged heart rhythm issues.
- Have fluid around the lungs causing symptoms.
- Have severe liver problems or significant bleeding history.
- Have had an organ transplant.
- Have mental health or substance abuse issues affecting study participation.
- Cannot swallow pills or have digestive issues affecting medication absorption.
- Have allergies to the study drugs.
- Have used certain growth factors recently.
- Have previously been treated with Belzutifan, Lenvatinib, or Cabozantinib.
- Are participating in another clinical trial.
- Have an active infection requiring treatment.
- Have a history of HIV or active hepatitis B or C infections.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ironwood Cancer & Research Centers ( Site 0077) | 85224 | Chandler | Arizona |
| Cedars Sinai Medical Center ( Site 0027) | 90048 | Los Angeles | California |
| UCLA Hematology/Oncology - Santa Monica ( Site 0048) | 90404 | Los Angeles | California |
| St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095) | 92868 | Orange | California |
| UC Irvine Health ( Site 0029) | 92868 | Orange | California |
| Providence Saint John's Health Center ( Site 0083) | 90404 | Santa Monica | California |
| Georgetown University Medical Center ( Site 0006) | 20007 | Washington D.C. | District of Columbia |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003) | 32804 | Orlando | Florida |
| Orlando Health, Inc. ( Site 0035) | 32806 | Orlando | Florida |
| University Cancer & Blood Center, LLC ( Site 0057) | 30607 | Athens | Georgia |
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