Study on Cabozantinib with Nivolumab and Ipilimumab for Untreated Advanced or Metastatic Kidney Cancer
Sponsor: Exelixis
ClinicalTrials ID:NCT03937219
This clinical trial is testing a new combination of drugs, cabozantinib with nivolumab and ipilimumab, to see if it can help patients with advanced or metastatic kidney cancer live longer without the disease getting worse.
Patient Parameters
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Program Overview
This study is exploring whether a combination of three drugs—cabozantinib, nivolumab, and ipilimumab—can help patients with advanced kidney cancer live longer without their cancer progressing. The trial will compare this combination to the standard treatment of nivolumab and ipilimumab with a placebo. About 840 patients with intermediate or poor-risk advanced kidney cancer will participate in this study at around 180 locations.
Description
This clinical trial is designed to test the effectiveness of a new drug combination for treating advanced kidney cancer. The study will compare the effects of cabozantinib combined with nivolumab and ipilimumab against the standard treatment of nivolumab and ipilimumab with a placebo. The main goal is to see if the new combination can help patients live longer without their cancer getting worse. Another goal is to see if it can improve overall survival rates. Participants will be randomly assigned to receive either the new combination or the standard treatment, and neither the participants nor the researchers will know which treatment is being given to ensure unbiased results.
Eligibility Criteria
Inclusion Criteria
- Have advanced kidney cancer that cannot be treated with surgery or radiation, or cancer that has spread to other parts of the body.
- Classified as intermediate or poor-risk based on specific medical criteria.
- Have measurable cancer that can be tracked using standard criteria.
- Be in good overall health with a performance status score of 70% or higher.
- Have adequate organ and bone marrow function.
Exclusion Criteria
- Have received previous treatment for advanced kidney cancer.
- Have had recent radiation therapy for bone metastasis or other areas.
- Have untreated or unstable brain metastases.
- Are taking blood thinners or certain other medications.
- Have received a live vaccine recently.
- Have uncontrolled high blood pressure or other serious health conditions.
- Have active autoimmune diseases or require high doses of steroids or other immune-suppressing drugs.
- Have active infections like hepatitis, HIV, or tuberculosis.
- Have had major surgery recently without complete healing.
- Have another active cancer or have been treated for another cancer within the last three years, except for certain skin cancers or other localized cancers that have been cured.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Exelixis Clinical Site #116 | 92093 | La Jolla | California |
| Exelixis Clinical Site #166 | 92868-3201 | Orange | California |
| Exelixis Clinical Site #29 | 33486 | Boca Raton | Florida |
| Exelixis Clinical Site #44 | 33176 | Miami | Florida |
| Exelixis Clinical Site #3 | 30318 | Atlanta | Georgia |
| Exelixis Clinical Site #95 | 60612 | Chicago | Illinois |
| Exelixis Clinical Site #69 | 04074 | Scarborough | Maine |
| Exelixis Clinical Site #58A | 21287 | Baltimore | Maryland |
| Exelixis Clinical Site #7B | 02114 | Boston | Massachusetts |
| Exelixis Clinical Site #7A | 02215 | Boston | Massachusetts |
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