Study on Nivolumab and Cabozantinib for Patients with Non-Clear Cell Kidney Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT03635892
This clinical trial is exploring the effects of combining two drugs, nivolumab and cabozantinib, to treat patients with advanced kidney cancer that has spread. The study aims to understand both the benefits and side effects of this treatment combination.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to see how well a combination of two drugs, nivolumab (Opdivo®) and cabozantinib (Cabometyx®), works in treating people with advanced kidney cancer that cannot be removed by surgery. Researchers want to find out if this combination can help control the cancer and what side effects it might cause.
Eligibility Criteria
Inclusion Criteria
- Must sign a consent form to participate.
- Have advanced kidney cancer that cannot be surgically removed.
- Have had 0 or 1 prior treatments for kidney cancer.
- Provide a tumor sample for diagnosis.
- Have measurable cancer as per standard criteria.
- Be 18 years or older.
- Have a performance status score of 70 or higher, indicating the ability to care for oneself.
- Have recovered from any side effects of previous treatments.
- Have adequate blood and organ function based on specific lab tests.
- Women of childbearing potential must agree to use effective birth control during the study and for a period after.
- Men must agree to use birth control during the study and for a period after.
- Must not be pregnant at the start of the study.
- Must understand and agree to follow the study requirements.
Exclusion Criteria
- Have had previous treatment with certain immunotherapy drugs or cabozantinib.
- Have received certain cancer treatments recently.
- Have cancer in the brain or spinal cord.
- Require ongoing pain medication that is not stable.
- Are taking high doses of steroids or other immune-suppressing drugs.
- Have uncontrolled fluid buildup in the body.
- Have high calcium levels that are not controlled.
- Have had another cancer within the last 2 years, except for certain skin cancers.
- Are pregnant or breastfeeding.
- Have severe allergies to similar drugs.
- Have HIV or active hepatitis B or C.
- Have significant heart disease or uncontrolled high blood pressure.
- Have had major surgery recently.
- Have had a stroke or significant vascular disease recently.
- Have bleeding disorders or significant bleeding history.
- Have gastrointestinal issues that require special feeding.
- Have a history of abdominal issues like fistulas or perforations.
- Have other serious health conditions that could affect participation.
- Cannot swallow pills.
- Have a history of not following medical advice.
- Are taking certain blood thinners that are not allowed in the study.
- Have significant bleeding or blood in urine or vomit recently.
- Have tumors affecting major blood vessels or the gastrointestinal tract.
- Have had recent radiation therapy that could affect participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
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