Study of Nivolumab and Axitinib for Patients with Advanced Kidney Cancer
Sponsor: Fox Chase Cancer Center
ClinicalTrials ID:NCT03172754
This clinical trial is testing a combination of two drugs, Nivolumab and Axitinib, to see if they are safe and effective for treating advanced kidney cancer. The study includes patients who have and have not received previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring the use of two drugs, Nivolumab and Axitinib, for treating advanced kidney cancer. It is divided into two parts: Phase I, which will determine the safest dose of the drug combination, and Phase II, which will test how well the combination works in patients who have and have not been treated before. The goal is to find out if this combination can help control the cancer.
Eligibility Criteria
Inclusion Criteria
- Have advanced kidney cancer with a specific type of cell structure.
- Provide a sample of tumor tissue if available.
- Have at least one tumor that can be measured by scans.
- Be 18 years or older.
- Be in good overall health, with a performance status score of 0 or 1.
- Have adequate blood cell counts and organ function, including:
- White blood cell count of at least 2000/μL.
- Neutrophil count of at least 1500/μL.
- Platelet count of at least 100,000/μL.
- Hemoglobin level above 9.0 g/dL.
- Normal kidney and liver function as indicated by specific blood tests.
- Have controlled blood pressure.
- If previously treated, must have received certain types of cancer therapy.
- If untreated, must not have received any prior therapy for advanced kidney cancer.
Exclusion Criteria
- Have previously been treated with Axitinib.
- Have received certain cancer treatments recently.
- Have active brain cancer that is causing symptoms.
- Have another type of cancer that requires treatment.
- Have an immune system disorder or are taking medications that suppress the immune system.
- Have had major surgery or radiation therapy recently.
- Have digestive issues that affect medication absorption.
- Have a bleeding disorder or recent significant bleeding.
- Have allergies to the study drugs.
- Are taking certain medications that interact with the study drugs.
- Have active infections like hepatitis B, hepatitis C, or HIV.
- Have had recent serious heart or blood clot issues.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Johns Hopkins | 21231 | Baltimore | Maryland |
| US Oncology and Hematology | 12206 | Albany | New York |
| Cornell | 10021 | New York | New York |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
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