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Tyrosine Kinase Inhibitor

Nivolumab + Axitinib for Kidney Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Histologically or cytologically confirmed advanced RCC with predominantly clear cell subtype

Must not have

Patients with active, symptomatic brain metastases or leptomeningeal metastases

Patients with a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of initiation of treatment to death or when the patient is lost to follow up, approximately 25 months on average

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat advanced renal cell carcinoma in both previously treated and untreated patients. The first part of the trial will establish a safe and tolerable dose, and the second part will test the efficacy of the combination at that dose.

Who is the study for?

Adults over 18 with advanced kidney cancer, specifically clear cell renal cell carcinoma. Participants can be new to treatment or have had previous therapy but must have measurable cancer lesions and good organ function. They should not have uncontrolled high blood pressure, autoimmune diseases, recent major surgery or radiation, active infections like HIV/HBV/HCV, or be pregnant.

What is being tested?

The study is testing the combination of Nivolumab (an immunotherapy drug) and Axitinib (a medication that inhibits blood vessel growth in tumors) in patients with advanced kidney cancer. It includes a Phase I part to find safe doses and a Phase II part to test effectiveness in both new and previously treated patients.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, high blood pressure due to Axitinib, fatigue, liver issues especially if combined with other hepatotoxic drugs, bleeding disorders might worsen; specific allergies to components of the drugs are also concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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My kidney cancer is mainly of the clear cell type.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active brain or spinal cord cancer symptoms.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have no major issues with my digestive system.

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I have been diagnosed with an immune system disorder.

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I haven't had major surgery in the last 4 weeks or radiation therapy in the last 2 weeks.

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I am currently receiving treatment for another cancer.

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I am using or might need strong CYP3A4/5 inducer drugs.

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I have been diagnosed with HIV/AIDS.

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I haven't had cancer treatment or radiation in the last 14 days.

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I have been treated with axitinib before.

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I am using or might need strong CYP3A4/5 inhibitors.

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I have hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of initiation of treatment to death or when the patient is lost to follow up, approximately 25 months on average

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of initiation of treatment to death or when the patient is lost to follow up, approximately 25 months on average

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of initiation of treatment to death or when the patient is lost to follow up, approximately 25 months on average for reporting.