Nivolumab + Axitinib for Kidney Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Fox Chase Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

My kidney cancer is mainly of the clear cell type.

I am fully active or can carry out light work.

Exclusion Criteria

I have active brain or spinal cord cancer symptoms.

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

I have no major issues with my digestive system.

I have been diagnosed with an immune system disorder.

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

I am currently receiving treatment for another cancer.

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

I have been diagnosed with HIV/AIDS.

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

I have been treated with axitinib before.

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

I have hepatitis B or C.

Treatment Details

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.

3Treatment groups

Experimental Treatment

Group I: Phase II patients: cohort 2Experimental Treatment2 Interventions

Phase II cohort 2 patients must not have received prior systemic therapy for advanced RCC.

Group II: Phase II patients: cohort 1Experimental Treatment2 Interventions

Phase II cohort 1 patients must have received at least 1 prior tyrosine kinase inhibitor for RCC.

Group III: Phase I patientsExperimental Treatment2 Interventions

Phase I patients must have received at least 1 prior tyrosine kinase inhibitor for RCC.

Axitinib is already approved in European Union, United States, United Kingdom for the following indications:

🇪🇺 Approved in European Union as Inlyta for: