Last updated on November 2019

Axitinib and Nivolumab in Treating Patients With Unresectable or Metastatic TFE/Translocation Renal Cell Carcinoma


Brief description of study

This phase II trial studies how well axitinib and nivolumab works in treating patients with TFE/translocation renal cell carcinoma that cannot be removed by surgery or has spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating patients with TFE/translocation renal cell carcinoma compared to standard treatment, including surgery, chemotherapy, or immunotherapy.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To establish the clinical activity of axitinib and/or nivolumab therapy for advanced transcription factor E3/translocation morphology renal cell carcinoma (TFE/tRCC).

SECONDARY OBJECTIVES:

I. To further define the toxicities of the study arms in the treatment of translocation morphology RCC across all ages.

EXPLORATORY OBJECTIVES:

I. To characterize tRCC clinical behavior across all age groups. II. To evaluate type of antitumor immune response and stability of T cell activation before and after treatment with immunotherapy or antiangiogenic therapy.

III. To develop a tumor bank of tRCC tumor samples treated on study for further biological investigations.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (IV) over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and every 6 months for 2 years. Follow-up at year 5 and beyond is at the discretion of the treating physician.

Clinical Study Identifier: NCT03595124

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