Trials / Active Not Recruiting

Active Not RecruitingNCT03595124

A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 15 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 12 Months
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well axitinib and nivolumab work in treating patients with TFE/translocation renal cell carcinoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). 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 description

PRIMARY OBJECTIVE: I. To establish the clinical activity, assessed primarily by progression-free survival, of nivolumab therapy with or without axitinib for advanced transcription factor E3/translocation morphology renal cell carcinoma (TFE/tRCC). SECONDARY OBJECTIVE: 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. IV. To characterize the pharmacokinetics of axitinib when given in combination with nivolumab in pediatric patients with tRCC. OUTLINE: Patients are now randomized to 1 of 2 arms - Arm A or Arm C. ARM A: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). 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. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C) ARM C: Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). 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.

Conditions

Interventions

Type	Name	Description
DRUG	Axitinib	Given PO
BIOLOGICAL	Nivolumab	Given IV

Timeline

Start date: 2019-01-08
Primary completion: 2024-09-30
Completion: 2026-11-13
First posted: 2018-07-23
Last updated: 2025-12-03
Results posted: 2025-10-10

Locations

269 sites across 2 countries: United States, Puerto Rico

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03595124. Inclusion in this directory is not an endorsement.