OncRef

Clinical Trial: NCT03595124

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-01

Study Overview

Brief 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.

Official Title

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

Conditions

Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, TFE3-Rearranged Renal Cell Carcinoma, Unresectable Renal Cell Carcinoma

Intervention / Treatment

  • Drug: Axitinib
  • Biological: Nivolumab

Other Study ID Numbers

  • NCI-2018-01489
  • NCI-2018-01489
  • AREN1721
  • AREN1721
  • U10CA180886

Start Date (Actual)

2019-01-08

Primary Completion Date (Actual)

2024-09-30

Study Completion Date (Estimated)

2026-11-13

Enrollment (Actual)

15

Study Type

Interventional

Phase

Phase 2