Clinical trialNCT03595124Active, not recruitingPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment15Metastatic Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8TFE3-Rearranged Renal Cell CarcinomaUnresectable Renal Cell Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

James I Geller
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

267 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

Hima San Pablo Oncologic Hospital
Caguas, Puerto Rico

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Ctca at Western Regional Medical Center
Goodyear, Arizona, United States
Cancer Center at Saint Joseph'S
Phoenix, Arizona, United States
Chi Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Pcr Oncology
Arroyo Grande, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Mattel Children'S Hospital Ucla
Los Angeles, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-Rio San Diego
San Diego, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Uchealth University of Colorado Hospital
Aurora, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, United States
Adventhealth Porter
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke'S Medical Center
Denver, Colorado, United States
Commonspirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Mountain Blue Cancer Care Center
Golden, Colorado, United States
Commonspirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Adventhealth Littleton
Littleton, Colorado, United States

227 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Axitinib →Nivolumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Jan 2019
Primary completion: 30 Sept 2024
Completion: 13 Nov 2026
Last update posted: 22 Oct 2026
Registered enrollment: 15
Registry id: NCT03595124

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.