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NCT03595124 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
15
Enrollment target
20
Study locations

NCT03595124: Active Phase 2 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

NCT03595124 is a Phase 2 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants, below the 143-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03595124, a Phase 2 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
15 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

The Kaplan-Meier method will be used to estimate 1-year PFS, defined as the time from randomization to disease progression or death due to any cause. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.

Conditions Studied

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

Interventions

  • BIOLOGICAL Nivolumab
  • DRUG Axitinib

Study Locations (20)

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • PCR Oncology - Arroyo Grande
  • Kaiser Permanente-Bellflower - Bellflower
  • Mercy Cancer Center - Carmichael - Carmichael
  • Mercy San Juan Medical Center - Carmichael
  • Kaiser Permanente Downey Medical Center - Downey
  • Mercy Cancer Center - Elk Grove - Elk Grove
  • Kaiser Permanente-Fontana - Fontana
  • Kaiser Permanente Los Angeles Medical Center - Los Angeles
  • Mattel Children's Hospital UCLA - Los Angeles
  • Kaiser Permanente-Oakland - Oakland
  • Children's Hospital of Orange County - Orange
  • Mercy Cancer Center - Rocklin - Rocklin
  • Mercy Cancer Center - Sacramento - Sacramento

Arizona

  • CTCA at Western Regional Medical Center - Goodyear
  • Cancer Center at Saint Joseph's - Phoenix

Arkansas

  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • Arkansas Children's Hospital - Little Rock

Alabama

  • Children's Hospital of Alabama - Birmingham

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-01-08
Est. Completion 2026-11-13
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03595124 still lists

NCT03595124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 143-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (90% lower).

The record links to 5 conditions, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT03595124 names 20 study sites across 4 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT03595124 about?

NCT03595124 is a clinical study titled "A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)". 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 t...

What is the current status of trial NCT03595124?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-01-08. Estimated completion is 2026-11-13.

What conditions does trial NCT03595124 study?

This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Unresectable Renal Cell Carcinoma, TFE3-Rearranged Renal Cell Carcinoma.

What interventions are being tested in trial NCT03595124?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Axitinib (DRUG).

Who is sponsoring clinical trial NCT03595124?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03595124 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03595124's enrollment target sits among peer trials

15 36th of 37 higher than 2 of 37 other Metastatic Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03595124, the US trial registry maintained by the National Library of Medicine. NCT03595124 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.