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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-01-08 |
| Est. Completion | 2026-11-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03595124
The ClinicalTrials.gov registry entry for NCT03595124 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (90% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.