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A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
NCT03595124 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03595124 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03595124?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Axitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03595124?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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