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Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
NCT04510597 · View on ClinicalTrials.gov ↗
Study Summary
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Conditions Studied
Interventions
- DRUG Active Comparator
- PROCEDURE Cytoreductive Nephrectomy
Study Locations (20)
California
- PCR Oncology — Arroyo Grande
- Sutter Auburn Faith Hospital — Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
- Keck Medicine of USC Buena Park — Buena Park
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
- Eden Hospital Medical Center — Castro Valley
- Sutter Davis Hospital — Davis
- City of Hope Comprehensive Cancer Center — Duarte
- Palo Alto Medical Foundation-Fremont — Fremont
- Keck Medicine of USC Huntington Beach — Huntington Beach
- Keck Medicine of USC Koreatown — Los Angeles
- Los Angeles County-USC Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Kingman Regional Medical Center — Kingman
- Banner University Medical Center - Tucson — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2033-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04510597
The ClinicalTrials.gov registry entry for NCT04510597 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 364 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Active Comparator 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: NCT04510597 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 NCT04510597 about?
NCT04510597 is a clinical study titled "Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial". This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy w...
What is the current status of trial NCT04510597?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 364 participants. The study started on 2021-03-08. Estimated completion is 2033-07.
What conditions does trial NCT04510597 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Metastatic Clear Cell 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 NCT04510597?
The interventions under investigation include: Active Comparator (DRUG), Cytoreductive Nephrectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04510597?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04510597 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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