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NCT04510597 · ClinicalTrials.gov registry record · Phase 3
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
A Phase 3 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 364
- Enrollment target
- 20
- Study locations
NCT04510597 is a Phase 3 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 364 participants, above the 133-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (174% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT04510597, a Phase 3 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 364 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 364 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 133-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (174% higher). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
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.
NCT04510597 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT04510597?
The interventions under investigation include: Active Comparator (DRUG), Cytoreductive Nephrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04510597?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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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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.