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NCT04981509 · ClinicalTrials.gov registry record · Phase 2
Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer
A Phase 2 study of Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 13
- Study locations
NCT04981509: Recruiting Phase 2 study of Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04981509 is a Phase 2 study of Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (73% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04981509, a Phase 2 study of Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 13
- Study locations
Study Summary
This phase II trial studies the effects of combination therapy with bevacizumab, erlotinib, and atezolizumab in treating patients with hereditary leiomyomatosis and kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Bevacizumab is in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Combination therapy with bevacizumab, erlotinib, and atezolizumab may stabilize or shrink advanced hereditary leiomyomatosis and kidney cancer.
Primary Outcome
To determine the safety and tolerability of the combination of bevacizumab, erlotinib, and atezolizumab, the fraction of patients with a dose-limiting toxicity will be reported, along with the maximum grade and type of toxicity for each type noted. Note: In addition to adverse events in the entire study population, pediatric toxicities will also be reported and analyzed separately.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Atezolizumab
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
- BIOLOGICAL Bevacizumab
Study Locations (13)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Maryland
- National Institutes of Health Clinical Center - Bethesda
- NCI - Center for Cancer Research - Bethesda
New York
- NYU Langone Hospital - Long Island - Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
California
- UC San Diego Moores Cancer Center - La Jolla
Illinois
- Northwestern University - Chicago
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-06-10 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT04981509 shows while recruiting
NCT04981509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (73% lower).
The record links to 6 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04981509 lists 13 locations in 9 states (Georgia, Maryland, New York).
Frequently Asked Questions
What is clinical trial NCT04981509 about?
NCT04981509 is a clinical study titled "Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer". This phase II trial studies the effects of combination therapy with bevacizumab, erlotinib, and atezolizumab in treating patients with hereditary leiomyomatosis and kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). ...
What is the current status of trial NCT04981509?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2022-06-10. Estimated completion is 2027-12-31.
What conditions does trial NCT04981509 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Papillary Renal Cell Carcinoma, Hereditary Leiomyomatosis and Renal Cell Carcinoma.
What interventions are being tested in trial NCT04981509?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Atezolizumab (BIOLOGICAL), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04981509?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04981509 being conducted?
This trial has 13 study locations across California, Georgia, Illinois, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04981509's enrollment target sits among peer trials
65 69th of 121 higher than 53 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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