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NCT04017650 · ClinicalTrials.gov registry record · Phase 1
Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
A Phase 1 study of Stage III Colorectal Cancer AJCC v8 and Stage IIIA Colorectal Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04017650 is a Phase 1 study of Stage III Colorectal Cancer AJCC v8 and Stage IIIA Colorectal Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 38 participants, below the 126-participant average among 17 other Stage III Colorectal Cancer AJCC v8 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04017650, a Phase 1 study of Stage III Colorectal Cancer AJCC v8 and Stage IIIA Colorectal Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Encorafenib and cetuximab 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 encorafenib, cetuximab, and nivolumab may work better in treating patients with colorectal cancer compared to cetuximab alone.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- BIOLOGICAL Nivolumab
- DRUG Encorafenib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-06-14 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04017650
The ClinicalTrials.gov registry entry for NCT04017650 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 17 other Stage III Colorectal Cancer AJCC v8 trials with a reported enrollment target (70% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Stage III Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT04017650 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04017650 about?
NCT04017650 is a clinical study titled "Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer". This phase I/II trial studies the best dose and side effects of encorafenib, cetuximab, and nivolumab and how well they work together in treating patients with microsatellite stable, BRAFV600E gene mutated colorectal cancer that cannot be removed by surgery (unresectable) or has spread to other plac...
What is the current status of trial NCT04017650?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-06-14. Estimated completion is 2027-12-30.
What conditions does trial NCT04017650 study?
This clinical trial studies the following conditions: Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma.
What interventions are being tested in trial NCT04017650?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04017650?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04017650 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Stage III Colorectal Cancer AJCC v8
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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.