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A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
NCT04607421 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Cetuximab
- DRUG Irinotecan
- DRUG Encorafenib
Study Locations (20)
Illinois
- UChicago Medicine - River East — Chicago
- University of Chicago Medical Center — Chicago
- UChicago Medicine at Ingalls - Flossmoor — Flossmoor
- UChicago Medicine Ingalls Memorial — Harvey
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital — New Lenox
- The University of Chicago Medicine Center for Advanced Care Orland Park — Orland Park
- UChicago Medicine at Ingalls - Tinley Park — Tinley Park
California
- Keck Hospital of USC — Los Angeles
- LAC & USC Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- USC/Norris Comprehensive Cancer Center/Investigational Drug Services — Los Angeles
- USC/Norris Comprehensive Cancer Center — Los Angeles
- Keck Hospital of USC Pasadena — Pasadena
Florida
- Mount Sinai Comprehensive Cancer Center, Aventura — Aventura
- Mount Sinai Comprehensive Cancer Center — Miami Beach
- Mount Sinai Medical Center — Miami Beach
- BRCR Global — Plantation
- BRCR Medical Center Inc. — Plantation
Arizona
- Mayo Clinic Hospital — Phoenix
- Mayo Clinic in Arizona - Scottsdale — Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 831 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2027-12-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04607421
The ClinicalTrials.gov registry entry for NCT04607421 describes a study currently listed as active not 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 831 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Leucovorin 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: NCT04607421 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Illinois, California, Florida. 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 NCT04607421 about?
NCT04607421 is a clinical study titled "A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer". The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRA...
What is the current status of trial NCT04607421?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 831 participants. The study started on 2020-12-21. Estimated completion is 2027-12-28.
What conditions does trial NCT04607421 study?
This clinical trial studies the following conditions: Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04607421?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG), Irinotecan (DRUG), Encorafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04607421?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04607421 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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