Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04607421 · ClinicalTrials.gov registry record · Phase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
A Phase 3 study of Neoplasms, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 831
- Enrollment target
- 20
- Study locations
NCT04607421 is a Phase 3 study of Neoplasms that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 831 participants, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT04607421, a Phase 3 study of Neoplasms, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 831 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 831 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (49% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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.
NCT04607421 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Illinois, California, Florida.
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.
What interventions are being tested in trial NCT04607421?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG), Irinotecan (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04607421?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Neoplasms
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.
-
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
ACTIVE NOT RECRUITING · Phase 3
-
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
COMPLETED · Phase 3
-
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
COMPLETED · Phase 3
-
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
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.