Study on Encorafenib and Cetuximab With or Without Chemotherapy for Untreated Metastatic Colorectal Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT04607421
This clinical trial is testing two medications, encorafenib and cetuximab, alone or with chemotherapy, to treat colorectal cancer that has spread and has a specific BRAF gene mutation. The study aims to find out if these treatments can improve outcomes compared to standard chemotherapy.
Patient Parameters
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Program Overview
The study is exploring whether a combination of two drugs, encorafenib and cetuximab, with or without standard chemotherapy, can effectively treat colorectal cancer that has spread to other parts of the body and has a specific BRAF gene mutation. Participants will receive one of the following treatments: encorafenib and cetuximab alone, encorafenib and cetuximab with chemotherapy, or chemotherapy alone. The study will monitor participants' responses to these treatments for up to three years.
Description
This study aims to determine if the combination of encorafenib and cetuximab, with or without chemotherapy, can improve treatment outcomes for people with metastatic colorectal cancer that has a BRAF V600E mutation and has not been treated before. The study will first test the safety and how the body processes these drugs when combined with different chemotherapy regimens to decide which combination to use in the main part of the study. Participants will be monitored to see how well they respond to the treatments over time.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older for the initial safety phase; 16 or older for the main study, depending on local regulations.
- Diagnosed with Stage IV colorectal cancer with a BRAF V600E mutation.
- No previous treatment for metastatic cancer, except for certain cases where previous treatment was given and the cancer returned within six months.
- Have measurable cancer that can be tracked during the study.
- In good general health with an ECOG performance status of 0 or 1.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Tumors with certain genetic features (MSI-H or dMMR) unless the participant cannot receive immune therapy due to other health conditions.
- Active infections within two weeks before starting the study treatment.
- Cancer that has spread to the brain and is causing symptoms.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona - Scottsdale | 85259 | Scottsdale | Arizona |
| Keck Hospital of USC | 90033 | Los Angeles | California |
| LAC & USC Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC/Norris Comprehensive Cancer Center/Investigational Drug Services | 90033 | Los Angeles | California |
| USC/Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Keck Hospital of USC Pasadena | 91105 | Pasadena | California |
| Mount Sinai Comprehensive Cancer Center, Aventura | 33180 | Aventura | Florida |
| Mount Sinai Comprehensive Cancer Center | 33140 | Miami Beach | Florida |
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