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A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

NCT04607421

Active Not RecruitingPhase 3

Sponsor: Pfizer

Conditions: Neoplasms

Interventions: Encorafenib, Cetuximab, Oxaliplatin, Irinotecan, Leucovorin

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Safety Lead-In = Male/female ≥ 18 years old
* Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
* Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
* Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis \< 6 month from end of adj/neoadjuvant treatment )
* Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
* ECOG PS 0-1
* Adequate organ function

Exclusion Criteria:

* Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
* Active bacterial or viral infections in 2 weeks prior to starting dosing
* Symptomatic brain metastases

Locations (272)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Aventura, Florida, United States
Miami Beach, Florida, United States
Miami Beach, Florida, United States
Plantation, Florida, United States
Plantation, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Flossmoor, Illinois, United States
Harvey, Illinois, United States
New Lenox, Illinois, United States
Orland Park, Illinois, United States
Tinley Park, Illinois, United States
New Orleans, Louisiana, United States
Rochester, Minnesota, United States
City of Saint Peters, Missouri, United States
Creve Coeur, Missouri, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
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