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

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

• Neoplasms

Interventions

DRUG

Encorafenib

75 mg capsules

DRUG

Cetuximab

Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial

DRUG

Oxaliplatin

Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial

DRUG

Irinotecan

Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial

DRUG

Leucovorin

Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial

DRUG

5-FU

Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial

DRUG

Capecitabine

150 mg or 500 mg Tablet

DRUG

Bevacizumab

Optional Injection for intravenous use 100 mg/vial or 400 mg/vial

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd

  collaborator INDUSTRY

• Merck KGaA, Darmstadt, Germany

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-21

Primary Completion

2025-12-08

Completion

2027-12-28

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Bulgaria
• Canada
• China
• Czechia
• Denmark
• Finland
• Germany
• India
• Italy
• Japan
• Mexico
• Netherlands
• New Zealand
• Norway
• Poland
• Russia
• Slovakia
• South Africa
• South Korea
• Spain
• Sweden
• Taiwan
• Ukraine
• United Kingdom

Study Locations