A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Summary

This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.

Conditions

• Colorectal Cancer

Interventions

DRUG

Cetuximab

500 mg/m\^2 via IV infusion on Day 1 of every 2-week cycle

DRUG

FOLFOX induction regimen

Administered per the Investigator's discretion in accordance with locally approved prescribing information.

DRUG

Fluoropyrimidine (5-FU/LV or capecitabine)

Per Investigator's discretion: 5-FU 1600-2400 mg/m\^2 administered via 46-hour IV infusion on Day 1 of every 2-week cycle and LV 400 mg/m\^2 administered via a 2-hour infusion on Day 1 every 2 weeks or 1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The chosen fluoropyrimidine should be administered in accordance with local prescribing information.

DRUG

Atezolizumab

800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle, or a fixed dose of 840 mg

DRUG

Vemurafenib

960 mg vermurafenib BID by mouth

DRUG

Bevacizumab

5 mg/kg bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle per local prescribing information

DRUG

Trastuzumab

Initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses by IV infusion on Day 1 of every 3-week treatment cycle

DRUG

Pertuzumab

Initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses by IV infusion on Day 1 of each 3-week treatment cycle

DRUG

Cobimetinib

60 mg orally once daily for 3 weeks followed by a 1-week treatment break

DRUG

5-FU/LV

1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle until disease progression per the Investigator's assessment using modified Response Evaluation Criteria in Solid Tumors or death from any cause, whichever occurs first. The fluoropyrimidine should be administered in accordance with local prescribing information.

DRUG

Capecitabine

1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The fluoropyrimidine should be administered in accordance with local prescribing information.

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-17

Primary Completion

2019-05-31

Completion

2021-03-24

Countries

• Argentina
• Belgium
• Bosnia and Herzegovina
• Brazil
• Denmark
• Egypt
• France
• Germany
• Greece
• Italy
• Mexico
• Netherlands
• Poland
• Portugal
• Russia
• Serbia
• Slovakia
• Slovenia
• South Korea
• Spain
• Sweden
• Turkey (Türkiye)
• United Kingdom

Study Locations