A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Summary

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).

Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Conditions

• Colorectal Neoplasms

Interventions

DRUG

tucatinib

300mg given by mouth (orally) twice daily

DRUG

trastuzumab

8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.

DRUG

bevacizumab

5mg/kg given by IV every 2 weeks

DRUG

cetuximab

400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly

DRUG

oxaliplatin

85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

DRUG

leucovorin

400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

DRUG

levoleucovorin

200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.

DRUG

fluorouracil

400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.

Sponsors & Collaborators

• Seagen, a wholly owned subsidiary of Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-24

Primary Completion

2026-04-03

Completion

2029-07-27

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• China
• France
• Germany
• Greece
• Ireland
• Italy
• Japan
• Netherlands
• Norway
• Poland
• Portugal
• Slovakia
• South Korea
• Spain
• Switzerland
• Taiwan
• United Kingdom

Study Locations