Combination treatment for HER2 positive metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of tucatinib combined with trastuzumab and mFOLFOX6 compared to standard care treatments for patients with HER2 positive metastatic colorectal cancer. Participants will be randomly assigned to receive either the combination therapy or standard treatments, which may include mFOLFOX6 alone or with other agents like bevacizumab or cetuximab. The study aims to assess both the efficacy of the new treatment regimen and the side effects experienced by participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory

  * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
* HER2+ disease as determined by a tissue based assay performed at a central laboratory.
* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
* Radiographically measurable disease per RECIST v1.1 with:

  * At least one site of disease that is measurable and that has not been previously irradiated, or
  * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:

  * No evidence of brain metastases
  * Previously treated brain metastases which are asymptomatic

Exclusion Criteria:

* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.

  * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollment
* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
* Previous treatment with anti-HER2 therapy
* Ongoing Grade 3 or higher neuropathy
* Active or untreated gastrointestinal (GI) perforation at the time of screening.

Where it's running

• Palo Verde Hematology Oncology
  Glendale, Arizona, United States Recruiting
• Mayo Clinic Building - Phoenix
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• Los Angeles Cancer Network - Anaheim
  Anaheim, California, United States Recruiting
• Los Angeles Cancer Network - Fountain Vally
  Fountain Valley, California, United States Recruiting

+316 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Petosemtamab plus chemotherapy vs standard chemo plus cetuximab or bevacizumab in RAS/BRAF WT colorectal cancer

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• Bevacizumab, sintilimab, cetuximab and irinotecan in refractory RAS wild-type metastatic colorectal cancer

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• Second-line combination treatment for MSS metastatic colorectal cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.