Comparing tucatinib with bevacizumab for colorectal neoplasms
Official title: A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
Interventions
tucatinib
300mg given by mouth (orally) twice daily
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.
bevacizumab
5mg/kg given by IV every 2 weeks
cetuximab
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
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.
Canadian Sites (5)
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +No evidence of brain metastases
- +Previously treated brain metastases which are asymptomatic
- +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 baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 siteTrial siteA hospital or clinic where a study is actually run.Read more → of disease that is measurable and that has not been previously irradiated, or
- +Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- +CNS InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → - based on contrast brain magnetic resonance imaging, participants may have any of the following:
- +If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
Exclusion
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Previous treatment with anti-HER2 therapy
- −Ongoing Grade 3 or higher neuropathy
- −Active or untreated gastrointestinal (GI) perforation at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: tucatinib, trastuzumab, bevacizumab, cetuximab, and 4 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 400 people.
The study is currently expected to finish around July 2030.
The main measurement is taken over: Up to approximately 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR) — measured over Up to approximately 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05253651 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About tucatinibDrug
300mg given by mouth (orally) twice daily
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About trastuzumabDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About bevacizumabDrug
5mg/kg given by IV every 2 weeks
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About cetuximabDrug
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About oxaliplatinDrug
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About leucovorinDrug
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About levoleucovorinDrug
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About fluorouracilDrug
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 3 years.
The study as a whole is currently expected to finish around 2030-07-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 22 locations, including: Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Saskatoon, Saskatchewan, Canada; Burnsville, Minnesota, United States; Coon Rapids, Minnesota, United States, and 16 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (28)
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, United States
Allina Health Cancer institute
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, United States
M Health Fairview Cancer Clinic-Edina
Edina, Minnesota, United States
Minnesota Oncology Hematology, PA
Edina, Minnesota, United States
Minnesota Oncology Hematology, PA
Fridley, Minnesota, United States
Minnesota Oncology Hematology, PA
Maple Grove, Minnesota, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, United States
Allina Health Cancer Institute (Virginia Piper Cancer Institute)
Minneapolis, Minnesota, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Health Cancer Center
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
Regulatory Location: MMCORC
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Allina Health Cancer Institute-United(VPCI)
Saint Paul, Minnesota, United States
Minnesota Oncology Hematology, PA Cornerstone Medical Specialty Center
Woodbury, Minnesota, United States
And 8 more sites worldwide.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.