NCT 05253651
Brief Summary
This study is being done to find out if tucatinib with other cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs drugs works better than standard of care to treat participants with HER2 positive colorectalrelating to the colon or rectum in the large bowel/intestine cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effectan unintended effect of medication or treatment, is often negative or unwanted 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 surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence (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.
Intervention / Treatment
- Drug: tucatinib
- Drug: trastuzumab
- Drug: bevacizumab
- Drug: cetuximab
- Drug: oxaliplatin
- Drug: leucovorin
- Drug: levoleucovorin
- Drug: fluorouracil
Inclusion Criteria:
- Histologically and/or cytologically confirmed adenocarcinomacancer arising from mucus-producing glands in organs of the colonthe longest portion of the large bowel that absorbs water and salts from ingested food or rectumthe last section of the large intestine/bowel that holds waste until it is ready to be removed from the body which is locally advancedat a late stage, far along unresectable or metastatic
- Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissuea group of cells that work together to perform a function blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
- If archival tissue is not available, a newly-obtained baseline biopsyremoval of a section of tissue to analyse for cancer cells 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 sarcomacancer arising from bones and/or soft tissue 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 or 1
- CNS Inclusion – based on contrast brain magnetic resonance imagingtests that create detailed images of areas inside the body, participants may have any of the following:
- No evidence of brain metastases
- Previously treated brain metastases which are asymptomatic