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About
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Signed cohort-specific Informed Consent Form
Age >= 18 years at time of signing Informed Consent Form
Biomarker eligibility as determined by:
Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1
Life expectancy >= 3 months, as determined by the investigator
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease
Prior therapies for metastatic disease
Ability to comply with the study protocol, in the investigators judgment
Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
542 participants in 10 patient groups
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Central trial contact
Reference Study ID Number: WO42758 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
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