Comparing 10 approaches for metastatic colorectal cancer

Inclusion

• +Symptomatic, untreated, or actively progressing CNS metastases
• +History of leptomeningeal disease or carcinomatous meningitis
• +Negative HIV test at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
• +Signed cohortCohortA group of participants sharing a characteristic, followed together.Read more →-specific Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• +Age \>= 18 years at time of signing Informed Consent Form
• +BiomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → as determined by:
• +A validated test approved by local health authorities for detection of the specified biomarkers/mutations.
• +A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.
• +Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR
• +Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → after treatment discontinuation, prior to starting a new anti-cancer therapy.
• +Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1
• +Life expectancy \>= 3 months, as determined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• +Histologically confirmed adenocarcinoma originating from the colon or rectum
• +Metastatic disease
• +Prior therapies for metastatic disease
• +Ability to comply with the study protocolProtocolThe detailed plan a study must follow.Read more →, 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)
• +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 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
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Current participation or enrollment in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical trial. Participants who are participating in the follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → of an interventional clinical trial are eligible for the study.
• +Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
• +Treatment with investigational therapy within 28 days prior to initiation of study treatment
• +History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study
• +Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
• +Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
• +Uncontrolled tumor-related pain
• +Uncontrolled or symptomatic hypercalcemia
• +Clinically significant and active liver disease
• +History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• +Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
• +Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications
• +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
• +Pregnant or breastfeeding, or intending to become pregnant during the study
• +Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment