A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    220
  • sponsor
    Hoffmann-La Roche
Updated on 2 July 2022

Summary

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.

Details
Condition Metastatic Colorectal Cancer
Treatment Cetuximab, bevacizumab, Atezolizumab, Tiragolumab, SY-5609, Inavolisib
Clinical Study IdentifierNCT04929223
SponsorHoffmann-La Roche
Last Modified on2 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed next-generation sequencing (NGS) Biomarker Eligibility Informed Consent Form
Age >= 18 years at time of signing Informed Consent Form
Biomarker eligibility as determined at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited diagnostic laboratory using a validated test
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)
Availability of an archival tissue sample for exploratory biomarker research
Adequate hematologic and organ function within 14 days prior to initiation of study treatment
For women of childbearing potential: Must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment and agreement to remain abstinent or use contraceptive measures
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

Current participation or enrollment in another interventional clinical trial
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
Pregnant or breastfeeding, or intending to become pregnant during the study
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
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
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
Known HIV infection
Symptomatic, untreated, or actively progressing CNS metastases
History of leptomeningeal disease or carcinomatous meningitis
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 patient 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 patient compliance, or puts the patient at higher risk for treatment-related complications
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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