MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of the study is to determine the feasibility of generating sufficient MicroOrganoSpheres (MOS) from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and completing a drug screen against patient-derived MOS using standard of care drugs used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab) in ≤ 14 days.

Official Title
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MicroOrganoSphere Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Device: MicroOrganoSphere (MOS) drug screen


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject signed a valid, Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form. Male or female age 18 or older when written informed consent is obtained. Study candidate is willing and able to comply with all protocol-required procedures and assessments. Study candidate either is scheduled for or plans to be scheduled for a biopsy of the liver OR has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver. Key Exclusion Criteria: If already scheduled for a biopsy of the liver: liver biopsy was ordered to help diagnose, determine the severity of, or treat a disease that is unrelated to colorectal cancer (e.g., nonalcoholic fatty liver disease, chronic hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, etc.). Study candidate is participating (or intends to participate) in another clinical study AND either: is currently receiving investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver as part of that study OR that study only allows investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver (simultaneous participation in a clinical trial standard of care control arm is allowed, provided the subject is either already randomized or may be randomized to the control arm). Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic colorectal cancer<br>Patients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver. | Device: MicroOrganoSphere (MOS) drug screen<br>* Patient-derived models of cancer, called MOS, will be generated from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and a drug screen using standard-of-care drugs used will be completed (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab). Subjects will receive standard-of-care therapy for CRC dictated by their treating physicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOS generation | Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis | <14 Days from start of MOS generation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Metastasis, Colorectal Cancer, Colon Cancer, CRC liver metastasis, patient-derived model