Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hep… (NCT03844750) | Clinical Trial Compass
TerminatedPhase 2
Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases
Stopped: Sponsor decision
United States6 participantsStarted 2019-07-22
Plain-language summary
This phase II trials studies how well pembrolizumab and vactosertib work after standard of care chemotherapy in patients with colorectal cancer that has spread to the liver that can be removed by surgery (resectable hepatic metastases). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vactosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and vactosertib after standard of care chemotherapy, but before liver metastases surgery, may help shrink the cancer prior to surgery. This study also investigates pembrolizumab and vactosertib after liver metastases surgery, decrease the risk of the cancer recurring (coming back).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has histologically or cytologically confirmed CRC with liver metastases. In addition to liver metastases, extrahepatic metastases (e.g. pulmonary metastases) may be permitted if all other eligibility criteria are met. Participants are permitted to have primary tumor in situ (Neoadjuvant Arm only).
✓. Has received previous oxaliplatin-based chemotherapy.
✓. Is an appropriate candidate to undergo liver biopsy and resection (+/-ablation) of liver metastases (Neoadjuvant Arm Only).
✓. Is willing and able to provide written informed consent/assent for the trial. The participants may also provide consent for Future Biomedical Research. However, may participate in the main trial without participating in Future Biomedical Research.
✓. Is \>=18 years of age on day of signing informed consent.
✓. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions (Neoadjuvant Arm Only).
✓. Is willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained after last dose of standard of care lead-in chemotherapy \[if applicable\] and within 28 days prior to first dose of pembrolizumab (Neoadjuvant Arm Only).
What they're measuring
1
Proportion of Patients With a >= 2-fold Increase in the Tumor-infiltrating Cells Per Unit Area (5 High Power Fields) in Post- Versus Pre Pembrolizumab Treatment Tumor Specimens.
✓. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Exclusion criteria
✕. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
✕. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
✕. Has active hepatitis B (defined as hepatitis B surface antigen (HBsAg) reactive) or active hepatitis C virus (HCV) (defined as HCV RNA \[qualitative\] is detected) infection.
✕. Has received prior anti-cancer monoclonal antibody (mAb), systemic anticancer therapy other than FOLFOX (including investigational agents), targeted small molecule therapy, or radiation therapy within 14 days prior to the first dose of study treatment (day 1).
✕. Has received FOLFOX less than 7 days prior to the first dose of study treatment (day 1). Has not recovered (i.e., =\< grade 1 or at baseline) from AEs due to FOLFOX chemotherapy.
✕. Has not recovered adequately from toxicity or complications of a surgery or other procedure, per the assessment of the treating investigator.