Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer (NCT07224022) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
24 participantsStarted 2026-07-01
Plain-language summary
This is a research study to test whether two immunotherapy drugs-cemiplimab and fianlimab-can safely and effectively shrink colon tumors before surgery in people with stage II-III colon cancer that has not spread to other parts of the body.
Participants will receive two doses of the study drugs through an IV (one on Day 1 and one on Day 22). During the study, participants will have regular visits to the study clinic and multiple tests for safety and research purposes, including blood tests, along with other tests and scans, followed by surgery to remove the tumor. The study will follow participants' health for up to three years after surgery.
Risks of cemiplimab and fianlimab include fatigue, diarrhea, skin rash, thyroid problems, and immune-related side effects such as inflammation of the lungs, liver, or intestines.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically and/or cytologically documented adenocarcinoma of the colon
✕. Clinical or radiographic evidence of bowel obstruction or perforation.
✕. In the opinion of the Principal Investigator, any medical condition (e.g., significant gastrointestinal bleeding, symptomatic disease) that would preclude participation in study activities (e.g., colonoscopy, immunotherapy, surgery).
✕. Uncontrolled pain related to primary colon malignancy.
✕. Radiotherapy to the primary tumor prior to or planned post-surgery.
✕. Gastrointestinal bleeding requiring a blood transfusion within 30 days of screening.
✕. Treatment with another investigational device or study drug or participation in another drug study within 30 days of screening. Other investigational procedures while participating in this study are excluded.