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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically and/or cytologically documented adenocarcinoma of the colon
. No evidence of measurable distant metastatic disease (as per RECIST v1.1 criteria) based on CT of the chest, abdomen, and pelvis
. T4N0 or stage III colon cancer as per baseline CT imaging (see Appendix E for imaging guidelines)
. Candidate for surgical resection with curative intent
. Age ≥ 18 years
. ECOG Performance Score of 0 or 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of treatment with cemiplimab and fianlimab before surgery
Timeframe: 60 days after first study treatment
2
Safety of treatment with cemiplimab and fianlimab before surgery
Timeframe: AEs will be assessed from Day 1 through Day 112 (90 days after the last dose of study treatment)
. Any previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1, or LAG3.
. Any previous surgery, chemotherapy, radiotherapy or targeted therapy for colon or rectal cancer.
. 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.