Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
ConditionColon Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Strickler, M.D.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically and/or cytologically documented adenocarcinoma of the colon
Tumor testing indicating proficient mismatch repair and/or microsatellite stable (pMMR/MSS)
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)
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
DrugImmune checkpoint inhibition with antibodies directed against PD-1 and CTLA-4 receptors have demonstrated significant and durable efficacy in several advanced malignancies. LAG-3 is classified as an immune checkpoint protein that negatively regulates T cell activity, similar to PD-1 and CTLA-4. Blockade of LAG-3 with antibodies such as fianlimab, especially in combination with anti-PD-1 therapy, may represent a potentially effective or enhanced treatment for advanced malignancies. We hypothesize that cemiplimab in combination with fianlimab is feasible, safe, and effective neoadjuvant treatment strategy for early-stage colon cancer.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Cemiplimab in combination with FianlimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of treatment with cemiplimab and fianlimab before surgery
Measured by the proportion of patients completing surgery within 60 days after Day 1 of treatment with cemiplimab and fianlimab
Time frame
60 days after first study treatment2
Safety of treatment with cemiplimab and fianlimab before surgery
The frequency and severity of adverse events, according to NCI CTCAE V6.0
Time frame
AEs will be assessed from Day 1 through Day 112 (90 days after the last dose of study treatment)Secondary outcomes
1
Two-year disease-free survival
Measured from surgery until documented disease recurrence among patients with R0 resection and no known metastatic disease following resection of the primary tumor
Time frame
Up to two years after surgery2
Pathological Response
Measurement of residual viable tumor at the time of resection
Time frame
Resection is to occur from 30 to 60 days after the first dose of study drugLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
John Strickler, M.D.
Lead sponsor
Duke University
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: