Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

NCT ID: NCT06205836

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2028-05-31

Brief Summary

The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A - Cemiplimab

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Cohort B - Cemiplimab with Fianlimab

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Fianlimab

Intervention Type: DRUG

Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Cohort C - Cemiplimab

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Interventions

Cemiplimab

Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Intervention Type: DRUG

Fianlimab

Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Intervention Type: DRUG

Other Intervention Names

REGN2810, LIBTAYO; REGN3767

Eligibility Criteria

Inclusion Criteria

• Age ≥70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
• Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
• Must not have received any prior systemic treatment or radiation.
• Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
• Patient's acceptance to have a tumor biopsy.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
• LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
• For both Women and Men, must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 -3.
• Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
• Patient deemed a poor surgical candidate after evaluation by a surgeon.
• Must not have received any prior systemic treatment or radiation.
• Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
• Patient's acceptance to have a tumor biopsy.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
• For both Women and Men, must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

• Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
• Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
• Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
• History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.
• Currently using any chronic systemic steroids.
• Patient has received a live vaccine within 30 days of the first dose of study drug.
• History of severe hypersensitivity reaction to any monoclonal antibody.
• Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
• Active autoimmune disease.
• Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
• Patient has a pulse oximetry of <92% on room air.
• Patient is on supplemental home oxygen.
• Has clinically significant heart disease.
• Cohort B Only: Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
• Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
• Unwilling or unable to follow the study schedule for any reason

Exclusion for Cohort C:

• Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
• Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
• Currently using any chronic systemic steroids.
• Patient has received a live vaccine within 30 days of the first dose of study drug.
• History of severe hypersensitivity reaction to any monoclonal antibody.
• Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
• Patient is pregnant or breastfeeding.
• Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
• Participation deemed not in the best interest of the patient.
• Unwilling or unable to follow the study schedule for any reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Christenson, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

Locations

Johns Hopkins SKCCC

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colleen Apostal, RN

Role: CONTACT

GIClinicalTrials@jhmi.edu

410-614-3644

Facility Contacts

Colleen Apostol, RN

Role: primary

GIClinicalTrials@jhmi.edu

410-614-3644

Other Identifiers

IRB00415816

Identifier Type: OTHER

Identifier Source: secondary_id

J23155

Identifier Type: -

Identifier Source: org_study_id