Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

for Cohort A and B: - 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. Inclusion Criteria for Cohort C: - 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

for Cohorts A and B: - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A - Cemiplimab
  • Drug: 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.
    Other names:
    • REGN2810, LIBTAYO
Experimental
Cohort B - Cemiplimab with Fianlimab
  • Drug: 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.
    Other names:
    • REGN2810, LIBTAYO
  • 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.
    Other names:
    • REGN3767
Experimental
Cohort C - Cemiplimab
  • Drug: 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.
    Other names:
    • REGN2810, LIBTAYO

Recruiting Locations

Johns Hopkins SKCCC
Baltimore 4347778, Maryland 4361885 21231
Contact:
Colleen Apostol, RN
410-614-3644
GIClinicalTrials@jhmi.edu

More Details

Status
Recruiting
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Contact

Colleen Apostal, RN
410-614-3644
GIClinicalTrials@jhmi.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.