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

Description

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.

Conditions

Colorectal Cancer

Study Overview

Study Details

Study overview

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.

Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins SKCCC, Baltimore, Maryland, United States, 21231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.
  • * 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 is on supplemental home oxygen.
  • * Has clinically significant heart disease.
  • * 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

Ages Eligible for Study

70 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Eric Christenson, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

Study Record Dates

2028-05