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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06205836

Patient View

This study assesses the safety and efficacy of cemiplimab alone or with fianlimab in patients aged 70+ with MSI-H colorectal cancer. Eligible participants must have dMMR/MSI-H cancer, ECOG status 0-2, and no prior systemic treatment. Interventions include cemiplimab (350 mg) and fianlimab (1600 mg) IV every 21 days for 4 cycles. Participants must consent to biopsies and 24-month surveillance.

Patient Parameters

Program 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.

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.
  • 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.
  • 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

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