RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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 or in patients age 18 or greater considered poor candidates for surgery.

Official Title

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

Quick Facts

Study Start:2024-06-13
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06205836

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

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

Study Locations (Sites)

Johns Hopkins SKCCC
Baltimore, Maryland, 21231
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-13
Study Completion Date2028-05

Study Record Updates

Study Start Date2024-06-13
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • Colorectal Cancer
  • Cemiplimab
  • Fianlimab
  • Immunotherapy
  • Anti-PD-1 therapy
  • Anti-Lag-3
  • Adenocarcinoma
  • Carcinoma

Additional Relevant MeSH Terms

  • Colorectal Cancer