J23155: Evaluating a Surgical-Sparing Approach Using Cemiplimab with or without Fianlimab to Treat Older Patients with Localized or Locally Advanced MSI-H Colorectal Cancer
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
II
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Brief Summary
This is a phase 2 study to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable (MSI-H) localized or locally advanced colorectal cancer patients age 70 or greater.The trial will enroll two cohorts of MSI-H stage I, II, or III colorectal cancer patients who will receive either cemiplimab every 3 weeks or cemiplimab in combination with fianlimab every 3 weeks for a total of 4 doses (12 weeks total). Each cohort will enroll up to 11 evaluable patients. The two cohorts will enroll sequentially. The first 11 evaluable patients will receive cemiplimab monotherapy while the second 11 will receive cemiplimab in combination with fianlimab.
Eligibility
Age 70 years or older; Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.