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

NCT06205836 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-06

No results posted yet for this study

Summary

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 or unwilling to undergo surgery.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2030-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205836 on ClinicalTrials.gov