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

Phase 2

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Cemiplimab; Drug: Fianlimab

• Registration Number: NCT06205836
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Study Start: 2024-06-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A - Cemiplimab	Cemiplimab	-
Cohort B - Cemiplimab with Fianlimab	Cemiplimab	-
Cohort B - Cemiplimab with Fianlimab	Fianlimab	-
Cohort C - Cemiplimab	Cemiplimab	-

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	6 Months	Proportion of subjects with either a pathologic complete response (pCR) at the time of surgery OR a clinical complete response (cCR) at 6 months for those subjects who do not undergo surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen. cCR is defined as an absence of visible disease on CT imaging by RECIST 1.1 and endoscopic evaluation.

Secondary Outcome Measures

Name	Time	Method
Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation	7 Months	Defined using NCI CTCAE v5.0

Trial Locations

Locations (1)

Johns Hopkins SKCCC; 🇺🇸 Baltimore, Maryland, United States