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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06205836
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Patients will receive cemiplimab (350 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.
  • Fianlimab — DRUG
    Patients will receive fianlimab (1600 mg administered IV) on Day 1 of each 21 day cycle for a total of 4 cycles of treatment.

Study Details

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.

Key Dates

Start date
Jun 13, 2024
Status verified
May 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - Cemiplimab
  • Experimental: Cohort B - Cemiplimab with Fianlimab
  • Experimental: Cohort C - Cemiplimab
  • Experimental: Cohort D - Cemiplimab with Fianlimab

Primary Outcome Measure

Complete Response Rate [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins SKCCCBaltimoreMaryland21231
Colleen Apostol, RN
[email protected]
410-614-3644
Eric Christenson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Johns Hopkins SKCCC· Baltimore, MD

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