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

StatusRecruiting
PhasePhase 2
Started2024-06-13
View on ClinicalTrials.gov ↗

Amendment history

2026-05-05
critical
Study Status v7
Primary completion pushed: 2028-05 → 2030-05
Completion pushed: 2028-05 → 2030-05
2026-03-13
minor
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v6
Enrollment target33→44
Study arms3→4
Eligibility criteria+132 characters
[...] n informed consent document. Inclusion Criteria for Cohort C and D: Age ≥18 years. Eastern Cooperative Oncology Group (ECOG) p [...] emed a poor surgical candidate after evaluation by a surgeon or unwilling to undergo surgery. Must not have received any prior systemic treatment or rad [...] low the study schedule for any reason Exclusion for Cohort C and D: Have received an investigational agent or used an investig [...] ng corneal allograft. Patient is pregnant or breastfeeding. Cohort D Only: Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline. Conditions, including alcohol or drug dependence [...]
2025-12-01
minor
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2025-05-27
minor
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v4
Enrollment target22→33
Study arms2→3
Eligibility criteria+2,120 characters
Inclusion Criteria for Cohort A and B: Age ≥70 years. Eastern Cooperative Oncology Group (ECOG) p [...] defined by study-specified laboratory tests and procedures. LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration. For both Women and Men, must use acceptable form of birth co [...] nd willingness to sign a written informed consent document. Inclusion Criteria for Cohort C: Age ≥18 years. Eastern Cooperative Oncology Group (ECOG) performance status 0 -3. Have histologically proven localized or locally advanced mismatch repair [...] [...]
2024-06-24
minor
Study Status v3
Start dateestimated 2024-06→confirmed 2024-06-13
Show 2 earlier versions
2024-05-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2024-05-02
minor
Study Status v1
Start date2024-05→2024-06
2024-01-04
minor
Original filing
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.
Trial Details
NCT Number NCT06205836
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Regeneron Pharmaceuticals
Conditions Colorectal Cancer
Enrollment 44 participants
Start Date 2024-06-13
Primary Completion 2030-05 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-06