Clinical Trial

Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer

Recruiting Phase 2
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Summary
The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).
Protocol Amendment History 5 changes
critical Recruitment opened 2026-07-01
notable Primary completion pushed: 2030-05 -> 2030-07 2026-05-07
minor Completion pushed: 2030-05 -> 2030-07 2026-05-07
notable Primary completion pushed: 2030-04 -> 2030-05 2026-04-30
minor Completion pushed: 2030-04 -> 2030-05 2026-04-30
Trial Details
NCT Number NCT07281768
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Regeneron Pharmaceuticals
Conditions Colorectal Cancer
Enrollment 66 participants
Start Date 2026-07-14
Primary Completion 2030-07 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-21