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

StatusRecruiting
PhasePhase 2
Started2026-07-14
View on ClinicalTrials.gov ↗

Amendment history

2026-07-20
Study Status v6
Start dateestimated 2026-07→confirmed 2026-07-14
2026-06-30
Study Status, Contacts/Locations v5
Recruitment opened
Study sitescontacts updated at 1 of 1 site
2026-06-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2026-05-05
Study Status v3
Primary completion pushed: 2030-05 → 2030-07
Completion pushed: 2030-05 → 2030-07
Start date2026-05→2026-07
2026-04-27
Study Status v2
Primary completion pushed: 2030-04 → 2030-05
Completion pushed: 2030-04 → 2030-05
Start date2026-04→2026-05
2026-03-17
Study Status v1
Primary completion date2030-03→2030-04
Completion date2030-03→2030-04
Start date2026-03→2026-04
2025-12-04
Original filing
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).
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