drugset / Trial / NCT07281768
Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
Phase 2
Recruiting
66 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Regeneron Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2026-07
- Primary completion
- 2030-07
- Completion
- 2030-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Cemiplimab | Monoclonal antibody | 350 mg | Intravenous |
| Subject | DALMITAMIG | Monoclonal antibody | 2700 mg | Intravenous |
| Subject | Fianlimab | Monoclonal antibody | 1600 mg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |