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

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 ID
NCT07281768
Phase
PHASE2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Oxaliplatin
  • Capecitabine
  • Cemiplimab
  • Fianlimab
  • REGN7075
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
  • Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.
  • Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.

For full eligibility, visit ClinicalTrials.gov.

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