A Phase 2, Open Label, Randomized Study of Neoadjuvant Dostarlimab Plus CAPEOX Versus CAPEOX in Participants With Previously Untreated T4N0 or Stage III MMRp/ MSS Colon Cancer
The main goal of this study is to test a new treatment approach for colon cancer. The treatment involves dostarlimab along with a specific type of chemotherapy called CAPEOX (short for capecitabine + oxaliplatin) to check if using these two together works better than using just CAPEOX by itself. This treatment is given before any surgery takes place; a method referred to as neoadjuvant therapy. . The aim is to see if this new approach can show early signs of effectiveness in treating participants with a specific type of colon cancer known as mismatch repair proficient/ microsatellite stable (MMRp/MSS), where the cells have normal repair systems and stable DNA sequences. This study will also look at specific signs in the blood and tumor to see if they can help predict how well the treatment is working. This could help better understand how dostarlimab contributes to the response of the disease to treatment.
• Has untreated pathologically confirmed colon adenocarcinoma
• Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
• Has a tumor demonstrating the presence of either-
‣ MMR status: MMR status must be assessed by Immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp; MMR status may be determined local laboratory; or
⁃ MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS), determined by local laboratory
• Provides fresh tumor tissue obtained during either the pre-screening or screening period via colonoscopy performed per procedure manual. Tissue biopsy is required
• Is willing to use adequate contraception male and/or female participants
• Has an Eastern Cooperative Oncology Group - Performance status (ECOG-PS) of 0 or 1
• Has adequate organ function