Trial Summary
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.
Lead Sponsor: GlaxoSmithKline
Participants: ALL
Start Date: 2025-02-17
Primary Completion: 2026-11-23
Min Age: 18 Years
Eligibility Criteria
Inclusion Criteria: * 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- 1. 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 2. 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 Exclusion Criteria: * Has distant metastatic disease * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer * Has, in the investigator's opinion, a tumor that is not amenable to surgery or has any other contraindication to surgery * Has experienced any of the following with…
Data sourced from ClinicalTrials.gov. Trial details may change — always check the primary source before clinical decisions.