OncoMatch/Clinical Trials/NCT06567782
A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer
Is NCT06567782 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dostarlimab and CAPEOX for neoplasms, colon.
Treatment: Dostarlimab · CAPEOX — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: MLH1 proficient expression (present)
MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp
Required: MSH2 proficient expression (present)
MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp
Required: MSH6 proficient expression (present)
MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp
Required: PMS2 proficient expression (present)
MMR protein expression (MLH1, MSH2, MSH6, PMS2) where all proteins are present indicates MMRp
Required: MSI microsatellite stable
MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS)
Required: MSI microsatellite instability-low
MSS or Microsatellite Instability-L (MSI-L) phenotype as determined by polymerase chain reaction (PCR) or by tissue next generation sequencing (NGS)
Disease stage
Required: Stage T4N0, STAGE III
Excluded: Stage DISTANT METASTATIC DISEASE
resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Cannot have received: immunotherapy
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Cannot have received: biologic
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Cannot have received: targeted therapy
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Cannot have received: radiation therapy
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Cannot have received: surgery
Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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