OncoMatch/Clinical Trials/NCT06428487
Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer
Is NCT06428487 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Prolgolimab for colorectal cancer.
Treatment: Prolgolimab — In this phase II study patients with stage II-III MSI/dMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy (prolgolimab). The duration of treatment is 6 months (12 cycles)
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage CT3-4N0-2M0 (COLON/SIGMOID), CT3 WITH DEPTH ≥5MM (RECTAL), CT2N0 AND HIGHER (LOWER AMPULLARY RECTAL), T4 (RECTAL), LATERAL RESECTION MARGIN INVOLVEMENT (RECTAL) (CT/MRI)
Excluded: Stage DISTANT METASTASES
Locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: monoclonal antibody immunotherapy (anti-PD1, anti-PD-L1, anti-PD-L2, anti-CTLA4)
Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
Cannot have received: systemic immunosuppressive drugs (prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF antagonists)
Exception: systemic glucocorticosteroids (GCS) in replacement doses (≤10 mg prednisolone/day), short-term use (≤7 days), inhaled/topical GCS allowed
Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF [tumor necrosis factor] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy during the first year of the study. The use of systemic glucocorticosteroids (GCS) in replacement doses (for example, in a dose equivalent to 10 mg of prednisolone per day or less), short-term use of systemic GCS (≤7 days), inhaled and topical GCS are allowed.
Cannot have received: radiation therapy
Exception: cases of metachronous tumors over 5 years ago
Previously performed radiation or chemotherapy for colorectal cancer, with the exception of cases of metachronous tumors over 5 years ago
Cannot have received: chemotherapy
Exception: cases of metachronous tumors over 5 years ago
Previously performed radiation or chemotherapy for colorectal cancer, with the exception of cases of metachronous tumors over 5 years ago
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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