Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer

Phase 2 Completed 30 enrolled Blokhin's Russian Cancer Research Center

NaSingle-groupOpen-labelTreatment

Summary

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)

Timeline

Start: 2022-03-31
Primary completion: 2024-12-31
Completion: 2025-06-30

Outcome

Met primary endpoint

paper The study met its primary end point, with 17 (56.7%) of 30 patients achieving pCR (n = 16) + cCR (n = 1 as nonoperated case). PMID 41370727 ↗

Publications

Kuznetsova O, Zagidullina A, Drobot N, Prokopiev A, Ivanov M, Fedyanin M, Mamedli Z, Aliev V, Polynovsky A, Dzhumabaev K, Aniskin A, Stroganova A, Karasev I, Tryakin A. Neoadjuvant Immunotherapy With Prolgolimab in Patients With Locally Advanced Microsatellite Instability/Defective Mismatch Repair Colorectal Cancer. JCO Precis Oncol. 2025 Dec;9:e2500602. doi: 10.1200/PO-25-00602. Epub 2025 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prolgolimab	Monoclonal antibody	1 mg/kg	Intravenous