A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer

Phase 2 Completed 35 enrolled University of Birmingham Bristol-Myers Squibb · collab

NaSingle-groupOpen-labelTreatment

Summary

An open-label, single-arm, phase II, multicentre clinical trial to determine the rate of durable clinical benefit of nivolumab in patients with class II expressing microsatellite stable colorectal cancer.

Timeline

Start: 2019-08-28
Primary completion: 2024-11-26
Completion: 2024-11-26

Outcome

Missed primary endpoint

paper 0.002 probability that the true DCBR was >30%, below the required 0.5 to warrant further research. PMID 41407398 ↗

paper tsMHC-II positivity fails to identify a subset of patients with metastatic pMMR CRC obtaining potentially meaningful benefit from single-agent anti-PD-1. PMID 41407398 ↗

Publications

Results Middleton G, Gaskell C, Savage J, Bridgewater J, Ross P, Saunders M, Palmer D, Plummer R, Clive S, Coyle V, Thomas A, Cunningham D, Taniere P, Billingham L. Final results of ANICCA-Class II, a single arm, open-label phase II trial assessing nivolumab in tissue-specific class II expressing metastatic microsatellite stable colorectal cancer, with a parallel assessment of the immunoscore-immune checkpoint as a predictive biomarker for single-agent anti-PD-1. J Immunother Cancer. 2025 Dec 17;13(12):e012749. doi: 10.1136/jitc-2025-012749.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous