OncoMatch/Clinical Trials/NCT04109755
Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer
Is NCT04109755 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for rectum cancer.
Treatment: Pembrolizumab — This project investigates the clinical and biological impact of combining immunotherapy (pembrolizumab) with short course radiotherapy (5Gy, five times) in the neo-adjuvant treatment of localised microsatellite stable (MSS) rectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3-T4 N0 OR T ANY OR N1-2, M0
Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received for the same disease prior systemic anti-cancer therapy including investigational agents prior to starting pembrolizumab.
Cannot have received: radiotherapy
Exception: If treated with radiotherapy for another disease, participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has received prior radiotherapy for the same disease.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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