OncoMatch/Clinical Trials/NCT04109755
Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer
Is NCT04109755 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT04109755 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage T3-T4 N0 OR T ANY OR N1-2, M0 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages