At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 25 target
Drug / intervention
Pembrolizumabdrug
Likely dose
Pembrolizumab 200 mgfrom record
Key inclusion· 8
- ✓Age at least 18 years
- ✓Histologically confirmed rectal adenocarcinoma
- ✓ECOG performance status 0-1
- ✓Previously untreated localized T3-T4 N0 or T any N1-2, M0 disease
Key exclusion· 17
- ✕Microsatellite instable (MSI-High) tumour
- ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, CTLA-4, OX40, or CD137 therapy
- ✕Prior systemic anti-cancer therapy for the same disease
- ✕Prior radiotherapy for the same disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04109755Phase 2RecruitingUpdate OverdueUpdated 57mo ago · Completion was 49mo agoEnrollment Stalled
Long Recruiting
Update Overdue
A Phase II Study to Evaluate Safety and Efficacy of Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab for Rectum Cancer and Rectal Cancer. Currently recruiting, targeting 25 participants across 1 site.
Signals
Enrollment appears stalled
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectum Cancer, Rectal Cancer
CountriesSwitzerland
Collaborators--
Timeline
Phase 2Recruiting
202020212022202320242025202620272028
First PostedSep 2019
Enrollment StartJun 2020
Primary CompletionJun 2022
TodayJul 2026
Study CompletionMar 2028
First PostedSep 30, 2019
Enrollment StartJun 2, 2020
Primary CompletionJun 1, 2022
Study CompletionMar 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.8 years ago
Interventions
Pembrolizumabdrug
5x5 Gy radiotherapy in 1 week, 4 cycles of Pembrolizumab (200 mg every three week), surgery