At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Single Arm, Phase II Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer: HCRN GI14-186
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab and mFOLFOX6 for Colorectal Cancer. Completed, enrolled 30 participants across 3 sites.
Detailed Summary
This is a multi-institutional, single arm, open-label, phase II study, including a safety run-in cohort. No randomization or blinding involved.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMay 2015
Primary CompletionOct 2020
TodayJul 2026
First PostedMar 2, 2015
Enrollment StartMay 28, 2015
Primary CompletionOct 8, 2020
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 11.3 years ago
Interventions
Pembrolizumabdrug
Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
mFOLFOX6drug
mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days) * Oxaliplatin 85 mg/m\^2 IV with * Leucovorin 400 mg/m\^2 IV followed by * 5FU 400 mg/m\^2 bolus and then 2400 mg/m\^2 via continuous infusion