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Pembrolizumab + mFOLFOX6 in Advanced Colorectal Cancer
NCT02375672Phase 2
Key facts
- Status
- Completed
- Start
- May 2015
- Primary completion
- Oct 2020
- Countries
- 1
- Sponsor
- Hoosier Cancer Research Network
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of pembrolizumab in colorectal cancer (CRC), sponsored by Hoosier Cancer Research Network. Primary endpoint: Median Progression Free Survival at 14 months. Started May 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Pembrolizumab + mFOLFOX6
Pembrolizumab 200mg IV q3w + mFOLFOX6 (Oxaliplatin, Leucovorin, 5FU) q2w
03
Who it enrols
Adult patients with advanced colorectal adenocarcinoma, ECOG 0-1, no prior systemic therapy for metastatic disease, and adequate organ function. Excludes patients with active autoimmune disease, HIV, Hepatitis C, or prior checkpoint inhibitor therapy.
04
Endpoints
Primary
Median Progression Free Survival
Secondary
Objective Response Rate
Disease Control Rate
Overall Survival
Number of Patients With Grade 3 or Higher Treatment Related Adverse Event
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