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Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer

NCT02375672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-16

Study results available
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Summary

This is a multi-institutional, single arm, open-label, phase II study, including a safety run-in cohort. No randomization or blinding involved.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks

DRUG

mFOLFOX6

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

Sponsors & Collaborators

Principal Investigators

  • Safi Shahda, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-28
Primary Completion
2020-10-08
Completion
2020-10-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375672 on ClinicalTrials.gov