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A Phase 2 Study of Pembrolizumab (MK-3475) in Combination With Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer

NCT02260440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-09-17

Study results available
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Summary

This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety, and tolerability of Pembrolizumab in combination with azacitidine in subjects with chemo-refractory mCRC without any further standard treatment options

Dosage and regimen for all study periods

* Pembrolizumab will be given at 200 mg every 21 days.
* Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.

The first assessment of tumor response will be performed after cycle 3 (9 weeks), and thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1 will be used to establish disease response or progression.

All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events, version 4.0 (NCI-CTCAE).

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be given at 200 mg every 21 days

DRUG

Azacitidine

Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.

Sponsors & Collaborators

Principal Investigators

  • Anuradha Krishnamurthy, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-03-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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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 NCT02260440 on ClinicalTrials.gov