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

ClinicalTrials.gov ID: NCT02260440

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT02260440
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Anuradha Krishnamurthy; Other
Enrollment: 31 participants

Conditions and interventions

Conditions

Metastatic Colorectal Cancer

Interventions

Pembrolizumab Drug
Azacitidine Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2015 (Type not available)
Primary completion: Mar 2016 (Actual)
Completion: Sep 2017 (Actual)
Last update posted: Sep 17, 2019

2015 – 2017

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02260440, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 17, 2019 · Synced Nov 15, 2026