MedTrace Logo

Pembrolizumab + Poly-ICLC in MRP Colon Cancer

NCT02834052 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-06-07

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to determine the dose of poly-ICLC that is safe and tolerable when it is combined with pembrolizumab in patients with colon cancer. This study will also evaluate how the combination of pembrolizumab and poly-ICLC activates the immune system in the patient's blood and inside the tumor; how it affects the size and number of tumor(s) in each patient; and how effective the combination is in patients with colon cancer that is unlikely to respond to pembrolizumab alone.

Conditions

Interventions

DRUG

pembrolizumab

200mg pembrolizumab will be given intravenously on Day 1 of each 3-week cycle

DRUG

Poly-ICLC

The maximum tolerated dose of Poly ICLC will be given twice weekly, in each 3-week cycle: Week 1, Days 1 and 4 Week 2, Days 8 and 11 Week 3, Days 15 and 18

Sponsors & Collaborators

Principal Investigators

  • Asha Nayak, MD · Georgia Cancer Center at Augusta University

  • Sharad Ghamande, MD · Georgia Cancer Center at Augusta University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2022-07-29
Completion
2022-07-29
FDA Drug
Yes

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 NCT02834052 on ClinicalTrials.gov