A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic Colorectal Cancer

UVA Tracking #
Principal Investigator
Matthew J Reilley
Contact Phone
Official Trial Title
A phase 2/3, randomized, open-label study of maintenance GRT-C901/GRT-R902, a neoantigen vaccine, in combination with immune checkpoint blockade for patients with metastatic colorectal cancer
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have
microsatellite stable (MSS) Metastatic Colorectal Cancer and are starting, or have recently started, first-line
therapy. The purpose of this clinical research study is to learn more about an experimental therapeutic vaccine
that is “patient-specific”, meaning the vaccine each patient receives is developed specifically for them based on
their tumor makeup. We will learn more about the effects of this vaccine on your cancer when used together with standard therapy approved for other types of cancer that activate the immune system [ipilimumab (Yervoy®) and atezolizumab (Tecentriq ®), in combination with a fluoropyrimidine and bevacizumab
(Avastin®); all of your standard of care treatments have been approved by the United States Food and Drug
Administration (FDA) including several fluoropyrimidines (capecitabine (Xeloda®), FUDR (Floxuridine®),
and 5-fluorouracil [several brands available])].

Your participation in this study is divided into two parts, Vaccine Production Stage and Study Treatment Stage.
After you have completed up to 6 months of standard therapy, if you were randomized to the vaccine arm
during the Vaccine Production Stage, you will receive the vaccine that was made for you in addition to your
standard therapy. If you were randomized to the control arm during the Vaccine Production Stage, you will
continue to receive your standard therapy. There is a 50% chance you will be randomized to the vaccine arm or
control arm.

Your participation in this study will last until your disease gets worse or for approximately two years, unless you decide to stop the study.

Study-related procedures that are being done as part of the study and beyond your standard of care will be
provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05141721


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