Last updated on February 2020

A Study of a Personalized Neoantigen Cancer Vaccine

Brief description of study

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

Detailed Study Description

Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations can present peptides containing these mutations as non-self antigens in the context of HLA on the tumor cell surface. A fraction of mutated peptides result in neoantigens capable of generating T-cell responses that exclusively target tumor cells. Sensitive detection of these mutations allows for the identification of neoantigens unique to each patient's tumor to be included in a personalized cancer vaccine that targets these neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost approach (GRT-C901 first followed by GRT-R902) to stimulate an immune response. This study will explore the safety and early clinical activity of this patient-specific immunotherapy intended to induce T-cell responses specific for neoantigens.

Clinical Study Identifier: NCT03639714

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Tennessee Oncology

Nashville, TN United States
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The University of Chicago

Chicago, IL United States
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Virginia Cancer Specialists

Fairfax, VA United States
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Mayo Clinic Arizona

Phoenix, AZ United States
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Mayo Clinic

Jacksonville, FL United States
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Mayo Clinic

Rochester, MN United States
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MD Anderson Cancer Center

Houston, TX United States
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Recruitment Status: Open

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