A Study of a Personalized Neoantigen Cancer Vaccine

Colorectal Cancer Clinical Trial

Official title: An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Transitional Cell
• Colorectal Cancer
• Gastroesophageal Adenocarcinoma
• Non Small Cell Lung Cancer
• Urothelial Carcinoma

• NCT number: NCT03639714
• Study type: Interventional
• Source: Gritstone bio, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 13, 2019
• Completion date: November 10, 2022