NCT03794128

A Study of Personalized Neoantigen Cancer Vaccines

An Observational Feasibility Study for the Production of a Patient-Specific Neoantigen Cancer Vaccine and Screening Study for a Shared Neoantigen Cancer Vaccine in Patients With Advanced Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Gritstone bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is 1) to evaluate the feasibility of manufacturing a patient-specific neoantigen cancer vaccine, which involves predicting the patient's neoantigens and generating a vaccine that encodes the predicted neoantigens; and, 2) to identify and select patients who may be eligible for a shared neoantigen cancer vaccine where their tumor contains a specific shared mutation and who have the correct HLA allele capable of presenting the neoantigen derived from the tumor-specific mutation.

Detailed description

Gritstone is developing two neoantigen-based cancer vaccines: the first is a patient-specific cancer vaccine that requires a manufacturing period for each patient and the second is an off-the-shelf cancer vaccine that targets shared neoantigens. The process of generating a patient-specific neoantigen cancer vaccine involves multiple steps, including collection of patient tumor and blood specimens, performing next-generation sequencing (NGS), predicting the neoantigens to be included in the patient-specific vaccine, and the manufacture and release of the patient-specific vaccine. Gaining experience in managing the manufacturing process will provide important insights and experience regarding this process to be used in operationalizing future clinical trials. Selecting patients who may be eligible to receive a shared neoantigen vaccine requires first identifying patients whose tumor possesses a neoantigen derived from an oncogenic mutation that is encoded by the vaccine, and then determining whether the patient expresses a matching HLA allele for antigen presentation. Study participants will not receive any investigational treatment as part of this trial. Patients screened in this study may be able to enroll in a separate investigational treatment study sponsored by Gritstone Oncology, provided that the patient meets the specified eligibility criteria for that treatment study.

Conditions

• Non Small Cell Lung Cancer
• Colorectal Cancer
• Gastroesophageal Adenocarcinoma
• Urothelial Carcinoma
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Blood collection for research (next-generation sequencing [NGS])	Participants will have whole blood collected for next-generation sequencing (NGS).
PROCEDURE	Blood collection for research (HLA typing)	Participants will have whole blood collected for HLA typing.

Timeline

• Start date: 2018-07-25
• Primary completion: 2020-01-17
• Completion: 2020-05-26
• First posted: 2019-01-04
• Last updated: 2020-09-11

Locations

5 sites across 1 country: United States