NCT03639714

A Study of a Personalized Neoantigen Cancer Vaccine

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Gritstone bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	GRT-C901	a patient-specific neoantigen cancer vaccine prime
BIOLOGICAL	GRT-R902	a patient-specific neoantigen cancer vaccine boost
BIOLOGICAL	nivolumab	anti-PD-1 monoclonal antibody
BIOLOGICAL	ipilimumab	anti-CTLA-4 monoclonal antibody

Timeline

• Start date: 2019-02-13
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2018-08-21
• Last updated: 2023-09-13

Locations

11 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study