MedTrace Logo

A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens

NCT03953235 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-09-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the dose, safety, immunogenicity and early clinical activity of GRT-C903 and GRT-R904, a neoantigen-based therapeutic cancer vaccine, in combination with immune checkpoint blockade, in patients with advanced or metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, pancreatic cancer, and shared neoantigen-positive tumors. Based on the Phase 1 data, an updated vaccine candidate (SLATE-KRAS or version 2) was developed that removed 16 of the 20 mutations included in the original vaccine (version 1) and solely targets KRAS mutations.

Conditions

Interventions

BIOLOGICAL

GRT-C903

a shared neoantigen cancer vaccine prime

BIOLOGICAL

GRT-R904

a shared neoantigen cancer vaccine boost

BIOLOGICAL

nivolumab

anti-PD-1 monoclonal antibody

BIOLOGICAL

ipilimumab

anti-CTLA-4 monoclonal antibody

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2023-03-10
Completion
2023-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953235 on ClinicalTrials.gov