A Screening Study Targeting Tumor-specific Antigens

October 17, 2022 updated by: Gritstone bio, Inc.

A Screening Study for the Selection of Patients for Clinical Studies Targeting Tumor-specific Antigens

The purpose of this study is to identify patients who may be eligible to participate in a separate Phase 2/3 treatment study evaluating an individualized neoantigen vaccine GRANITE for first line (1L) maintenance treatment of metastatic, microsatellite-sable colorectal cancer (MSS-CRC) sponsored by Gritstone bio. This may include the manufacturing of an individualized vaccine, which involves neoantigen prediction and generating a vaccine targeting neoantigens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The screening study can enroll multiple tumor types in multiple treatment settings for the potential inclusion in a treatment study. Patient's tumors are analyzed to determine if the patient's tumor contains sufficient mutations. This screening study is currently enrolling patients with localized colon cancer or metastatic colorectal cancer for the development of an individualized neoantigen-based cancer vaccine that requires a manufacturing period for each patient.

The process of generating an individualized 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 individualized vaccine, and the manufacture and release of the individualized vaccine.

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 bio, provided that the patient meets the specified eligibility criteria for that treatment study.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
      • Tamarac, Florida, United States, 33321
        • Advanced Research
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newly-diagnosed or recurrent advanced/metastatic CRC who are initiating fluoropyrimidine and oxaliplatin (FOLFOX or CAPEOX) in combination with bevacizumab. Patients will then be assessed to determine if sufficient neoantigens are identified using Gritstone's proprietary prediction algorithm, EDGE(TM), to warrant manufacturing of an individualized vaccine.

High-risk Stage II or Stage III colon cancer who have MRD based on the presence of ctDNA following surgical resection. Patients with MRD will then be assessed to determine if sufficient neoantigens are identified using Gritstone's proprietary prediction algorithm, EDGE(TM), to warrant manufacturing of an individualized vaccine.

Description

ADVANCED/METASTATIC COLORECTAL CANCER

Inclusion Criteria:

  • signed and dated ICF prior to initiation of study-specific procedures
  • histologically confirmed metastatic CRC who are planned for or who have received no more than one cycle of first-line treatment in the advanced/metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab
  • measurable and unresectable disease according to RECIST v1.1
  • known KRAS status
  • availability of FFPE tumor specimens from biopsy within the previous 12 months for sequencing and neoantigen prediction
  • ≥ 12 years of age
  • ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age
  • adequate organ function (further defined in protocol)

Exclusion Criteria:

  • known microsatellite instability (MSI)hi disease based on institutional standard
  • known tumor mutation burden <1 nonsynonymous mutations/MB
  • patients with BRAF V600E mutations

LOCALIZED COLON CANCER

Inclusion Criteria:

  • signed and dated ICF prior to initiation of study-specific procedures
  • high-risk stage II or stage III colon cancer planned for or have completed surgical resection and have not initiated or received more than 4 weeks of adjuvant chemotherapy and be known ctDNA-positive via the Signatera assay
  • availability of FFPE tumor specimens for sequencing, determination of mutations for detecting and monitoring ctDNA to identify patients with minimal residual disease, and neoantigen prediction
  • ≥ 12 years of age
  • ECOG performance status of 0 or 1 or equivalent for patients of 12-17 years of age
  • adequate organ function (further defined in protocol)

Exclusion Criteria:

  • known microsatellite instability (MSI)hi disease based on institutional standard
  • known tumor mutation burden <1 nonsynonymous mutations/MB

Complete list of inclusion and exclusion criteria are listed in the clinical study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Advanced/Metastatic Colorectal Cancer
Eligible patients include those with newly-diagnosed or recurrent advanced/metastatic CRC who are initiating fluoropyrimidine and oxaliplatin (FOLFOX or CAPEOX) in combination with bevacizumab. Patients will then be assessed to determine if sufficient neoantigens are identified using Gritstone's proprietary prediction algorithm, EDGE(TM), to warrant manufacturing of an individualized vaccine. Patients with sufficient neoantigens will have vaccine manufactured while receiving FOLFOX or CAPEOX/bevacizumab.
Procedure: blood collection for research (next generation sequencing [NGS])
participants will have whole blood collected for NGS
Procedure: blood collection for research (HLA typing)
participants will have whole blood collected for HLA typing
Localized Colon Cancer
Eligible patients include those with high-risk Stage II or Stage III colon cancer who have MRD based on the presence of ctDNA following surgical resection. Patients with MRD will then be assessed to determine if sufficient neoantigens are identified using Gritstone's proprietary prediction algorithm, EDGE(TM), to warrant manufacturing of an individualized vaccine.
Procedure: blood collection for research (next generation sequencing [NGS])
participants will have whole blood collected for NGS
Procedure: blood collection for research (HLA typing)
participants will have whole blood collected for HLA typing
Procedure: blood collection for research (circulating tumor DNA [ctDNA])
participants will have whole blood collected for ctDNA detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary
Time Frame: at study enrollment
To identify patients with a defined tumor-specific profile (or tumor-specific characteristics, proteins, mutations) for potential inclusion in a separate clinical study that involves investigational study treatment.
at study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gritstone bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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