A Screening Study Targeting Tumor-specific Antigens

NCT05158621 | Completed

• 1 other identifier: GO-007
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer; Stage II/III Colon Cancer

Keywords

personalized neoantigen cancer vaccine; neoantigen cancer vaccine; individualized immunotherapy

Outcome Measures

Primary Outcomes (1)

• Primary

  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

Study Arms (2)

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]); Procedure: blood collection for research (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]); Procedure: blood collection for research (HLA typing); Procedure: blood collection for research (circulating tumor DNA [ctDNA])

Interventions

blood collection for research (next generation sequencing [NGS]) PROCEDURE

participants will have whole blood collected for NGS

Advanced/Metastatic Colorectal Cancer; Localized Colon Cancer

blood collection for research (HLA typing) PROCEDURE

participants will have whole blood collected for HLA typing

Advanced/Metastatic Colorectal Cancer; Localized Colon Cancer

blood collection for research (circulating tumor DNA [ctDNA]) PROCEDURE

participants will have whole blood collected for ctDNA detection

Localized Colon Cancer

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Gritstone bio, Inc.: lead

Study Sites (6)

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Advanced Research

Tamarac, Florida, 33321, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Sarah Cannon

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

High-Throughput Nucleotide Sequencing; Histocompatibility Testing; Circulating Tumor DNA

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Cell-Free Nucleic Acids; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; DNA, Neoplasm; DNA

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: December 14, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

US (6)