A Screening Study Targeting Tumor-specific Antigens

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158621
• Other study ID #: GO-007
• Status: Completed
• Start date: December 14, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: October 2022
• Source: Gritstone bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Procedure:
• blood collection for research (next generation sequencing [NGS])
participants will have whole blood collected for NGS
• blood collection for research (HLA typing)
participants will have whole blood collected for HLA typing
• blood collection for research (circulating tumor DNA [ctDNA])
participants will have whole blood collected for ctDNA detection

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Miami Cancer Institute	Miami	Florida
United States	Sarah Cannon	Nashville	Tennessee
United States	Advanced Research	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gritstone bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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