Colon Cancer Clinical Trial
A Screening Study Targeting Tumor-specific Antigens
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.
Full 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.
Eligibility Criteria
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
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There are 6 Locations for this study
Miami Florida, 33176, United States
Tamarac Florida, 33321, United States
East Brunswick New Jersey, 08816, United States
Cincinnati Ohio, 45219, United States
Nashville Tennessee, 37203, United States
Fairfax Virginia, 22031, United States
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