Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
22 participants
OBSERVATIONAL
2021-12-14
2022-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PATHFINDER 2: a Multi-Cancer Early Detection Study
NCT05155605
Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment
NCT02105168
Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
NCT00806650
Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors
NCT02215928
PRospective REgistry of Advanced Stage CancER (PREFER) Patients to Assess Prevalence of Actionable Biomarkers and Driver Mutations to Address Disparities in Precision Medicine
NCT05697198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* 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 tumor mutation burden \<1 nonsynonymous mutations/MB
* patients with BRAF V600E mutations
LOCALIZED COLON CANCER
* known microsatellite instability (MSI)hi disease based on institutional standard
* known tumor mutation burden \<1 nonsynonymous mutations/MB
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gritstone bio, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Miami Cancer Institute
Miami, Florida, United States
Advanced Research
Tamarac, Florida, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
The Christ Hospital
Cincinnati, Ohio, United States
Sarah Cannon
Nashville, Tennessee, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GO-007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.