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CompletedNCT05158621Updated Oct 18, 2022

A Screening Study Targeting Tumor-specific Antigens

An observational study in Metastatic Colorectal Cancer and Stage II/III Colon Cancer, sponsored by Gritstone bio, Inc.. Completed at 6 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-10-18.

Sponsored by Gritstone bio, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metastatic Colorectal Cancer
  • Stage II/III Colon Cancer

Keywords

  • personalized neoantigen cancer vaccine
  • neoantigen cancer vaccine
  • individualized immunotherapy
03

In context

Colorectal Neoplasms

5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.

This study's enrollment of 22 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Gritstone bio, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedureblood collection for research (next generation sequencing [NGS])

    participants will have whole blood collected for NGS

  • Procedureblood collection for research (HLA typing)

    participants will have whole blood collected for HLA typing

  • Procedureblood collection for research (circulating tumor DNA [ctDNA])

    participants will have whole blood collected for ctDNA detection

06

What researchers measure

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.

    Time frame: at study enrollment

07

Study locations

6 sites
  • Miami Cancer Institute
    Miami, Florida 33176, United States
  • Advanced Research
    Tamarac, Florida 33321, United States
  • Astera Cancer Care
    East Brunswick, New Jersey 08816, United States
  • The Christ Hospital
    Cincinnati, Ohio 45219, United States
  • Sarah Cannon
    Nashville, Tennessee 37203, United States
  • Virginia Cancer Specialists
    Fairfax, Virginia 22031, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Aug 2022, 8 months.

Of 101 industry-sponsored observational studies under Colorectal Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 64. This study's 8 months is below that.

Counting every sponsor, half of 563 studies reached it within 53 months; a quarter within 28 and three quarters within 103.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2021
First posted
Dec 15, 2021
StartActual
Dec 14, 2021
Primary completionActual
Aug 15, 2022
CompletionActual
Aug 15, 2022
Last update
Oct 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05158621
Lead sponsor
Gritstone bio, Inc.
Responsible party
Sponsor
First posted
Dec 15, 2021
Start date
Dec 14, 2021
Primary completion
Aug 15, 2022
Completion
Aug 15, 2022
Last update
Oct 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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