Metastatic Colorectal CancerNCT05158621
A Screening Study Targeting Tumor-specific Antigens
An observational study of Metastatic Colorectal Cancer and Stage II/III Colon Cancer, run by Gritstone bio, Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Stage II/III Colon Cancer
- What is being tested?
- blood collection for research (next generation sequencing [NGS]), blood collection for research (HLA typing) and blood collection for research (circulating tumor DNA [ctDNA])
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 22 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Dec 2021to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
- 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
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Astera Cancer Care
East Brunswick, New Jersey, 08816
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Miami Cancer Institute
Miami, Florida, 33176
Sarah Cannon
Nashville, Tennessee, 37203
Advanced Research
Tamarac, Florida, 33321
About this study
Official title: A Screening Study for the Selection of Patients for Clinical Studies Targeting Tumor-specific Antigens
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.
- Being tested
- blood collection for research (next generation sequencing [NGS]), blood collection for research (HLA typing), blood collection for research (circulating tumor DNA [ctDNA])
- Keywords
- personalized neoantigen cancer vaccine, neoantigen cancer vaccine, individualized immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collection for research (next generation sequencing [NGS])Procedure or surgery
participants will have whole blood collected for NGS
blood collection for research (HLA typing)Procedure or surgery
participants will have whole blood collected for HLA typing
blood collection for research (circulating tumor DNA [ctDNA])Procedure or surgery
participants will have whole blood collected for ctDNA detection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start14 Dec 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gritstone bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158621
- Sponsor's protocol ID
- GO-007
- Status last verified
- Oct 2022
- First submitted
- 2 Dec 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Screening Study for the Selection of Patients for Clinical Studies Targeting Tumor-specific Antigens
- ClinicalTrials.gov ID
- NCT05158621
- Acronym / sponsor ID
- GO-007
- Keywords
- personalized neoantigen cancer vaccine, neoantigen cancer vaccine, individualized immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Gritstone bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced/Metastatic Colorectal Cancer | – | Procedure: blood collection for research (next generation sequencing [NGS]), Procedure: blood collection for research (HLA typing)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. |
| Localized Colon Cancer | – | 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])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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- known microsatellite instability (MSI)hi disease based on institutional standard
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collection for research (next generation sequencing [NGS])participants will have whole blood collected for NGS | Procedure or surgery | Advanced/Metastatic Colorectal Cancer, Localized Colon Cancer |
| blood collection for research (HLA typing)participants will have whole blood collected for HLA typing | Procedure or surgery | Advanced/Metastatic Colorectal Cancer, Localized Colon Cancer |
| blood collection for research (circulating tumor DNA [ctDNA])participants will have whole blood collected for ctDNA detection | Procedure or surgery | Localized Colon Cancer |
Primary outcome
Primary
Time frame: at study enrollment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Stage II/III Colon Cancer, run by Gritstone bio, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: at study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.