Non Small Cell Lung CancerNCT03794128
A Study of Personalized Neoantigen Cancer Vaccines
An observational study of Non Small Cell Lung Cancer and Colorectal Cancer, run by Gritstone bio, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is 1) to evaluate the feasibility of manufacturing a patient-specific neoantigen cancer vaccine, which involves predicting the patient's neoantigens and generating a vaccine that encodes the predicted neoantigens; and, 2) to identify and select patients who may be eligible for a shared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Colorectal Cancer, Gastroesophageal Adenocarcinoma
- What is being tested?
- Blood collection for research (next-generation sequencing [NGS]) and Blood collection for research (HLA typing)
- Type of treatment
- Surgery or procedure
- How many people
- 93 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jul 2018to 26 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncology
Group 1 Inclusion Criteria:
- Provide a signed and dated informed consent form prior to initiation of study-specific procedures
- Patients with the indicated advanced or metastatic solid tumor as follows:
- NSCLC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (Note: patients with NSCLC who are receiving pembrolizumab monotherapy as first line systemic monotherapy are eligible)
- GEA who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
- mUC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
- CRC-microsatellite stable (MSS) who have received ≤ 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan (Note: patients receiving first-line systemic therapy are eligible)
- 18 years of age or older
- ECOG Performance Status 0 or 1
- Available FFPE tumor specimen for sequencing and neoantigen selection
- Measurable disease according to RECIST v1.1 Have adequate organ function, as measured by laboratory values (criteria listed in protocol)
Group 1 Exclusion Criteria:
- Tumors with genetic characteristics as follows:
- For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK
- For CRC or GEA, patients with MSI disease
- For CRC, patients with a known BRAF mutation or patients with peritoneal carcinomatosis
Group 2 Inclusion Criteria:
- Provide a signed and dated informed consent form prior to initiation of study-specific procedures
- Patient's tumor possesses one of the mutations listed in the clinical study protocol, as determined per local institutional standard
- Patients with an advanced or metastatic solid tumor as follows:
- MSS-CRC who are currently receiving systemic treatment with a fluoropyrimidine and oxaliplatin or irinotecan that may include a VEGF or EGFR targeting therapy as their first-line or second-line therapy for metastatic disease
- NSCLC who are currently receiving systemic treatment with cytotoxic, platinum-based chemotherapy in combination with an anti-PD-(L)1 antibody
- PDA who are currently receiving systemic cytotoxic chemotherapy as their first-line therapy for metastatic disease
Group 2 Exclusion Criteria
- Patients with MSI disease
- Patients with NSCLC with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK
Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Tennessee Oncology
Nashville, Tennessee, 37203
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
About this study
Official title: An Observational Feasibility Study for the Production of a Patient-Specific Neoantigen Cancer Vaccine and Screening Study for a Shared Neoantigen Cancer Vaccine in Patients With Advanced Cancer
The purpose of this study is 1) to evaluate the feasibility of manufacturing a patient-specific neoantigen cancer vaccine, which involves predicting the patient's neoantigens and generating a vaccine that encodes the predicted neoantigens; and, 2) to identify and select patients who may be eligible for a shared neoantigen cancer vaccine where their tumor contains a specific shared mutation and who have the correct HLA allele capable of presenting the neoantigen derived from the tumor-specific mutation.
Read the detailed description
Gritstone is developing two neoantigen-based cancer vaccines: the first is a patient-specific cancer vaccine that requires a manufacturing period for each patient and the second is an off-the-shelf cancer vaccine that targets shared neoantigens.
The process of generating a patient-specific 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 patient-specific vaccine, and the manufacture and release of the patient-specific vaccine. Gaining experience in managing the manufacturing process will provide important insights and experience regarding this process to be used in operationalizing future clinical trials.
Selecting patients who may be eligible to receive a shared neoantigen vaccine requires first identifying patients whose tumor possesses a neoantigen derived from an oncogenic mutation that is encoded by the vaccine, and then determining whether the patient expresses a matching HLA allele for antigen presentation.
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 Oncology, provided that the patient meets the specified eligibility criteria for that treatment study.
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Gastroesophageal Adenocarcinoma, Urothelial Carcinoma, Pancreatic Ductal Adenocarcinoma
- Being tested
- Blood collection for research (next-generation sequencing [NGS]), Blood collection for research (HLA typing)
- Keywords
- neoantigen cancer vaccine, personalized neoantigen cancer vaccine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Carcinoma, Transitional Cell
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 next-generation sequencing (NGS).
Blood collection for research (HLA typing)Procedure or surgery
Participants will have whole blood collected for HLA typing.
| Study group | Role | What they receive |
|---|---|---|
| 1 - patient-specific neoantigen cancer vaccine production | Not described Receives: Procedure: Blood collection for research (next-generation sequencing [NGS]); Procedure: Blood collection for research (HLA typing) | |
| 2 - shared neoantigen cancer vaccine screening | Not described Receives: Procedure: Blood collection for research (HLA typing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture
Measured: At study enrollment
Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria)
Measured: Up to approximately 20 weeks
Group 2 only: Percentage of patients with at least one of the twenty specified shared mutations contained in the expression cassette and a matching HLA allele for neoantigen presentation
Measured: Up to approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start25 Jul 2018
- Primary completion17 Jan 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung 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
- 93 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
- NCT03794128
- Sponsor's protocol ID
- GO-003
- Status last verified
- Sep 2020
- First submitted
- 18 Dec 2018
- Last updated
- 11 Sep 2020
- 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 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Feasibility Study for the Production of a Patient-Specific Neoantigen Cancer Vaccine and Screening Study for a Shared Neoantigen Cancer Vaccine in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03794128
- Acronym / sponsor ID
- GO-003
- Conditions
- Non Small Cell Lung Cancer, Colorectal Cancer, Gastroesophageal Adenocarcinoma, Urothelial Carcinoma, Pancreatic Ductal Adenocarcinoma
- Keywords
- neoantigen cancer vaccine, personalized neoantigen cancer vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Gritstone bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 4 Jan 2019 (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 1) to evaluate the feasibility of manufacturing a patient-specific neoantigen cancer vaccine, which involves predicting the patient's neoantigens and generating a vaccine that encodes the predicted neoantigens; and, 2) to identify and select patients who may be eligible for a shared neoantigen cancer vaccine where their tumor contains a specific shared mutation and who have the correct HLA allele capable of presenting the neoantigen derived from the tumor-specific mutation.
Detailed description
Gritstone is developing two neoantigen-based cancer vaccines: the first is a patient-specific cancer vaccine that requires a manufacturing period for each patient and the second is an off-the-shelf cancer vaccine that targets shared neoantigens.
The process of generating a patient-specific 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 patient-specific vaccine, and the manufacture and release of the patient-specific vaccine. Gaining experience in managing the manufacturing process will provide important insights and experience regarding this process to be used in operationalizing future clinical trials.
Selecting patients who may be eligible to receive a shared neoantigen vaccine requires first identifying patients whose tumor possesses a neoantigen derived from an oncogenic mutation that is encoded by the vaccine, and then determining whether the patient expresses a matching HLA allele for antigen presentation.
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 Oncology, 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 |
|---|---|---|
| 1 - patient-specific neoantigen cancer vaccine production | – | Procedure: Blood collection for research (next-generation sequencing [NGS]), Procedure: Blood collection for research (HLA typing) |
| 2 - shared neoantigen cancer vaccine screening | – | Procedure: Blood collection for research (HLA typing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncology
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 next-generation sequencing (NGS). | Procedure or surgery | 1 - patient-specific neoantigen cancer vaccine production |
| Blood collection for research (HLA typing)Participants will have whole blood collected for HLA typing. | Procedure or surgery | 1 - patient-specific neoantigen cancer vaccine production, 2 - shared neoantigen cancer vaccine screening |
Primary outcome
Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture
Time frame: At study enrollment
Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria)
Time frame: Up to approximately 20 weeks
Group 2 only: Percentage of patients with at least one of the twenty specified shared mutations contained in the expression cassette and a matching HLA allele for neoantigen presentation
Time frame: Up to approximately 2 weeks
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 11 Sep 2020.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer and Colorectal Cancer, run by Gritstone bio, Inc. at 5 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?
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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture (time frame: At study enrollment). The study lists 3 primary outcomes in all. 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 11 Sep 2020.