- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03794128
A Study of Personalized Neoantigen Cancer Vaccines
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago Medicine Comprehensive Cancer Center
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Comprehensive Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology
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Virginia
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Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1 - patient-specific neoantigen cancer vaccine production
|
Participants will have whole blood collected for next-generation sequencing (NGS).
Participants will have whole blood collected for HLA typing.
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2 - shared neoantigen cancer vaccine screening
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Participants will have whole blood collected for HLA typing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture
Time Frame: At study enrollment
|
At study enrollment
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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
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Up to approximately 20 weeks
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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
|
Up to approximately 2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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