Status:
COMPLETED
A Study of Personalized Neoantigen Cancer Vaccines
Lead Sponsor:
Gritstone bio, Inc.
Conditions:
Non Small Cell Lung Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief 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 ...
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 ca...
Eligibility Criteria
Inclusion
- Group 1
- 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
- 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.
Key Trial Info
Start Date :
July 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03794128
Start Date
July 25 2018
End Date
May 26 2020
Last Update
September 11 2020
Active Locations (5)
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1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
2
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
3
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
4
Tennessee Oncology
Nashville, Tennessee, United States, 37203