Colorectal Cancer Clinical Trial
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
NCT number | NCT03794128 |
Other study ID # | GO-003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 25, 2018 |
Est. completion date | May 26, 2020 |
Verified date | September 2020 |
Source | Gritstone Oncology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 93 |
Est. completion date | May 26, 2020 |
Est. primary completion date | January 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: 1. 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) 2. GEA who have received = 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 3. mUC who have received = 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy 4. 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: 1. For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK 2. For CRC or GEA, patients with MSI disease 3. 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: 1. 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 2. NSCLC who are currently receiving systemic treatment with cytotoxic, platinum-based chemotherapy in combination with an anti-PD-(L)1 antibody 3. 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois |
United States | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Virginia Cancer Specialists | Fairfax | Virginia |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Gritstone Oncology, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture | At study enrollment | ||
Primary | Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria) | Up to approximately 20 weeks | ||
Primary | 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 | Up to approximately 2 weeks |
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