Brief Title
A Study of Personalized Neoantigen Cancer Vaccines
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
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 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 Type
Observational
Primary Outcome
Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture
Condition
Non Small Cell Lung Cancer
Intervention
Blood collection for research (next-generation sequencing [NGS])
Study Arms / Comparison Groups
1 - patient-specific neoantigen cancer vaccine production
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
93
Start Date
July 25, 2018
Completion Date
May 26, 2020
Primary Completion Date
January 17, 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03794128
Organization ID
GO-003
Responsible Party
Sponsor
Study Sponsor
Gritstone bio, Inc.
Study Sponsor
, ,
Verification Date
September 2020