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A Study of Personalized Neoantigen Cancer Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794128
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Gritstone Oncology, Inc.

Tracking Information
First Submitted Date December 18, 2018
First Posted Date January 4, 2019
Last Update Posted Date August 13, 2019
Actual Study Start Date July 25, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
  • 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 ]
Original Primary Outcome Measures
 (submitted: January 2, 2019)
  • Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture [ Time Frame: At study enrollment ]
  • Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria) [ Time Frame: Up to approximately 20 weeks ]
Change History Complete list of historical versions of study NCT03794128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • whole blood specimen, for HLA typing (all participants)
  • FFPE tumor material from a biopsy or resection, for sequencing to identify tumor-specific mutations (Group 1 participants only)
  • whole blood specimen, for sequencing of normal genome (Group 1 participants only)
Sampling Method Non-Probability Sample
Study Population Oncology
Condition
  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • Gastroesophageal Adenocarcinoma
  • Urothelial Carcinoma
  • Pancreatic Ductal Adenocarcinoma
Intervention
  • Procedure: Blood collection for research (next-generation sequencing [NGS])
    Participants will have whole blood collected for next-generation sequencing (NGS).
  • Procedure: Blood collection for research (HLA typing)
    Participants will have whole blood collected for HLA typing.
Study Groups/Cohorts
  • 1 - patient-specific neoantigen cancer vaccine production
    Interventions:
    • Procedure: Blood collection for research (next-generation sequencing [NGS])
    • Procedure: Blood collection for research (HLA typing)
  • 2 - shared neoantigen cancer vaccine screening
    Intervention: Procedure: Blood collection for research (HLA typing)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2019)
140
Original Estimated Enrollment
 (submitted: January 2, 2019)
40
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Andy Ferguson 857-327-9816 aferguson@gritstone.com
Contact: Cynthia Voong 510-871-6104 cvoong@gritstone.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03794128
Other Study ID Numbers GO-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gritstone Oncology, Inc.
Study Sponsor Gritstone Oncology, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Gritstone Oncology, Inc.
Verification Date August 2019