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Brief Title: 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

INTRODUCTION

  • Org Study ID: GO-003
  • Secondary ID: N/A
  • NCT ID: NCT03794128
  • Sponsor: Gritstone Oncology, Inc.

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.


  • Overall Status
    Recruiting
  • Start Date
    July 25, 2018
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture

Primary Outcome 1 - Timeframe: At study enrollment

Primary Outcome 2 - Measure: Group 1 only: Percentage of patients for whom patient-specific vaccine is successfully manufactured (defined as meeting release criteria)

Primary Outcome 2 - Timeframe: Up to approximately 20 weeks

Primary Outcome 3 - Measure: 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

Primary Outcome 3 - Timeframe: Up to approximately 2 weeks

CONDITION

  • Non Small Cell Lung Cancer
  • Colorectal Cancer
  • Gastroesophageal Adenocarcinoma
  • Urothelial Carcinoma
  • Pancreatic Ductal Adenocarcinoma

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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 857-327-9816

Email: aferguson@gritstone.com

LOCATION

Facility Status Contact
Facility: University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois 60637
United States 		Status: Recruiting Contact: Aurelie Desgardin
adesgard@medicine.bsd.uchicago.edu
Facility: Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York 10032
United States 		Status: Recruiting Contact: Raquel Gindi-Kolker
rg3223@cumc.columbia.edu
Facility: The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States 		Status: Recruiting Contact: Carly Pilcher
carly.pilcher@osumc.edu
Facility: Tennessee Oncology
Nashville, Tennessee 37203
United States 		Status: Recruiting Contact: Dee McComb
davinia.mccomb@sarahcannon.com
Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States 		Status: Recruiting Contact: Marcy Sullivan
marcy.sullivan@usoncology.com

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