A Study of Personalized Neoantigen Cancer Vaccines

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBlood collection for research (next-generation sequencing [NGS]) and Blood collection for research (HLA typing)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 11, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Gritstone bio, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Gritstone bio, Inc.
Interventions being studied: Procedure: Blood collection for research (next-generation sequencing [NGS]); Procedure: Blood collection for research (HLA typing)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Cell or gene therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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: 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois
Columbia University Medical Center, Herbert Irving Comprehensive Cancer CenterNew York, New York
The Ohio State University Comprehensive Cancer CenterColumbus, Ohio
Tennessee OncologyNashville, Tennessee
Virginia Cancer SpecialistsFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 11, 2020. Always confirm current availability with the study team.

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