A Study of Personalized Neoantigen Cancer Vaccines

NCT03794128 | Completed

• 1 other identifier: GO-003
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

neoantigen cancer vaccine; personalized neoantigen cancer vaccine

Outcome Measures

Primary Outcomes (3)

• Group 1 only: Presence of neoantigens sufficient to warrant patient-specific vaccine manufacture

  At study enrollment

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

  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

  Up to approximately 2 weeks

Study Arms (2)

1 - patient-specific neoantigen cancer vaccine production

Procedure: Blood collection for research (next-generation sequencing [NGS]); Procedure: Blood collection for research (HLA typing)

2 - shared neoantigen cancer vaccine screening

Procedure: Blood collection for research (HLA typing)

Interventions

Blood collection for research (next-generation sequencing [NGS]) PROCEDURE

Participants will have whole blood collected for next-generation sequencing (NGS).

1 - patient-specific neoantigen cancer vaccine production

Blood collection for research (HLA typing) PROCEDURE

Participants will have whole blood collected for HLA typing.

1 - patient-specific neoantigen cancer vaccine production; 2 - shared neoantigen cancer vaccine screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncology

You may qualify if:

• 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:
• 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)
• GEA who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
• mUC who have received ≤ 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
• 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)
• 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)

You may not qualify if:

• Tumors with genetic characteristics as follows:
• For NSCLC, patients with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK
• For CRC or GEA, patients with MSI disease
• For CRC, patients with a known BRAF mutation or patients with peritoneal carcinomatosis
• 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:
• 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
• NSCLC who are currently receiving systemic treatment with cytotoxic, platinum-based chemotherapy in combination with an anti-PD-(L)1 antibody
• PDA who are currently receiving systemic cytotoxic chemotherapy as their first-line therapy for metastatic disease
• Patients with MSI disease
• Patients with NSCLC with a known driver genomic alteration in EGFR, ALK, ROS1, RET, or TRK

Sponsors & Collaborators

• Gritstone bio, Inc.: lead

Study Sites (5)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* 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)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Carcinoma, Transitional Cell

Interventions

High-Throughput Nucleotide Sequencing; Histocompatibility Testing

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 4, 2019
• Study Start: July 25, 2018
• Primary Completion: January 17, 2020
• Study Completion: May 26, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

US (5)