Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine



Status:Recruiting
Conditions:Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:August 29, 2018
End Date:December 2022
Contact:Jennifer LaVin
Email:jennifer.lavin@genocea.com
Phone:617-876-8191

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A Phase 1/2a Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine in Adult Patients With Selected Solid Tumors

In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine,
GEN-009, that is being developed for the treatment of patients with solid tumors. A
proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will
be used to identify neoantigens in each patient's tumor that are recognized by their CD4
and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's
personalized vaccine in the form of synthetic long peptides (SLPs).

This first-in-human study of GEN-009 will be conducted in three parts in adult patients with
cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head
and neck (SCCHN), urothelial carcinoma, or renal cell carcinoma (Parts B and C only). In Part
A, the safety and immunogenicity of single-agent GEN-009 will be evaluated in patients with
the above-noted tumor types who have completed treatment with curative intent for their
disease (eg, surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation
therapy) and have no evidence of disease (NED) at the time of initiating vaccination with
GEN-009. In Part B, up to 15 patients in each disease cohort will be enrolled and evaluated
for safety, immunogenicity, and preliminary antitumor activity of GEN-009. Patients in Part B
will receive GEN-009 at the schedule selected in Part A, in combination with nivolumab at the
approved dose and schedule per the United States Package Insert (USPI). Part C will evaluate
the safety, immunogenicity, and objective response rate (ORR) of patients with the
above-noted tumor types who have received at least 1 line of standard systemic therapy that
included a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1)
inhibitor for advanced, recurrent, or metastatic disease.

General Inclusion Criteria:

- Diagnosis of 1 of the following tumor types:

1. Melanoma (cutaneous).

2. NSCLC.

3. SCCHN (oral, oropharyngeal, hypopharyngeal, or laryngeal).

4. Urothelial carcinoma.

5. Renal cell carcinoma (Parts B and C only).

- Understand the study, be willing to comply with all study procedures and sign the
informed consent

- Adequate tumor tissue available

- ECOG performance status of 0 or 1

- Negative pregnancy test (females of childbearing potential)

- Agree to use of contraception during the study until at least 90 days after final
GEN-009 dose

- Adequate hematologic, liver, and kidney function

Part A-specific Inclusion:

- Have completed or will complete treatment for their disease with curative intent

- Have no evidence of disease

Part B-specific Inclusion:

- Receiving or will initiate treatment with full-dose nivolumab per disease as listed
below:

1. NSCLC: Patients with metastatic NSCLC with disease progression on or after
platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations
should have had disease progression on FDA-approved therapy for these aberrations
prior to receiving nivolumab

2. SCCHN: Patients with recurrent or metastatic SCCHN with disease progression on or
after a platinum-based therapy

3. Cutaneous Melanoma: Patients with unresectable or metastatic cutaneous melanoma
regardless of BRAF mutation status

4. Urothelial Carcinoma: Patients with locally advanced or metastatic urothelial
carcinoma who:

1. Have had disease progression during or following platinum-containing
chemotherapy

2. Have disease progression within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy

5. Renal Cell Carcinoma: Patients with advanced renal cell carcinoma who have
received prior anti-angiogenic therapy.

- Disease assessment by CT or MRI

- Have at least 1 lesion that is measureable by RECIST 1.1

- Agree to a tumor biopsy 50 days after first GEN-009 vaccination

- Participants with hypothyroidism must be on thyroid replacement treatment

Part C-specific Inclusion:

- Have received at least 1 line of standard systemic therapy for advanced, relapsed, or
metastatic disease

- Have received a PD-1 or PD-L1 inhibitor either as a single-agent or in combination,
and have had disease progression on the checkpoint inhibitor or disease that is
considered by the Investigator to be refractory to the checkpoint inhibitor

- In addition, Part C participants should have received the following chemotherapy:

1. NSCLC: A platinum-containing chemotherapy regimen

2. SCCHN: A platinum-containing chemotherapy regimen

3. Cutaneous Melanoma with a BRAF V600 mutation: An FDA-approved BRAF inhibitor

4. Urothelial carcinoma: A platinum-containing chemotherapy regimen.

5. Renal Cell Carcinoma: An anti-angiogenic therapy

- Have at least 1 lesion that is measureable by RECIST 1.1

- Agree to a tumor biopsy 50 days after first GEN-009 vaccination

General Exclusion Criteria:

- Received a live vaccine ≤ 28 days, or a non-live vaccine ≤ 14 days, prior to the first
dose of GEN-009

- Acute or chronic skin disorders that would interfere with injection

- Receiving immunosuppressive therapies or systemic corticosteroids. Note: Use of
topical corticosteroids or inhaled corticosteroids is acceptable

- Allergy to the vaccine adjuvant Hiltonol (poly-ICLC)

- Active hepatitis B or hepatitis C infection

- HIV Positive

- History of clinically significant cardiac condition

- History of leptomeningeal carcinomatosis

- Had clinically active immune-mediated disease within 5 years

- Received a prior allogeneic stem cell transplant

- Has primary immune deficiency

- Received a prior solid organ transplant

- Has malignant disease, other than the tumor types being treated in this study

- Female patient who is pregnant, breastfeeding, or who plans to become pregnant from
the signing of the informed consent until ≥ 90 days from last dose of GEN-009

- Any condition that in the judgment of the PI would make the patient inappropriate for
enrollment in the study

Part A-specific Exclusion Criteria:

- Has received or requires more than 2 adjuvant or neoadjuvant regimens (other than
surgical excisions) given with curative intent prior to first GEN-009 vaccination

- Has not recovered or stabilized from any clinically significant toxicity associated
with any prior procedure or anticancer therapy

Part B-specific Exclusion Criteria:

- Has received or requires additional anticancer treatment prior to first GEN-009
vaccination (however, these participants may be eligible for Part C)

Part C-specific Exclusion Criteria:

- Has received or requires additional anticancer treatment within 14 days of first
GEN-009 vaccination

- Has not recovered or stabilized from any clinically significant toxicity associated
with any prior procedure or anticancer therapy
We found this trial at
10
sites
2200 Santa Monica Boulevard
Santa Monica, California 90404
Principal Investigator: Przemyslaw Twardowski, MD
Phone: 310-449-5224
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Santa Monica, CA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Roger Cohen, MD
Phone: 215-662-7452
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Aurora, Colorado 80045
Principal Investigator: Antonio Jimeno, MD, PhD
Phone: 720-848-0592
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Aurora, CO
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Mark Awad, MD, PhD
Phone: 617-632-4976
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Detroit, Michigan 48201
Principal Investigator: Ulka Vaishampayan, MD
Phone: 313-576-8411
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Detroit, MI
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Maura Gillison, MD, PhD
Phone: 713-745-0294
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
Principal Investigator: Sandip Patel, MD
Phone: 858-822-1962
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Melissa L. Johnson, MD
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New York, New York 10032
Principal Investigator: Mark Stein, MD
Phone: 212-342-3970
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New York, NY
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Scottsdale, Arizona 85258
Principal Investigator: Michael S. Gordon, MD
Phone: 480-323-1339
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Scottsdale, AZ
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