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BRIEF TITLE: Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine in Adult Patients With Selected Solid Tumors

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

  • Org Study ID: GEN-009-101
  • Secondary ID:
  • NCT ID: NCT03633110
  • NCT Alias:
  • Sponsor: Genocea Biosciences, Inc. - Industry
  • Source: Genocea Biosciences, Inc.

Brief Summary

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).

Detailed Description

This first-in-human study of GEN-009 will be conducted in two 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 (Part B 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 a PD-1 inhibitor
therapy (nivolumab or pembrolizumab) at the approved dose and schedule per the United States
Package Insert (USPI). In addition, up to 15 patients who enroll in one of the Part B
disease-specific cohorts but whose disease progresses during the screening period therapy may
be enrolled into a separate relapsed/refractory disease cohort.

Overal Status Start Date Phase Study Type
Recruiting August 29, 2018 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of Treatment-Emergent Adverse Events

Primary Outcome 1 - Time Frame: 1.5 years after first GEN-009 vaccination

Primary Outcome 2 - Measure: T-cell responses to GEN-009 adjuvanted vaccine

Primary Outcome 2 - Time Frame: 1.5 years after first GEN-009 vaccination


  • Cutaneous Melanoma
  • Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Urothelial Carcinoma
  • Renal Cell Carcinoma


General Inclusion Criteria:

- Diagnosis of 1 of the following tumor types:

1. Melanoma (cutaneous).


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

4. Urothelial carcinoma.

5. Renal cell carcinoma (Part B 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 nivolumab or pembrolizumab per disease as
listed below:

1. NSCLC: Patients with metastatic non-squamous NSCLC beginning first-line
pembrolizumab in combination with pemetrexed and platinum chemotherapy, or
metastatic squamous NSCLC beginning first-line pembrolizumab in combination with
carboplatin and either paclitaxel or nab-paclitaxel

2. SCCHN: Patients beginning pembrolizumab with recurrent or metastatic SCCHN with
disease progression on or after a platinum-based therapy, or beginning first-line
pembrolizumab for recurrent or metastatic SCCHN if tumors express PD-L1 with a
Combined Positive Score (CPS) ≥ 1.

3. Cutaneous Melanoma: Patients with unresectable or metastatic cutaneous melanoma
beginning nivolumab monotherapy or nivolumab in combination with ipilimumab.

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

1. Are not eligible for cisplatin-containing chemotherapy, and tumor is PD-L1
positive with CPS ≥ 10, or are not eligible for any platinum-containing
chemotherapy, OR

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

5. Renal Cell Carcinoma:

1. Patients with advanced RCC who have received prior anti-angiogenic therapy,
and are beginning nivolumab monotherapy, OR

2. Untreated patients with intermediate or poor risk RCC based on the IMDC
score who are beginning nivolumab in combination with ipilimumab.

- 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

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

- Patient has received cytotoxic chemotherapy within 4 weeks of the first leukapheresis

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Arthur P. DeCillis, MD

Role: Study Director


Overall Contact

Name: Jessica Price

Phone: 617-876-8191


Link: OPDIVO (nivolumab) United States Prescribing Information


Facility Status Contact
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer, RN
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
Recruiting Ashley Weaver
John Wayne Cancer Institute - Providence Saint John's Health Center
Santa Monica, California 90404
United States
Recruiting Kelly Garver
University of Colorado, Anschutz Cancer Pavilion
Aurora, Colorado 80045
United States
Recruiting Kristen Califano
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Kristina Kelley
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Nikita Patel
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Recruiting Rudy Lackner, MD
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United States
Recruiting Fawzia Ibrahim
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Recruiting Maryann Redlinger
The Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Ask Sarah
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Debora Clay