Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03633110 |
Recruitment Status :
Completed
First Posted : August 16, 2018
Last Update Posted : April 19, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cutaneous Melanoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Urothelial Carcinoma Renal Cell Carcinoma | Biological: GEN-009 Adjuvanted Vaccine Drug: Nivolumab Drug: Pembrolizumab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | August 29, 2018 |
Actual Primary Completion Date : | December 8, 2021 |
Actual Study Completion Date : | February 28, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A
Participants in Part A have no evidence of disease when they begin receiving GEN-009 Adjuvanted Vaccine, and have completed treatment with curative intent for their disease (eg, surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation therapy). Part A will consist of approximately 9 participants. |
Biological: GEN-009 Adjuvanted Vaccine
GEN-009 Adjuvanted Vaccine consists of GEN-009 Drug Product mixed with Hiltonol (poly-ICLC, adjuvant) and is administered by subcutaneous injection. |
Experimental: Part B
Participants in Part B have advanced or metastatic solid tumors, and will receive GEN-009 Adjuvanted Vaccine in combination with PD-1 inhibitor therapy (nivolumab or pembrolizumab). Part B will consist of up to 90 participants. |
Biological: GEN-009 Adjuvanted Vaccine
GEN-009 Adjuvanted Vaccine consists of GEN-009 Drug Product mixed with Hiltonol (poly-ICLC, adjuvant) and is administered by subcutaneous injection. Drug: Nivolumab Nivolumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
Other Name: OPDIVO Drug: Pembrolizumab Pembrolizumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
Other Name: KEYTRUDA |
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1.5 years after first GEN-009 vaccination ]Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- T-cell responses to GEN-009 adjuvanted vaccine [ Time Frame: 1.5 years after first GEN-009 vaccination ]Immunogenicity based on T-cell responses to GEN-009
- Antitumor activity of GEN-009 in Part B [ Time Frame: 48 weeks after first GEN-009 vaccination ]Evaluation conducted based on RECIST v1.1 (and immune-related RECIST [irRECIST], where appropriate)
- Long-term clinical outcomes of Part A participants [ Time Frame: 1.5 years after first GEN-009 vaccination ]Disease recurrence
- Additional cellular responses after vaccination with GEN-009 [ Time Frame: 1 year after first GEN-009 vaccination ]Cytokine secretion
- Phenotype of circulating immune cells after vaccination with GEN-009 [ Time Frame: 1 year after first GEN-009 vaccination ]Measured by flow cytometry
- Tumor-infiltrating T cells after vaccination with GEN-009 [ Time Frame: 1 year after first GEN-009 vaccination ]Will be examined in tumor biopsies

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
General Inclusion Criteria:
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Diagnosis of 1 of the following tumor types:
- Melanoma (cutaneous).
- NSCLC.
- SCCHN (oral, oropharyngeal, hypopharyngeal, or laryngeal).
- Urothelial carcinoma.
- 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:
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Receiving or will initiate treatment with nivolumab or pembrolizumab per disease as listed below:
- 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
- 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.
- Cutaneous Melanoma: Patients with unresectable or metastatic cutaneous melanoma beginning nivolumab monotherapy or nivolumab in combination with ipilimumab.
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Urothelial Carcinoma: Patients with locally advanced or metastatic urothelial carcinoma who are beginning pembrolizumab who:
- 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
- Have had disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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Renal Cell Carcinoma:
- Patients with advanced RCC who have received prior anti-angiogenic therapy, and are beginning nivolumab monotherapy, OR
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633110
United States, California | |
UC San Diego Moores Cancer Center | |
La Jolla, California, United States, 92093 | |
John Wayne Cancer Institute - Providence Saint John's Health Center | |
Santa Monica, California, United States, 90404 | |
United States, Colorado | |
University of Colorado, Anschutz Cancer Pavilion | |
Aurora, Colorado, United States, 80045 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, New York | |
Columbia University Medical Center - Herbert Irving Pavilion | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
The Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
University of Wisconsin Carbone Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Director: | Arthur P. DeCillis, MD |
Responsible Party: | Genocea Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT03633110 |
Other Study ID Numbers: |
GEN-009-101 |
First Posted: | August 16, 2018 Key Record Dates |
Last Update Posted: | April 19, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Vaccine Personalized Immunotherapy Solid Tumor Personal Skin |
Lung Cancer Bladder Kidney Melanoma Carcinoma |
Carcinoma Melanoma Carcinoma, Renal Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Carcinoma, Squamous Cell |
Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Head and Neck Neoplasms Pembrolizumab Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |