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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03633110
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : October 8, 2019
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 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
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 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

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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)

Other Outcome Measures:
  1. Long-term clinical outcomes of Part A participants [ Time Frame: 1.5 years after first GEN-009 vaccination ]
    Disease recurrence

  2. Additional cellular responses after vaccination with GEN-009 [ Time Frame: 1 year after first GEN-009 vaccination ]
    Cytokine secretion

  3. Phenotype of circulating immune cells after vaccination with GEN-009 [ Time Frame: 1 year after first GEN-009 vaccination ]
    Measured by flow cytometry

  4. Tumor-infiltrating T cells after vaccination with GEN-009 [ Time Frame: 1 year after first GEN-009 vaccination ]
    Will be examined in tumor biopsies

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03633110

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Contact: Jessica Price 617-876-8191

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United States, Arizona
Scottsdale Healthcare Hospitals DBA HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, RN    480-323-1339   
Principal Investigator: Michael S. Gordon, MD         
Sub-Investigator: Jasgit Sachdev, MD         
Sub-Investigator: Erkut H. Borazanci, MD         
Sub-Investigator: Sunil Sharma, MD         
Sub-Investigator: Frank Y. Tsai, MD         
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Ashley Weaver    858-822-1962   
Principal Investigator: Sandip Patel, MD         
Sub-Investigator: Gregory Daniels, MD, PhD         
Sub-Investigator: Mina Nikanjam, MD, PhD         
Sub-Investigator: Lyudmila Bazhenova, MD         
Sub-Investigator: Kathryn Gold, MD         
Sub-Investigator: Ezra Cohen, MD         
Sub-Investigator: Assuntina Sacco, MD         
Sub-Investigator: Rana McKay, MD         
Sub-Investigator: James Randall, MD         
Sub-Investigator: Frederick Millard, MD         
Sub-Investigator: Shumei Kato, MD         
John Wayne Cancer Institute - Providence Saint John's Health Center Recruiting
Santa Monica, California, United States, 90404
Contact: Kelly Garver    310-582-7456   
Principal Investigator: Przemyslaw Twardowski, MD         
Sub-Investigator: Steven J. O'Day, MD         
Sub-Investigator: Trevan Fischer, MD         
Sub-Investigator: Jennifer Lineham, MD         
United States, Colorado
University of Colorado, Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristen Califano    720-848-0592   
Principal Investigator: Antonio Jimeno, MD, PhD         
Sub-Investigator: Daniel W. Bowles, MD         
Sub-Investigator: David R. Cambridge, MD, PhD         
Sub-Investigator: Bradley R. Corr, MD         
Sub-Investigator: Lindsey Davis, MD         
Sub-Investigator: Jennifer R. Diamond, MD         
Sub-Investigator: Lia Gore, MD         
Sub-Investigator: Gentry GT King, MD         
Sub-Investigator: Elaine T. Lam, MD         
Sub-Investigator: Alexis D. Leal, MD         
Sub-Investigator: Stephen Leong, MD         
Sub-Investigator: Karl D. Lewis, MD         
Sub-Investigator: Christopher H. Lieu, MD         
Sub-Investigator: Jessica McDermott, MD         
Sub-Investigator: Wells A. Messersmith, MD         
Sub-Investigator: Jose M. Pacheco, MD         
Sub-Investigator: Thomas W. Purcell, MD         
Sub-Investigator: Victor M. Villalobos, MD, PhD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Kristina Kelley    617-632-4976   
Principal Investigator: Mark Awad, MD, PhD         
Sub-Investigator: Frank S. Hodi, MD         
Sub-Investigator: Osama Rahma, MD         
Sub-Investigator: Patrick Ot, PhD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Nikita Patel    313-576-9723   
Principal Investigator: Ulka Vaishampayan, MD         
Sub-Investigator: Hirva Mamdani, MD         
Sub-Investigator: Amy Weise, MD         
Sub-Investigator: Misako Nagasaka, MD         
Sub-Investigator: Ira Winer, MD, PhD         
Sub-Investigator: Anteneh Tesfaye, MD         
Sub-Investigator: Anthony Shields, MD, PhD         
Sub-Investigator: Ammar Sukari, MD         
Sub-Investigator: Mary Josephine P Pilat, PhD         
Sub-Investigator: Joseph Uberti, MD, PhD         
Sub-Investigator: Abhinav Deol, MD         
Sub-Investigator: Voravit Ratanatharathorn, MD         
Sub-Investigator: Lois Ayash, MD         
Sub-Investigator: Asif Alavi, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Rudy Lackner, MD   
Principal Investigator: Rudy Lackner, MD         
Sub-Investigator: Alissa S Marr, MD         
Sub-Investigator: James K Schwarz, MD         
Sub-Investigator: Benjamin A Teply, MD         
Sub-Investigator: Vinicius Ernani, MD         
United States, New York
Columbia University Medical Center - Herbert Irving Pavilion Recruiting
New York, New York, United States, 10032
Contact: Fawzia Ibrahim    212-342-3970   
Principal Investigator: Mark Stein, MD         
Sub-Investigator: Richard D. Carvajal, MD         
Sub-Investigator: Gary K. Schwartz, MD         
Sub-Investigator: Kevin Kalinsky, MD         
Sub-Investigator: Charles Drake, MD, PhD         
Sub-Investigator: Emerson Lim, MD         
Sub-Investigator: June Hou, MD         
Sub-Investigator: Matthew Ingham, MD         
Sub-Investigator: Jessica Yang, MD         
Sub-Investigator: Meghna Trivedi, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maryann Redlinger    215-662-7452   
Principal Investigator: Roger Cohen, MD         
Sub-Investigator: Ronac Mantami, MD         
Sub-Investigator: Naomi Haas, MD         
Sub-Investigator: Vivek Narayan, MD         
Sub-Investigator: Charu Aggarwal, MD         
Sub-Investigator: Joshua Bauml, MD         
Sub-Investigator: Tara Mitchell, MD         
United States, Tennessee
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ask Sarah    615-339-4214   
Principal Investigator: Melissa L. Johnson, MD         
Sub-Investigator: Todd M. Bauer, MD         
Sub-Investigator: Johanna C. Bendell, MD         
Sub-Investigator: Howard A. Burris, III, MD         
Sub-Investigator: Erika P. Hamilton, MD         
Sub-Investigator: Saurin Chokshi, MD         
Sub-Investigator: Meredith A. McKean, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Debora Clay    713-745-0294   
Principal Investigator: Maura Gillison, MD, PhD         
Sub-Investigator: George Blumenschein Jr., MD         
Sub-Investigator: Lauren Byers, MD         
Sub-Investigator: Frank Fossella, MD         
Sub-Investigator: Don Gibbons, MD, PhD         
Sub-Investigator: Bonnie Glisson, MD         
Sub-Investigator: John Heymach Jr., MD, PhD         
Sub-Investigator: Jonathan Kurie, MD         
Sub-Investigator: George Simon, MD         
Sub-Investigator: Vassiliki Papadimitrakopoulou, MD         
Sub-Investigator: Faye Johnson, MD         
Sub-Investigator: Frank E Mott, MD         
Sub-Investigator: Charles Lu, MD         
Sub-Investigator: Jianjun Zhang, MD, PhD         
Sub-Investigator: Ferdinandos Skoulidis, MD, PhD         
Sub-Investigator: Vincent Lam, MD         
Sub-Investigator: Mehmet Altan, MD         
Sub-Investigator: Anne S Tsao, MD         
Sub-Investigator: Renata Ferrarotto, MD         
Sub-Investigator: Xiuning Le, MD         
Sub-Investigator: Diana Bell, MD         
Sub-Investigator: Jeffrey Myers, MD         
Sub-Investigator: Neil Gross, MD         
Sub-Investigator: Yasir Elamin, MD         
Sub-Investigator: Sanjay Gupta, MD         
Sub-Investigator: Michelle Williams, MD         
Sponsors and Collaborators
Genocea Biosciences, Inc.
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Study Director: Arthur P. DeCillis, MD

Additional Information:
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Responsible Party: Genocea Biosciences, Inc. Identifier: NCT03633110     History of Changes
Other Study ID Numbers: GEN-009-101
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genocea Biosciences, Inc.:
Solid Tumor
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Carcinoma, Squamous Cell
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Head and Neck Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents