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BRIEF 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

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 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.

Overal Status Start Date Phase Study Type
Recruiting August 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

Condition:

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

Eligibility

Criteria:
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 additional anticancer treatment 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Jennifer LaVin

Phone: 617-876-8191

Email: jennifer.lavin@genocea.com

Link: OPDIVO (nivolumab) United States Prescribing Information

Locations

Facility Status Contact
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona 85258
United States
Recruiting Paul McKinney
480-323-3805
paul.mckinney@honorhealth.com
The Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Scott Ramsey
615-524-4384
scott.ramsey@sarahcannon.com