Overview

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

Status:
Active, not recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genocea Biosciences, Inc.
Treatments:
Nivolumab
Pembrolizumab
Vaccines
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 (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