Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies

NCT02721043 | Completed Phase 1 DMC

• 1 other identifier: GCO 15-1811
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety, tolerability, and immunogenicity of Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence. Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant Poly-ICLC is added to boost the immune response to the peptides and together will expand immune cells to target cancer.

Conditions

Solid Tumors

Keywords

Personalized vaccine; Poly-ICLC; Immunotherapy; Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities (DLT)

  toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale

  up to day 42

• Toxicity grading using CTCAE scale

  safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale

  one year

Study Arms (1)

Personalized Genome Vaccine 001

EXPERIMENTAL

PGV-001 (peptides + Poly-ICLC) Peptides: 100mcg per peptide per dose. Poly-ICLC (Hiltonol®, Oncovir): 1.4mg (0.7mL, 2mg/mL)

Biological: Peptides; Drug: Poly-ICLC; Drug: Lenalidomide

Interventions

Peptides BIOLOGICAL

Each subject will receive ten (10) total doses of PGV001. PGV001 will be administered on study visit: v4, v6, v8, v10, v12, v14, v16, v18, v20 and v22.

Also known as: Personalized Genome Vaccine 001, PGV 001, personalized peptide vaccine

Personalized Genome Vaccine 001

Poly-ICLC DRUG

Each subject will receive ten additional (10) total doses of the Poly-ICLC. The additional Poly-ICLC dose will be administered on study visit: v5, v7, v9, v11, v13, v15, v17, v19, v21 and v23.

Also known as: Hiltonol®

Personalized Genome Vaccine 001

Lenalidomide DRUG

10mg once daily oral dose for maintenance therapy in multiple myeloma patients.

Personalized Genome Vaccine 001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must have a histologically or cytological-proven diagnosis of one of the following malignancies:
• Oral, oropharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma
• Non-small cell carcinoma of the bronchus and/or lung
• Ductal or lobular carcinoma of the breast
• Serous carcinoma of the ovary, fallopian tube, or other uterine adnexa
• Urothelial cell carcinoma of renal pelvis, ureter, or bladder
• Cutaneous squamous cell carcinoma
• All epithelial carcinoma of the ovary, fallopian tube, or other uterine adnexa
• The subject must be medically capable of providing the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor.
• a. This requirement may be satisfied by providing an archival tissue sample in the form of a formalin-fixed paraffin-embedded or frozen tissue block from an earlier resection.
• The subject must have no measurable disease at the time of investigational product administration.
• The subject must complete all prior surgery requiring general anesthesia at least four (4) weeks before administration of the investigational product. The subject must complete all surgery requiring local/epidural anesthesia at least seventy-two (72) hours prior to administration of the investigational product.
• The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product.
• The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product. The subject must complete all prior focal radiation therapy at least two (2) weeks prior to the administration of the investigational agent. The subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product.
• The subject may continue hormonal therapy (i.e tamoxifen, anastrozole) during the study.

You may not qualify if:

• The subject has metastatic disease at the time of screening.
• The subject has a history of unrelated neoplastic disease, which has been deemed active within thirty-six (36) months of the screening evaluation, with the exception of the following:
• Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or squamous cell carcinoma.
• In female subjects: High-grade or low-grade squamous intraepithelial lesions or equivalent cervical lesions
• In male subjects: tumors of the prostate with a combined Gleason Score ≤ 7
• The subject has a prior history of unrelated neoplastic disease, and has received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.
• The subject has a history of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), Chronic hepatitis B or hepatitis C or is otherwise reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression.
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions.
• The subject has a history of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of:
• a. Vitiligo
• The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product.
• The subject has a history of serious allergic reaction to any substance, resulting in hospitalization or requiring other emergent medical attention.
• The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness.
• The subject has been diagnosed and treated at an external facility, and the resulting tissue specimen is of insufficient quality such that it precludes clinical sequencing or any other necessary study procedure, and the subject is unwilling to undergo an additional biopsy procedure.
• The subject is less than eighteen (18) years of age, or otherwise unable to give informed consent due to minor status.

Sponsors & Collaborators

• Nina Bhardwaj: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Peptides; poly ICLC; Lenalidomide

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nina Bhardwaj, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Immunotherapy Program

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 28, 2016
• Study Start: April 1, 2016
• Primary Completion: November 12, 2019
• Study Completion: June 8, 2020
• Last Updated: January 11, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)