Clinical Trials /

Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies

NCT02721043

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Breast Invasive Ductal Carcinoma
  • Fallopian Tube Carcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Hypopharyngeal Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Lobular Breast Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Oral Cavity Carcinoma
  • Oropharyngeal Carcinoma
  • Ovarian Carcinoma
  • Ovarian Serous Adenocarcinoma
  • Primary Peritoneal Carcinoma
  • Renal Pelvis Carcinoma
  • Skin Squamous Cell Carcinoma
  • Ureter Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies
  • Official Title: Study Of Pgv001 A Multi-Peptide Therapeutic Vaccine Platform For Use In The Treatment Of Malignancies In The Adjuvant Setting

Clinical Trial IDs

  • ORG STUDY ID: GCO 15-1811
  • NCT ID: NCT02721043

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
PeptidesPersonalized Genome Vaccine 001, PGV 001, personalized peptide vaccinePersonalized Genome Vaccine 001
Poly-ICLCHiltonol®Personalized Genome Vaccine 001
LenalidomidePersonalized Genome Vaccine 001

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Personalized Genome Vaccine 001ExperimentalPGV-001 (peptides + Poly-ICLC) Peptides: 100mcg per peptide per dose. Poly-ICLC (Hiltonol®, Oncovir): 1.4mg (0.7mL, 2mg/mL)
  • Peptides
  • Poly-ICLC
  • Lenalidomide

Eligibility Criteria

        Inclusion Criteria:

          -  The subject must have a histologically or cytological-proven diagnosis of one of the
             following malignancies:

               1. Oral, oropharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma

               2. Non-small cell carcinoma of the bronchus and/or lung

               3. Ductal or lobular carcinoma of the breast

               4. Serous carcinoma of the ovary, fallopian tube, or other uterine adnexa

               5. Urothelial cell carcinoma of renal pelvis, ureter, or bladder

               6. Cutaneous squamous cell carcinoma

               7. 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.

               1. 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.

               2. 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.

               3. 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.

               4. The subject may continue hormonal therapy (i.e tamoxifen, anastrozole) during the
                  study.

          -  The risk of disease recurrence with a five (5) year time period, as estimated by the
             treating physician, must be greater than or equal thirty percent (30%).

          -  The subject must have a life expectancy greater than twelve (12) months at the time of
             screening.

          -  The subject must have a performance status of 0-1 as determined by criteria set
             forward by the Eastern Cooperative Oncology Group.

          -  The subject must have at the time of screening acceptable hematologic, hepatic, and
             renal function, defined by the following:

               1. Absolute neutrophil count ≥ 1000/mm3

               2. Platelet count ≥ 50,000/mm3,

               3. Creatinine ≤ 2.5 mg/dL,

               4. Total bilirubin ≤ 1.5 mg/dL,

               5. Transaminases ≤ 2 times above the upper limits of the institutional normal.

               6. INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an
                  INR>2 may be enrolled at the discretion of the investigator if they have not had
                  any episodes of severe hemorrhage.

          -  The subject must be 18 years of age or older.

          -  The subject must be deemed competent to give informed consent.

          -  The subject must agree to use two effective forms of contraception beginning at least
             four (4) weeks prior to study entry, and continuing to do so for the duration of their
             participation in the study.

        Exclusion Criteria:

          -  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:

               1. Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or
                  squamous cell carcinoma.

               2. In female subjects: High-grade or low-grade squamous intraepithelial lesions or
                  equivalent cervical lesions

               3. 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.

          -  The subject is a prisoner, as defined by [45 CFR 46.303(c)].

          -  The subject is cognitively impaired, and unable to give informed consent.

          -  The subject is pregnant, as defined by a presumptive sign of pregnancy such as missed
             menses or a positive pregnancy test [45 CFR 46.203(b)].

        Note: The effects of the investigational product on the developing human fetus are unknown.
        Female subjects of childbearing potential are required to have a negative qualitative serum
        pregnancy test at the time of enrollment and within twenty-four (24) hours prior to the
        first dose of the investigational product.

          1. Female subject of childbearing potential is defined as follows:

               1. Subject with regular menses

               2. Subject with amenorrhea, irregular cycles, or using a contraceptive method that
                  precludes withdrawal bleeding

               3. Subject with history of tubal ligation

          2. Female subject not of childbearing potential is defined as follows:

               1. Subject who has undergone hysterectomy and/or bilateral oophorectomy.

               2. Subject who is post-menopausal, which is defined as amenorrhea for at least one
                  (1) year in a female subject who is greater than forty-five (>45) years old.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicities (DLT)
Time Frame:up to day 42
Safety Issue:
Description: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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Nina Bhardwaj

Trial Keywords

  • Personalized vaccine
  • Poly-ICLC
  • Immunotherapy
  • Cancer

Last Updated