Clinical Trials /

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

NCT02126579

Description:

The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

Title

  • Brief Title: Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
  • Official Title: Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
  • Clinical Trial IDs

    NCT ID: NCT02126579

    ORG ID: 15931

    NCI ID: MEL60

    Trial Conditions

    Melanoma

    Metastatic Melanoma

    Mucosal Melanoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    The purpose of this study is to learn what effects (good and bad) an experimental vaccine
    (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide
    ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine
    and these drugs cause any changes in your immune system.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A Experimental Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
    Arm B Experimental Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
    Arm C Experimental Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after the vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
    Arm D Experimental Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
    Arm E Experimental Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
    Arm F Experimental Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
    Arm G Experimental Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically or cytologically proven Stage IIB - IV melanoma rendered clinically
    free of disease by surgery, other therapy, or spontaneous remission within 6 months
    prior to registration.

    - Patients may have had melanoma from a cutaneous, mucosal or unknown primary site

    - Patients with small radiologic or clinical findings may be eligible

    - Patients with treated brain metastases may be eligible if the following are true:

    - Total number of brain metastases ever is less than or equal to 3

    - The brain metastases have been completely removed by surgery or have been
    treated completely with stereotactic radiotherapy

    - There has been no evident growth of any brain metastases since treatment

    - No treated brain metastases is greater than 2 cm at the time of protocol entry

    - Patients must have at least 1 intact axillary and/or inguinal lymph node basin

    - ECOG performance status of 0-1

    - Lab parameters as follows:

    - HLA-A1, A2, A3, B35, or B51

    - ANC > 1000/mm3 and Platelets > 100,000/mm3 and Hemoglobin > 9 g/dL

    - AST and ALT up to 2.5 x ULN

    - Bilirubin up to 2.5 x ULN

    - Alkaline Phosphatase up to 2.5 x ULN

    - Creatinine up to 1.5 x ULN

    - HGBA1C level < 7%

    Exclusion Criteria:

    - Patients with melanoma from a uveal or ocular primary site

    - Patients currently receiving any systemic therapy within 4 weeks of study
    registration. Gamma knife or stereotactic radiosurgery must not be administered
    within 1 week prior to study registration. Patients who are currently receiving
    nitrosoureas within the preceding 6 weeks.

    - Patients who have received CTLA-4, PD-1, PD-L1, CD137, or CD27 within the prior 12
    months.

    - Patients with known or suspected allergy to any component of the vaccine

    - HIV positive or active Hepatitis C virus

    - Patients receiving any of the following medications within 4 weeks are excluded:

    - Agents with immunomodulating activity (with the exception of non-steroidal
    anti-inflammatory agents and topical steroids)

    - Allergy desensitization injections

    - Systemic corticosteroids, administered parenterally or orally. Inhaled steroids
    (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are
    acceptable including steroids with very low solubility administered nasally for
    local effects only (e.g. Nasonex)

    - Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).

    - Interferon therapy

    - Interleukin-2 or other interleukins

    - Other investigational drugs or investigational therapy if currently receiving or have
    received within 1 month

    - Pregnancy or the possibility of becoming pregnant during the study. And women who are
    breastfeeding.

    - Must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive
    therapy, or autoimmune disorders with visceral involvement. The following are not
    exclusionary:

    - Presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer)
    without symptoms

    - Clinical evidence of vitiligo

    - Other forms of depigmenting illness

    - Mild arthritis requiring NSAID medications

    - Patients with a medical contradiction or potential problem with complying with the
    protocol, in the opinion of the investigator

    - Patients with Class III or IV heart disease (according to NYHA classification)

    - Patients with a body weight < 110 lbs.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of adverse events per study arm

    T cell response in peripheral blood over duration of study participation

    Secondary Outcome Measures

    T cell response and function in peripheral blood

    Trial Keywords

    melanoma

    neoplasms

    Poly ICLC

    Freund's Adjuvant

    Metastatic melanoma

    resiquimod

    adjuvants

    peptide vaccine