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:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

  • ORG STUDY ID: 15931
  • SECONDARY ID: MEL60
  • NCT ID: NCT02126579

Conditions

  • Melanoma
  • Metastatic Melanoma
  • Mucosal Melanoma

Interventions

DrugSynonymsArms
Peptide Vaccine (LPV7) + Tetanus peptideArm A (Part 1)

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.

Trial Arms

NameTypeDescriptionInterventions
Arm A (Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm B (Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm C (Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm D (Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm E (Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm F (Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm G(Part 1)ExperimentalPeptide 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.
  • Peptide Vaccine (LPV7) + Tetanus peptide
Arm E2ExperimentalPeptide Vaccine (LPV7) + IFA + PolyICLC vaccines administered in one skin location. Each vaccine will be administered in the same skin site for all 6 vaccines. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
  • Peptide Vaccine (LPV7) + Tetanus peptide

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 ≤ 7.5%

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of adverse events per study arm
Time Frame:6 months
Safety Issue:
Description:Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.

Secondary Outcome Measures

Measure:T cell response and function in peripheral blood
Time Frame:6 months
Safety Issue:
Description:CD4+ T cell responses to peptides in the vaccine, and their function

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Craig L Slingluff, Jr

Trial Keywords

  • melanoma
  • neoplasms
  • Poly ICLC
  • Freund's Adjuvant
  • Metastatic melanoma
  • resiquimod
  • adjuvants
  • peptide vaccine

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