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Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists (MEL60)

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ClinicalTrials.gov Identifier: NCT02126579
Recruitment Status : Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE April 30, 2014
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE May 1, 2014
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
  • Number of adverse events per study arm [ Time Frame: 6 months ]
    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.
  • T cell response in peripheral blood over duration of study participation [ Time Frame: 6 months ]
    - Levels of peptide-reactive CD8+ T cells in the peripheral blood
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02126579 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
T cell response and function in peripheral blood [ Time Frame: 6 months ]
CD4+ T cell responses to peptides in the vaccine, and their function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
Official Title  ICMJE Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Metastatic Melanoma
  • Mucosal Melanoma
Intervention  ICMJE
  • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    1.5 mL administered half intradermally and half subcutaneously.
  • Other: PolyICLC
    1 mL administered half intradermally and half subcutaneously
  • Other: Resiquimod
    500 mg applied to vaccine site after vaccine administration
  • Other: IFA
    2 mL administered half intradermally and half subcutaneously
Study Arms  ICMJE
  • Experimental: Arm A (Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: IFA
  • Experimental: Arm B (Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: PolyICLC
  • Experimental: Arm C (Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: Resiquimod
  • Experimental: Arm D (Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: PolyICLC
    • Other: Resiquimod
  • Experimental: Arm E (Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: PolyICLC
    • Other: IFA
  • Experimental: Arm F (Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: Resiquimod
    • Other: IFA
  • Experimental: Arm G(Part 1)

    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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: PolyICLC
    • Other: Resiquimod
    • Other: IFA
  • Experimental: Arm E2

    Peptide 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.

    Interventions:
    • Biological: Peptide Vaccine (LPV7) + Tetanus peptide
    • Other: PolyICLC
    • Other: IFA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2014)
58
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02126579
Other Study ID Numbers  ICMJE 15931
MEL60 ( Other Identifier: UVA Human Immune Therapy Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Craig L Slingluff, Jr, University of Virginia
Study Sponsor  ICMJE Craig L Slingluff, Jr
Collaborators  ICMJE University of Virginia
Investigators  ICMJE
Principal Investigator: Craig L Slingluff, Jr., M.D. University of Virginia
PRS Account University of Virginia
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP