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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

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.

Condition or disease Intervention/treatment Phase
Melanoma Metastatic Melanoma Mucosal Melanoma Biological: Peptide Vaccine (LPV7) + Tetanus peptide Other: PolyICLC Other: Resiquimod Other: IFA Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
Actual Study Start Date : May 1, 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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.

Biological: Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.

Other: IFA
2 mL administered half intradermally and half subcutaneously

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.

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

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.

Biological: Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.

Other: Resiquimod
500 mg applied to vaccine site after vaccine administration

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.

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

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.

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: IFA
2 mL administered half intradermally and half subcutaneously

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.

Biological: Peptide Vaccine (LPV7) + Tetanus peptide
1.5 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

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.

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

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.

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: IFA
2 mL administered half intradermally and half subcutaneously




Primary Outcome Measures :
  1. 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.


  2. 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


Secondary Outcome Measures :
  1. T cell response and function in peripheral blood [ Time Frame: 6 months ]
    CD4+ T cell responses to peptides in the vaccine, and their function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126579


Locations
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United States, Texas
MDAnderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Craig L Slingluff, Jr
University of Virginia
Investigators
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Principal Investigator: Craig L Slingluff, Jr., M.D. University of Virginia

Additional Information:
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Responsible Party: Craig L Slingluff, Jr, Professor, Department of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT02126579     History of Changes
Other Study ID Numbers: 15931
MEL60 ( Other Identifier: UVA Human Immune Therapy Center )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Keywords provided by Craig L Slingluff, Jr, University of Virginia:
melanoma
neoplasms
Poly ICLC
Freund's Adjuvant
Metastatic melanoma
resiquimod
adjuvants
peptide vaccine
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Poly ICLC
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers