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

Primary Purpose

Melanoma, Metastatic Melanoma, Mucosal Melanoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peptide Vaccine (LPV7) + Tetanus peptide
PolyICLC
Resiquimod
IFA
Sponsored by
Craig L Slingluff, Jr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring melanoma, neoplasms, Poly ICLC, Freund's Adjuvant, Metastatic melanoma, resiquimod, adjuvants, peptide vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MDAnderson Cancer Center
  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A (Part 1)

Arm B (Part 1)

Arm C (Part 1)

Arm D (Part 1)

Arm E (Part 1)

Arm F (Part 1)

Arm G(Part 1)

Arm E2

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of adverse events per study arm
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
- Levels of peptide-reactive CD8+ T cells in the peripheral blood

Secondary Outcome Measures

T cell response and function in peripheral blood
CD4+ T cell responses to peptides in the vaccine, and their function

Full Information

First Posted
April 24, 2014
Last Updated
November 15, 2020
Sponsor
Craig L Slingluff, Jr
Collaborators
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02126579
Brief Title
Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
Acronym
MEL60
Official Title
Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Craig L Slingluff, Jr
Collaborators
University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Metastatic Melanoma, Mucosal Melanoma
Keywords
melanoma, neoplasms, Poly ICLC, Freund's Adjuvant, Metastatic melanoma, resiquimod, adjuvants, peptide vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Part 1)
Arm Type
Experimental
Arm Description
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 Title
Arm B (Part 1)
Arm Type
Experimental
Arm Description
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 Title
Arm C (Part 1)
Arm Type
Experimental
Arm Description
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 Title
Arm D (Part 1)
Arm Type
Experimental
Arm Description
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 Title
Arm E (Part 1)
Arm Type
Experimental
Arm Description
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 Title
Arm F (Part 1)
Arm Type
Experimental
Arm Description
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 Title
Arm G(Part 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm E2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Peptide Vaccine (LPV7) + Tetanus peptide
Intervention Description
1.5 mL administered half intradermally and half subcutaneously.
Intervention Type
Other
Intervention Name(s)
PolyICLC
Intervention Description
1 mL administered half intradermally and half subcutaneously
Intervention Type
Other
Intervention Name(s)
Resiquimod
Intervention Description
500 mg applied to vaccine site after vaccine administration
Intervention Type
Other
Intervention Name(s)
IFA
Intervention Description
2 mL administered half intradermally and half subcutaneously
Primary Outcome Measure Information:
Title
Number of adverse events per study arm
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.
Time Frame
6 months
Title
T cell response in peripheral blood over duration of study participation
Description
- Levels of peptide-reactive CD8+ T cells in the peripheral blood
Time Frame
6 months
Secondary Outcome Measure Information:
Title
T cell response and function in peripheral blood
Description
CD4+ T cell responses to peptides in the vaccine, and their function
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig L Slingluff, Jr., M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
MDAnderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34413169
Citation
Patel SP, Petroni GR, Roszik J, Olson WC, Wages NA, Chianese-Bullock KA, Smolkin M, Varhegyi N, Gaughan E, Smith KT, Haden K, Hall EH, Gnjatic S, Hwu P, Slingluff CL. Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma. J Immunother Cancer. 2021 Aug;9(8):e003220. doi: 10.1136/jitc-2021-003220.
Results Reference
derived
Links:
URL
http://www.cancer.gov/cancertopics/types/melanoma
Description
NCI website

Learn more about this trial

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

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