Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
MEL60
Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
2 other identifiers
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2014
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 30, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2021
CompletedResults Posted
Study results publicly available
November 3, 2023
CompletedFebruary 28, 2024
February 1, 2024
5.6 years
April 24, 2014
April 28, 2022
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Treatment-related 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.
6 months
T Cell Response in Peripheral Blood Over Duration of Study Participation
Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
6 months
Secondary Outcomes (1)
T Cell Response and Function in Peripheral Blood
6 months
Study Arms (8)
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.
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.
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.
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.
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.
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.
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.
Arm E2
EXPERIMENTALPeptide 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
1.5 mL administered half intradermally and half subcutaneously.
1 mL administered half intradermally and half subcutaneously
500 mg applied to vaccine site after vaccine administration
2 mL administered half intradermally and half subcutaneously
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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.
- Presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Craig L Slingluff, Jrlead
- University of Virginiacollaborator
Study Sites (2)
MDAnderson Cancer Center
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (1)
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.
PMID: 34413169DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Craig Slingluff, MD; Professor, Department of Surgery; Program Director, UVA Cancer Center
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Craig L Slingluff, Jr., M.D.
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Department of Surgery
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 30, 2014
Study Start
May 1, 2014
Primary Completion
November 20, 2019
Study Completion
May 5, 2021
Last Updated
February 28, 2024
Results First Posted
November 3, 2023
Record last verified: 2024-02