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

Melanoma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126579
• Other study ID #: 15931
• Secondary ID: MEL60
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 1, 2014
• Est. completion date: May 5, 2021

Study information

• Verified date: February 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 5, 2021
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma
• Mucosal Melanoma

Intervention

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
• Resiquimod
500 mg applied to vaccine site after vaccine administration
• IFA
2 mL administered half intradermally and half subcutaneously

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	MDAnderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Craig L Slingluff, Jr	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	T Cell Response and Function in Peripheral Blood	CD4+ T cell responses to peptides in the vaccine, and their function	6 months

External Links

•   NCI website