Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
NCT ID: NCT02126579
Last Updated: 2024-02-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2014-05-01
2021-05-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Multi-phosphopeptide Vaccine Plus PolyICLC in Participants With High Risk and Advanced Malignancies
NCT01846143
Evaluation of the Immunogenicity of Vaccination With Multiple Synthetic Melanoma Peptides With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With Advanced Melanoma
NCT00938223
Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma
NCT00977145
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
NCT02425306
Vaccine Therapy in Treating Patients With Advanced Melanoma
NCT00705640
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
IFA
2 mL administered half intradermally and half subcutaneously
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
PolyICLC
1 mL administered half intradermally and half subcutaneously
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
Resiquimod
500 mg applied to vaccine site after vaccine administration
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
PolyICLC
1 mL administered half intradermally and half subcutaneously
Resiquimod
500 mg applied to vaccine site after vaccine administration
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
PolyICLC
1 mL administered half intradermally and half subcutaneously
IFA
2 mL administered half intradermally and half subcutaneously
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 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
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
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
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.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
PolyICLC
1 mL administered half intradermally and half subcutaneously
IFA
2 mL administered half intradermally and half subcutaneously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Virginia
OTHER
Craig L Slingluff, Jr
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Craig L Slingluff, Jr
Professor, Department of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Craig L Slingluff, Jr., M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MDAnderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEL60
Identifier Type: OTHER
Identifier Source: secondary_id
15931
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.