Evidence map›Paper›PMID 34413169›Full record

Trial reportJournal for immunotherapy of cancer2021

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.

Sapna P Patel, Gina R Petroni, Jason Roszik, Walter C Olson, Nolan A Wages, Kimberly A Chianese-Bullock, Mark Smolkin, Nikole Varhegyi, Elizabeth Gaughan, Kelly T Smith and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02126579 (Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma.), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
3.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02126579 phase1 / phase2completednot on this map

Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)

TypeinterventionalSponsorCraig L Slingluff, JrRan2014 to 2021Enrolled50ConditionsMelanoma, Metastatic Melanoma, Mucosal MelanomaArmsPeptide Vaccine (LPV7) + Tetanus peptide, PolyICLC, Resiquimod, IFA
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 60 citations in OpenAlex.

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  20. Harnessing innate immune pathways for therapeutic advancement in cancer.Signal transduction and targeted therapy · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 1 country.

Sapna P PatelThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0003-1339-1517
Gina R PetroniUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Jason RoszikThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Walter C OlsonUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Nolan A WagesPublic Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Kimberly A Chianese-BullockUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Mark SmolkinPublic Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Nikole VarhegyiPublic Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Elizabeth GaughanUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Kelly T SmithUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Kathleen HadenUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Emily H HallUniversity of Virginia School of Medicine, Charlottesville, Virginia, USA.
Sacha GnjaticIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Patrick HwuMoffitt Cancer Center, Tampa, Florida, USA.
Craig L SlingluffDepartment of Surgery, University of Virginia, Charlottesville, Virginia, USA CLS8H@hscmail.mcc.virginia.edu.ORCID 0000-0002-6664-4373
University of Virginia · USThe University of Texas MD Anderson Cancer Center · USIcahn School of Medicine at Mount Sinai · USMoffitt Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Women's Oncology Program - WONP30CA044579 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Jay William FOX · 1987 to 2026
$72.1M
High-Dimensional Immune Monitoring of NCI-Supported Immunotherapy TrialsU24CA224319 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Sacha Gnjatic, Seunghee Kim-Schulze · 2017 to 2026
$21.5M
NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA044579NCI NIH HHS U24 CA224319
6 · The paper itself

Abstract

backgroundWe performed a clinical trial to evaluate safety and immunogenicity of a novel long peptide vaccine administered in combinations of incomplete Freund's adjuvant (IFA) and agonists for TLR3 (polyICLC) and TLR7/8 (resiquimod). We hypothesized that T cell responses to minimal epitope peptides (MEPs) within the long peptides would be enhanced compared with prior vaccines with MEP themselves and that T cell responses would be enhanced with TLR agonists, compared with IFA alone.

methodsParticipants with resected stage IIB-IV melanoma were vaccinated with seven long melanoma peptides (LPV7) from tyrosinase, gp100, MAGE-A1, MAGE-A10, and NY-ESO-1, each containing a known MEP for CD8

resultsFifty eligible participants were assigned to seven study groups, with highest enrollment on arm E (LPV7+Tet+IFA+polyICLC). There was one dose-limiting toxicity (DLT) in Group E (grade 3 injection site reaction, 6% DLT rate). All other treatment-related adverse events were grades 1-2. The CD8

conclusionsThe LPV7 vaccine is safe with each of seven adjuvant strategies and induced T cell responses to CD8 MEPs ex vivo in a subset of patients but did not enhance IRRs compared with prior vaccines using short peptides. Immunogenicity was supported more by IFA than by TLR agonists alone and may be enhanced by polyICLC plus IFA. TRIAL REGISTRATION NUMBER: NCT02126579.

Indexed as

FemaleHumansMaleMelanomaRisk FactorsToll-Like ReceptorsVaccines, SubunitToll-Like ReceptorsVaccines, Subunitadjuvantsimmunogenicityimmunologicmelanomavaccinationvaccine

Identifiers

PMID34413169
PMCPMC8378357
OpenAlexW3195791228

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.