Evidence map›Paper›PMID 31699709›Full record

Trial reportCancer immunology research2020

Combined Vaccination with NY-ESO-1 Protein, Poly-ICLC, and Montanide Improves Humoral and Cellular Immune Responses in Patients with High-Risk Melanoma.

Anna Pavlick, Ana B Blazquez, Marcia Meseck, Michael Lattanzi, Patrick A Ott, Thomas U Marron, Rose Marie Holman, John Mandeli, Andres M Salazar, Christopher B McClain and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04672291 (A Phase I-Ib, Double-blinded, Randomized Repeated Dose Single Center, Safety and Immunogenicity Study of Nasal Poly-ICLC), which is not on this map. Cited by 53 papers.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed
2.8field-weighted citation impact, top 8% 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.

NCT04672291 phase1completednot on this mapstarted 2021, after this paper: background citation

A Phase I-Ib, Double-blinded, Randomized Repeated Dose Single Center, Safety and Immunogenicity Study of Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults

TypeinterventionalSponsorOncovir, Inc.Ran2021 to 2023Enrolled43ConditionsCOVID - 19ArmsPoly-ICLC (Hiltonol®) or Placebo
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 71 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Tim-3-targeted vaccines overcome tumor immunosuppression and reduce cDC1 dependence to elicit potent anti-tumor immunity.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  6. Review
  7. EngineeredMaterials today. Bio · 2025
    Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Dendritic cell maturation in cancer.Nature reviews. Cancer · 2025
    Review
  14. Nanoimmunotherapy: the smart trooper for cancer therapy.Exploration of targeted anti-tumor therapy · 2025
    Review
  15. Toll-like receptor agonists as cancer vaccine adjuvants.Human vaccines & immunotherapeutics · 2024
    Review
  16. Biomaterial-Based In Situ Cancer Vaccines.Advanced materials (Deerfield Beach, Fla.) · 2024
    Review
  17. NY-ESO-1 antigen: A promising frontier in cancer immunotherapy.Clinical and translational medicine · 2024
    Review
  18. Review
  19. Article
  20. Strategies for Overcoming Immune Evasion in Bladder Cancer.International journal of molecular sciences · 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 6 institutions in 1 country.

Anna Pavlick *Cancer Institute, New York University School of Medicine, New York, New York.
Ana B Blazquez *Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Marcia MeseckTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Michael LattanziCancer Institute, New York University School of Medicine, New York, New York.ORCID 0000-0002-6500-4753
Patrick A OttDana-Farber Cancer Institute, Boston, Massachusetts.
Thomas U MarronTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Rose Marie HolmanNew York University School of Medicine, New York, New York.
John MandeliIcahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, New York.
Andres M SalazarOncovir, Inc., Washington, D.C.
Christopher B McClainTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0002-8246-4639
Gustavo GimenezTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.
Sreekumar BalanTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0002-2092-5145
Sacha GnjaticTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0001-5643-9520
Rachel Lubong SabadoGenentech, San Francisco, California.
Nina BhardwajTisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York. nina.bhardwaj@mssm.edu.
Icahn School of Medicine at Mount Sinai · USNew York University · USTisch Hospital · USAcentech (United States) · USDana-Farber Cancer Institute · USLabCorp (United States) · US

Funding

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
NK cell exhaustion in metastatic melanomaR01CA201189 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BHARDWAJ, NINA · 2016 to 2020
$2.1M
Matrix metalloproteinase-2 modulates inflammation via TLR2R01CA180913 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI BHARDWAJ, NINA · 2014 to 2018
$1.8M
NCI NIH HHS R01 CA180913NCI NIH HHS R01 CA201189NCI NIH HHS U24 CA224319
6 · The paper itself

Abstract

Given its ability to induce both humoral and cellular immune responses, NY-ESO-1 has been considered a suitable antigen for a cancer vaccine. Despite promising results from early-phase clinical studies in patients with melanoma, NY-ESO-1 vaccine immunotherapy has not been widely investigated in larger trials; consequently, many questions remain as to the optimal vaccine formulation, predictive biomarkers, and sequencing and timing of vaccines in melanoma treatment. We conducted an adjuvant phase I/II clinical trial in high-risk resected melanoma to optimize the delivery of poly-ICLC, a TLR-3/MDA-5 agonist, as a component of vaccine formulation. A phase I dose-escalation part was undertaken to identify the MTD of poly-ICLC administered in combination with NY-ESO-1 and montanide. This was followed by a randomized phase II part investigating the MTD of poly-ICLC with NY-ESO-1 with or without montanide. The vaccine regimens were generally well tolerated, with no treatment-related grade 3/4 adverse events. Both regimens induced integrated NY-ESO-1-specific CD4

Indexed as

Adjuvants, ImmunologicAgedAntigens, NeoplasmCancer VaccinesCarboxymethylcellulose SodiumCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCross-PrimingFemaleHumansImmunity, CellularImmunity, HumoralInterferon InducersMaleMannitolMelanomaAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesCarboxymethylcellulose SodiumCTAG1B protein, humanInterferon InducersMannitolMembrane Proteinsmontanide ISA 51Oleic AcidsPoly I-Cpoly ICLCPolylysine

Identifiers

PMID31699709
PMCPMC6946846
OpenAlexW2985824393

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.