Evidence map›Paper›PMID 34046035›Full record

Trial reportFrontiers in immunology2021

Combining a Universal Telomerase Based Cancer Vaccine With Ipilimumab in Patients With Metastatic Melanoma - Five-Year Follow Up of a Phase I/IIa Trial.

Elin Aamdal, Else Marit Inderberg, Espen Basmo Ellingsen, Wenche Rasch, Paal Fredrik Brunsvig, Steinar Aamdal, Karen-Marie Heintz, Daniel Vodák, Sigve Nakken, Eivind Hovig and 3 more

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

Trial report in Frontiers in immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02275416 (Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT02275416 phase1 / phase2completednot on this map

Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma

TypeinterventionalSponsorUltimovacs ASARan2015 to 2020Enrolled12ConditionsMalignant MelanomaArmsIpilimumab, UV1 vaccine, GM-CSF
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Amelanotic Melanoma-Biochemical and Molecular Induction Pathways.International journal of molecular sciences · 2024
    Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Immune checkpoint inhibitors and cancer immunotherapy by aptamers: an overview.Medical oncology (Northwood, London, England) · 2023
    Review
  20. Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Advanced Melanoma: Results from a Phase I Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
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

13 authors at 3 institutions in 1 country.

Elin AamdalDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Else Marit InderbergDepartment of Cellular Therapy, Oslo University Hospital, Oslo, Norway.
Espen Basmo EllingsenInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Wenche RaschUltimovacs Allmennaksjeselskap (ASA), Oslo, Norway.
Paal Fredrik BrunsvigDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Steinar AamdalDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Karen-Marie HeintzDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
Daniel VodákDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
Sigve NakkenDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
Eivind HovigDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
Marta NyakasDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Tormod Kyrre GurenDepartment of Oncology, Oslo University Hospital, Oslo, Norway.
Gustav GaudernackInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.
Oslo University Hospital · NOUniversity of Oslo · NOUltimovacs (Norway) · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Ipilimumab improves survival for patients with metastatic malignant melanoma. Combining a therapeutic cancer vaccine with ipilimumab may increase efficacy by providing enhanced anti-tumor immune responses. UV1 consists of three synthetic long peptides from human telomerase reverse transcriptase (hTERT). These peptides comprise epitopes recognized by T cells from cancer patients experiencing long-term survival following treatment with a first-generation hTERT vaccine, and generate long-lasting immune responses in cancer patients when used as monotherapy. The objective of this trial was to investigate the safety and efficacy of combining UV1 with ipilimumab in metastatic melanoma. Patients and Methods: In this phase I/IIa, single center trial [NCT02275416], patients with metastatic melanoma received repeated UV1 vaccinations, with GM-CSF as an adjuvant, in combination with ipilimumab. Patients were evaluated for safety, efficacy and immune response. Immune responses against vaccine peptides were monitored in peripheral blood by measuring antigen-specific proliferation and IFN-γ production. Results: Twelve patients were recruited. Adverse events were mainly diarrhea, injection site reaction, pruritus, rash, nausea and fatigue. Ten patients showed a Th1 immune response to UV1 peptides, occurring early and after few vaccinations. Three patients obtained a partial response and one patient a complete response. Overall survival was 50% at 5 years. Conclusion: Treatment was well tolerated. The rapid expansion of UV1-specific Th1 cells in the majority of patients indicates synergy between UV1 vaccine and CTLA-4 blockade. This may have translated into clinical benefit, encouraging the combination of UV1 vaccination with standard of care treatment regimes containing ipilimumab/CTLA-4 blocking antibodies.

Indexed as

AdultAgedBiomarkersBiopsyCancer VaccinesCombined Modality TherapyFemaleFollow-Up StudiesHumansIpilimumabMaleMelanomaMiddle AgedTelomeraseTreatment OutcomeBiomarkersCancer VaccinesIpilimumabTelomeraseUV1 vaccineipilimumabmelanomapeptide vaccine immunotherapyphase I/IIa studiestelomerase (hTERT)

Identifiers

PMID34046035
PMCPMC8147687
OpenAlexW3161047938

What OpenQuestion holds

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LicenceCC BY
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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.