Evidence map›Paper›PMID 39192978›Full record

Trial reportFrontiers in immunology2024

First step results from a phase II study of a dendritic cell vaccine in glioblastoma patients (CombiG-vax).

Laura Ridolfi, Lorena Gurrieri, Nada Riva, Jenny Bulgarelli, Francesco De Rosa, Massimo Guidoboni, Valentina Fausti, Nicoletta Ranallo, Sebastiano Calpona, Marcella Tazzari and 17 more

Erratum issuedAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Current Status and Evolution of Immunotherapy in Glioma Management.International journal of medical sciences · 2026
    Review
  9. Review
  10. Reduction of solid tumors by senescent cell immunization.Journal of translational medicine · 2025
    Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Laura RidolfiExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Lorena GurrieriExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Nada RivaExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Jenny BulgarelliExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Francesco De RosaExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Massimo GuidoboniExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Valentina FaustiExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Nicoletta RanalloExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Sebastiano CalponaExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Marcella TazzariExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Massimiliano PetriniExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Anna Maria GranatoExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Elena PancisiExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Flavia FocaUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola, Meldola, Italy.
Monia Dall'AgataUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola, Meldola, Italy.
Isabella BondiUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola, Meldola, Italy.
Elena AmadoriRadiology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" Meldola, Meldola, Italy.
Pietro CortesiCardioncology Division, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Chiara ZaniPharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Valentina AncaraniExperimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Alessandro GamboniDepartment of Oncology and Hematology AUSL Romagna, Lugo, Italy.
Antonio PolselliOncology Department Cattolica Hospital, Cattolica, Italy.
Giuseppe PasiniOncology Department Rimini Hospital, Rimini, Italy.
Daniela BartoliniPathology Unit, "Maurizio Bufalini" Hospital, Cesena, Italy.
Giuseppe MaimoneNeurosurgery Unit Maurizio Bufalini Hospital, Cesena, Italy.
Donatella ArpaRadiotherapy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
Luigino TosattoNeurosurgery Unit Maurizio Bufalini Hospital, Cesena, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Glioblastoma (GBM) is a poor prognosis grade 4 glioma. After surgical resection, the standard therapy consists of concurrent radiotherapy (RT) and temozolomide (TMZ) followed by TMZ alone. Our previous data on melanoma patients showed that Dendritic Cell vaccination (DCvax) could increase the amount of intratumoral-activated cytotoxic T lymphocytes. Methods: This is a single-arm, monocentric, phase II trial in two steps according to Simon's design. The trial aims to evaluate progression-free survival (PFS) at three months and the safety of a DCvax integrated with standard therapy in resected GBM patients. DCvax administration begins after completion of RT-CTwith weekly administrations for 4 weeks, then is alternated monthly with TMZ cycles. The primary endpoints are PFS at three months and safety. One of the secondary objectives is to evaluate the immune response both Results: By December 2022, the first pre-planned step of the study was concluded with the enrollment, treatment and follow up of 9 evaluable patients. Two patients had progressed within three months after leukapheresis, but none had experienced DCvax-related G3-4 toxicities Five patients experienced a positive DTH test towards KLH and one of these also towards autologous tumor homogenate. The median PFS from leukapheresis was 11.3 months and 12.2 months from surgery. Conclusions: This combination therapy is well-tolerated, and the two endpoints required for the first step have been achieved. Therefore, the study will proceed to enroll the remaining 19 patients. (Eudract number: 2020-003755-15 https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003755-15/IT).

Indexed as

Brain NeoplasmsCancer VaccinesDendritic CellsGlioblastomaAdultAgedFemaleHumansMaleMiddle AgedProgression-Free SurvivalTemozolomideCancer VaccinesTemozolomideadoptive cell therapydendritic cellglioblastomaimmunotherapyradiochemotherapyvaccine

Identifiers

PMID39192978
PMCPMC11347333

What OpenQuestion holds

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Registered trials

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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.