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; Massimiliano Petrini; Anna Maria Granato; Elena Pancisi; Flavia Foca; Monia Dall’Agata; Isabella Bondi; Elena Amadori; Pietro Cortesi; Chiara Zani; Valentina Ancarani; Alessandro Gamboni; Antonio Polselli; Giuseppe Pasini; Daniela Bartolini; Giuseppe Maimone; Donatella Arpa; Luigino Tosatto

doi:10.3389/fimmu.2024.1404861

Frontiers in Immunology (Aug 2024)

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,
Massimiliano Petrini,
Anna Maria Granato,
Elena Pancisi,
Flavia Foca,
Monia Dall’Agata,
Isabella Bondi,
Elena Amadori,
Pietro Cortesi,
Chiara Zani,
Valentina Ancarani,
Alessandro Gamboni,
Antonio Polselli,
Giuseppe Pasini,
Daniela Bartolini,
Giuseppe Maimone,
Donatella Arpa,
Luigino Tosatto

Affiliations

Laura Ridolfi: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Lorena Gurrieri: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Nada Riva: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Jenny Bulgarelli: Experimental 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 Rosa: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Massimo Guidoboni: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Valentina Fausti: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Nicoletta Ranallo: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Sebastiano Calpona: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Marcella Tazzari: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Massimiliano Petrini: Experimental 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 Granato: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Elena Pancisi: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Flavia Foca: Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” Meldola, Meldola, Italy
Monia Dall’Agata: Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” Meldola, Meldola, Italy
Isabella Bondi: Unit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” Meldola, Meldola, Italy
Elena Amadori: Radiology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” Meldola, Meldola, Italy
Pietro Cortesi: Cardioncology Division, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Chiara Zani: Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Valentina Ancarani: Experimental and Clinical Oncology of Immunotherapy and Rare Cancers, Biobank Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy
Alessandro Gamboni: Department of Oncology and Hematology AUSL Romagna, Lugo, Italy
Antonio Polselli: Oncology Department Cattolica Hospital, Cattolica, Italy
Giuseppe Pasini: Oncology Department Rimini Hospital, Rimini, Italy
Daniela Bartolini: Pathology Unit, “Maurizio Bufalini” Hospital, Cesena, Italy
Giuseppe Maimone: 0Neurosurgery Unit Maurizio Bufalini Hospital, Cesena, Italy
Donatella Arpa: 1Radiotherapy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy
Luigino Tosatto: 0Neurosurgery Unit Maurizio Bufalini Hospital, Cesena, Italy

DOI: https://doi.org/10.3389/fimmu.2024.1404861
Journal volume & issue: Vol. 15

Abstract

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BackgroundGlioblastoma (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 lymphocytesMethodsThis 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 in vitro and in vivo (DTH skin test).ResultsBy 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.ConclusionsThis 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)

Published in Frontiers in Immunology

ISSN: 1664-3224 (Online)
Publisher: Frontiers Media S.A.
Country of publisher: Switzerland
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Immunologic diseases. Allergy
Website: http://journal.frontiersin.org/journal/immunology

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