Evidence map›Paper›PMID 40251644›Full record

Trial reportJournal of translational medicine2025

Adjuvant dendritic cell-based immunotherapy in melanoma: insights into immune cell dynamics and clinical evidence from a phase II trial.

Jenny Bulgarelli, Claudia Piccinini, Emanuela Scarpi, Giorgia Gentili, Laura Renzi, Silvia Carloni, Francesco Limarzi, Elena Pancisi, Anna Maria Granato, Massimiliano Petrini and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02718391 (Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02718391 phase2terminatednot on this map

Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients: a Phase II Randomized Trial (ACDC Adjuvant Trial)

TypeinterventionalSponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSRan2015 to 2019Enrolled12ConditionsMalignant Melanoma, Adjuvant Drug Therapy, Vaccin TherapyArmsAutologous Dendritic Cell vaccine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Cellular immunotherapy in melanoma: the next frontier in cancer treatment.Journal of experimental & clinical cancer research : CR · 2026
    Review
  2. Article
  3. Review
  4. 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

26 authors.

Jenny BulgarelliAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Claudia PiccininiAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy. claudia.piccinini@irst.emr.it.ORCID 0000-0001-5862-6207
Emanuela ScarpiUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Giorgia GentiliUnit of Biostatistics and Clinical Trials, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Laura RenziMedical Genetics Unit, AUSL Romagna, 47522, Cesena, Italy.
Silvia CarloniAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Francesco LimarziPathology Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, 47121, Forlì, Italy.
Elena PancisiAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Anna Maria GranatoAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Massimiliano PetriniAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Francesco De RosaAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Massimo GuidoboniDepartment of Oncology, University Hospital of Ferrara, 44124, Ferrara, Italy.
Dalila FanelliAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Maria Maddalena TumedeiAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Marcella TazzariAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Stefano BaravelliUnit of Immunohematology and Transfusion Medicine, Morgagni-Pierantoni Hospital, AUSL Romagna, 47121, Forlì, Italy.
Ilaria BronicoRadiotherapy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Pietro CortesiCardio-Oncology Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Sara PignattaAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Laura CapelliBioscience Laboratory, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" (IRST), 47014, Meldola, Italy.
Valentina AncaraniAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Giovanni FoschiAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Livia TurciAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.
Francesca TauceriAdvanced Oncological Surgery Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, 47121, Forlì, Italy.
Massimo FramariniAdvanced Oncological Surgery Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, 47121, Forlì, Italy.
Laura RidolfiAdvanced Cellular Therapies and Rare Tumors Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", 47014, Meldola, Italy.

Funding

Ministero della Salute PNC-E3-2022-23683269 PNC-LSH-TA
6 · The paper itself

Abstract

backgroundDendritic cells (DCs) are the most efficient antigen-presenting cells and play a central role in the immune system, orchestrating immune response against tumors. We previously demonstrated that DC-based vaccination effectively induces anti-tumor immunity, yet at the same time showing a robust safety profile, making this treatment a potential candidate for effective adjuvant immunotherapy. To explore this possibility, we designed a randomized phase II trial (EudraCT no. 2014-005123-27) to provide a complementary autologous DC vaccination to patients (pts) with resected stage III/IV melanoma.

methodsOverall, a total of 18 eligible pts were included in this study, 10 of whom received 6 monthly DC vaccination cycles combined with IL-2 administration (arm A), and 8 pts were enrolled in the follow-up observational cohort (arm B). A deep immune biomarkers profiling by multiplex immunoassay, human leukocyte antigens (HLA) typing, multiparametric flow cytometry and in situ tumor microenvironment analysis was performed for the entire pts cohort. The immunological response was assessed in vivo by DTH test and ex vivo against selected melanoma-associated antigens applying the IFN-γ ELISPOT assay.

resultsPts receiving DC vaccination showed a better relapse-free survival compared to the observational cohort (median 6.6 months, 95% CI, 2.3-not reached (nr) (arm A) vs 5.2 months, 95% CI, 2.5-nr (arm B), not significant), with a favorable trends for female pts (median 15.5 months, 95% CI, 2.6-nr (female) vs 3.3, 95% CI, 2.3-nr (male)), pts with less than 60 years (median 22.5 months, 95% CI, 2.6-nr (age < 60) vs 4.7 months, 95% CI, 2.3-nr (age ≥ 60), and pts with wild-type BRAF status (median 22.5 months, 95% CI, 8.6-nr (BRAF wt) vs 3.8 months, 95% CI, 2.3-nr (BRAF mutated). The toxicity profile was favourable, with no severe adverse events and only mild, manageable reactions. Moreover, additional immune response data suggested increased immune modulation in vaccinated patients, which may reflect a shift in immune dynamics.

conclusionsOur findings support the safety and tolerability of DC vaccination as an adjuvant treatment for melanoma, demonstrating significant immune modulation at both the tumor site and peripherally in relapsed and non-relapsed patients. These results highlight the potential of autologous, personalised DC-based therapies and pave the way for the development of innovative immunotherapy combinations in future treatment strategies. Trial registration ClinicalTrials.gov NCT02718391; EudraCT no. 2014-005123-27.

Indexed as

Adjuvants, ImmunologicDendritic CellsImmunotherapyMelanomaAdultAgedCancer VaccinesDisease-Free SurvivalFemaleHumansMaleMiddle AgedTumor MicroenvironmentAdjuvants, ImmunologicCancer VaccinesDendritic cellImmune modulatoryImmunotherapySkin cancerTumor microenvironment

Identifiers

PMID40251644
PMCPMC12007200

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.