Evidence map›Paper›PMID 34992091›Full record

Trial reportJournal for immunotherapy of cancer2022

Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial.

Lukas Rob, David Cibula, Pawel Knapp, Peter Mallmann, Jaroslav Klat, Lubos Minar, Pavel Bartos, Josef Chovanec, Petr Valha, Marek Pluta and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02107937 (A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma), which is not on this map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT02107937 phase2completednot on this map

A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

TypeinterventionalSponsorSOTIO a.s.Ran2013 to 2021Enrolled136ConditionsOvarian Neoplasms, Ovarian Epithelial CancerArmsDCVAC/OvCa with Standard of Care, DCVAC/OvCa sequentially chemotherapy, Standard of Care
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 51 citations in OpenAlex.

  1. Review
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  3. DLK1: a novel therapeutic target in cancer.Endocrine-related cancer · 2026
    Review
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  15. Cancer vaccines: current status and future directions.Journal of hematology & oncology · 2025
    Review
  16. Review
  17. Review
  18. Chemotherapy Drives Tertiary Lymphoid Structures That Correlate with ICI-Responsive TCF1+CD8+ T Cells in Metastatic Ovarian Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  19. Cancer Vaccines: Recent Insights and Future Directions.International journal of molecular sciences · 2024
    Review
  20. 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

20 authors at 14 institutions in 3 countries.

Lukas RobThird Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
David CibulaFirst Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.ORCID 0000-0001-6387-9356
Pawel KnappDepartment of Gynaecologic Oncology, Medical University of Bialystok, Bialystok, Poland.
Peter MallmannUniversity Hospital of Cologne, Cologne, Germany.
Jaroslav KlatDepartment of Gynecology and Obstetrics, University Hospital Ostrava and University of Ostrava, Ostrava, Czech Republic.
Lubos MinarDepartment of Gynecology and Obstetrics, University Hospital Brno and Masaryk University, Brno, Czech Republic.
Pavel BartosDepartment of Gynecology and Obstetrics, Hospital Novy Jicin Novy Jicin, Novy Jicin, Czech Republic.
Josef ChovanecMasaryk Memorial Cancer Institute, Brno, Czech Republic.
Petr ValhaDepartment of Gynecology and Obstetrics, Hospital Ceske Budejovice, České Budějovice, Czech Republic.
Marek PlutaDepartment of Obstetrics and Gynecology, 2nd Faculty of Medicine, University Hospital Motol, Prague, Czech Republic.
Zdenek NovotnyDepartment of Gynecology and Obstetrics, Faculty Hospital Plzen, Plzen, Czech Republic.
Jiri SpacekDepartment of Obstetrics and Gynecology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic.
Bohuslav MelicharDepartment of Oncology, Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.
Dariusz KieszkoOncological Center of the Lublin Region, Lublin, Poland.
Jitka FucikovaDepartment of Immunology, Charles University, Praha, Czech Republic.ORCID 0000-0002-8423-479X
Tereza HrnciarovaFirst Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
Roman Pawel KorolkiewiczSOTIO a.s, Prague, Czech Republic.ORCID 0000-0002-9188-0327
Marek HraskaSOTIO a.s, Prague, Czech Republic spisek@sotio.com hraska@sotio.com.
Jirina BartunkovaSOTIO a.s, Prague, Czech Republic.
Radek SpisekSOTIO a.s, Prague, Czech Republic spisek@sotio.com hraska@sotio.com.
Charles University · CZSotio (Czechia) · CZLublin Oncology Center · PLMasaryk Memorial Cancer Institute · CZMasaryk University · CZMedical University of Białystok · PLMuzeum Novojičínska · CZNemocnice České Budějovice · CZPalacký University Olomouc · CZUniversity Hospital Cologne · DEUniversity Hospital Hradec Králové · CZUniversity Hospital in Motol · CZUniversity Hospital Plzen · CZUniversity of Ostrava · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost patients with epithelial ovarian cancer (EOC) relapse despite primary debulking surgery and chemotherapy (CT). Autologous dendritic cell immunotherapy (DCVAC) can present tumor antigens to elicit a durable immune response. We hypothesized that adding parallel or sequential DCVAC to CT stimulates antitumor immunity and improves clinical outcomes in patients with EOC. Based on the interim results of sequential DCVAC/OvCa administration and to accommodate the increased interest in maintenance treatment in EOC, the trial was amended by adding Part 2.

methodsPatients with International Federation of Gynecology and Obstetrics stage III EOC (serous, endometrioid, or mucinous), who underwent cytoreductive surgery up to 3 weeks prior to randomization and were scheduled for first-line platinum-based CT were eligible. Patients, stratified by tumor residuum (0 or <1 cm), were randomized (1:1:1) to DCVAC/OvCa parallel to CT (Group A), DCVAC/OvCa sequential to CT (Group B), or CT alone (Group C) in Part 1, and to Groups B and C in Part 2. Autologous dendritic cells for DCVAC were differentiated from patients' CD14

resultsBetween November 2013 and March 2016, 99 patients were randomized. The mITT (Part 1) comprised 31, 29, and 30 patients in Groups A, B, and C, respectively. Baseline characteristics and DCVAC/OvCa exposure were comparable across the treatment arms. DCVAC/OvCa showed a good safety profile with treatment-emergent adverse events related to DCVAC/OvCa in 2 of 34 patients (5.9%) in Group A and 2 of 53 patients (3.8%) in Group B. Median PFS was 20.3, not reached, and 21.4 months in Groups A, B, and C, respectively. The HR (95% CI) for Group A versus Group C was 0.98 (0.48 to 2.00; p=0.9483) and the HR for Group B versus Group C was 0.39 (0.16 to 0.96; p=0.0336). This was accompanied by a non-significant trend of improved OS in Groups A and B. Median OS was not reached in any group after a median follow-up of 66 months (34% of events).

conclusionsDCVAC/OvCa and leukapheresis was not associated with significant safety concerns in this trial. DCVAC/OvCa sequential to CT was associated with a statistically significant improvement in PFS in patients undergoing first-line treatment of EOC. TRIAL REGISTRATION NUMBER: NCT02107937, EudraCT2010-021462-30.

Indexed as

AcetylcysteineAdolescentAdultAgedAged, 80 and overAnimalsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Ovarian EpithelialDendritic CellsFemaleHumansImmunotherapyMiceMiddle AgedPaclitaxelAcetylcysteineCarboplatinPaclitaxelS-1,2-dichlorovinyl-N-acetylcysteineclinical trialsdendritic cellsimmunotherapyphase II as topic

Identifiers

PMID34992091
PMCPMC8739446
OpenAlexW4205437454

What OpenQuestion holds

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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.