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Endometrial CancerPhase 2DECENDONCT04212377

Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients

A Phase 2 study testing Dendritic Cells for endometrial cancer in people with Endometrial Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prevention of infectious diseases through immunization is one of the greatest achievements of modern medicine. Nonetheless, considerable challenges remain for improving the efficacy of existing vaccines for therapeutic immunizations for diseases such as cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Dendritic Cells for endometrial cancer
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteNetherlands
Study dates
8 Apr 2019to 9 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • women ≥ 18 years old with histologically confirmed stage IV or metastatic carcinoma of the endometrium of the endometroid, serous or carcinosarcoma type.
  • Hormone receptor negative or
  • resistant to hormonal therapy
  • ineligible for hormonal therapy because of other reasons
  • eligible for treatment with carboplatin paclitaxel combination chemotherapy
  • Life expectancy ≥ 6 months
Show all 18Show fewer
  • WHO/ECOG performance status 0-1 (Karnofsky index 100-70)
  • WBC >2.0 -109/l, neutrophils >1.5-109/L lymphocytes >0.8-109/L, platelets >100-109/L, hemoglobin >5,6 mmol/L (9.0 g/dL), serum creatinine <150 µmol/L, AST/ALT <3 x ULN, serum bilirubin <1.5 x ULN (exception: Gilbert's syndrome is permitted)
  • Expression of survivin and/or muc1 on tumor material
  • Expected adequacy of follow-up
  • Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1
  • Postmenopausal is defined as:
  • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments;
  • Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50,
  • radiation-induced oophorectomy with last menses >1 year ago,
  • chemotherapy-induced menopause with >1 year interval since last menses
  • or surgical sterilisation (bilateral oophorectomy or hysterectomy).
  • Written informed consent

Who cannot join

  • Uncontrolled hypercalcemia
  • History of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma
  • Known allergy to shell fish
  • Heart failure (NYHA class III/IV)
  • Serious active infections
  • Active hepatitis B, C or HIV infection
Show all 14Show fewer
  • Active syphilis infection
  • Autoimmune diseases (exception: vitiligo is permitted)
  • Organ allografts
  • An uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation
  • Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent
  • Any serious clinical condition that may interfere with the safe administration of DC vaccinations
  • Unable to undergo a tumor biopsy
  • Pregnancy or insufficient anti-conception if reproduction is still possible

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Radboud University Medical Center

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

Official title: An Exploratory Study: Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients

Prevention of infectious diseases through immunization is one of the greatest achievements of modern medicine. Nonetheless, considerable challenges remain for improving the efficacy of existing vaccines for therapeutic immunizations for diseases such as cancer. The investigators were amongst the first groups worldwide that introduced tumor antigen-loaded dendritic cell (DC)-based vaccines in the clinic1-3. Effective immune responses and favorable clinical outcomes have indeed been observed4-7. Thus far, mainly conventional in vitro generated monocyte-derived DCs (moDC) have been used in clinical trials worldwide. In the past 14 years the investigators have treated more than 375 patients and proven that DC therapy is feasible and non-toxic. The investigators observed that long lasting tumor specific T cell-mediated immunological responses are clearly linked to increased progression free survival as well as overall survival8.

In conclusion, based on all these observations the investigators are convinced that pDC and myDC employ different, and probably more optimal mechanisms to combat cancer. In addition, based on in vitro data and preclinical studies that suggest that blood pDC and myDC act synergistically, the investigators hypothesize that the combination of myDC and pDC may induce stronger anti-tumor immune responses as compared to pDC or myDC alone, or moDC.

Read the detailed description

Dendritic cell vaccination Prevention of infectious diseases through immunization is one of the greatest achievements of modern medicine. Nonetheless, considerable challenges remain for improving the efficacy of existing vaccines for therapeutic immunizations for diseases such as cancer. The investigators were amongst the first groups worldwide that introduced tumor antigen-loaded dendritic cell (DC)-based vaccines in the clinic1-3. Effective immune responses and favorable clinical outcomes have indeed been observed4-7. Thus far, mainly conventional in vitro generated monocyte-derived DCs (moDC) have been used in clinical trials worldwide. In the past 14 years the investigators have treated more than 375 patients and proven that DC therapy is feasible and non-toxic. The investigators observed that long lasting tumor specific T cell-mediated immunological responses are clearly linked to increased progression free survival as well as overall survival8.

However, moDC may not be the optimal source of DCs for DC vaccination studies, due to extensive culture periods and compounds required to obtain mature moDC. Peripheral blood-derived DC (plasmacytoid dendritic cells (pDC) and myeloid dendritic cells (myDC)) are possibly a better alternative since they do not require extensive culture periods. The investigators recently completed a clinical trial in stage IV melanoma patients using plasmacytoid pDC. The results on both immunological outcome as well as clinical outcome are promising. These freshly isolated natural pDC prolonged median overall survival to 22 months in comparison to 7.6 months in matched historical melanoma patients who had received standard chemotherapy9. In patients receiving moDC-vaccinations, the investigators did not observe such a clear increase in overall survival, suggesting that pDC-vaccines may induce even more potent anti-tumor responses than moDC-vaccines. In terms of immunological outcome transcription of both interferon-alpha (IFN-α) and interferon-beta (IFN-β) genes was clearly induced 4 hours after vaccination and decreased 20 hours later. An IFN gene signature is known to be highly important for eradication of viruses. This signature is indicative for a temporal systemic induction of type I IFNs. Type I IFN might also stimulate myDC and enhance their ability to cross-prime CD8+ T cells, thereby inducing more efficient anti-tumor T cell responses when compared with in vitro generated DC. This is supported by studies in mice: type I IFN were critical for the induction of anti-tumor immune responses10,11. In the 14 stage IV melanoma patients included in our myDC trial the investigators observed already in 3 patients highly functional tumour-specific T-cells in peripheral blood and in DTH sites coinciding with tumour regression12. For comparison: in the investigators trials with monocyte-derived DC, less bonafide T cell responses were seen after DC vaccination, suggesting that blood myDC induce more potent immune responses compared to monocyte-derived DC.

In conclusion, based on all these observations the investigators are convinced that pDC and myDC employ different, and probably more optimal mechanisms to combat cancer. In addition, based on in vitro data and preclinical studies that suggest that blood pDC and myDC act synergistically, the investigators hypothesize that the combination of myDC and pDC may induce stronger anti-tumor immune responses as compared to pDC or myDC alone, or moDC.

Immunotherapy in endometrial cancer Endometrial cancer is the only gynaecologic malignancy with a rising incidence and mortality. While cure is routinely achieved with surgery alone or in combination with adjuvant pelvic radiotherapy when disease is confined to the uterus, patients with metastatic or recurrent disease exhibit limited response rates to cytotoxic chemotherapy, targeted agents, or hormonal therapy. Some figures: at the time of diagnosis, 67% of women have disease confined to the uterus and an associated 5-year survival rate of 95%. In contrast, the 8% of patients with distant metastases at the time of diagnosis have a 5-year survival rate of 17% and face the prospect of cytotoxic chemotherapy (primarily with taxanes, platinum and anthracyclines).

Given the unmet clinical need in this patient population, exploration of novel therapeutic approaches is warranted, and attention is turning to immunomodulation. Existing evidence suggests that endometrial cancer is sufficiently immunogenic to be a reasonable candidate for immunotherapy.

Dendritic cell vaccination after chemotherapy Tumors exploit several mechanisms to suppress anti-tumor immune responses, including the recruitment of suppressive cells, such as myeloid-derived suppressor cells (MDSCs), into the tumor microenvironment13. The presence of MDSCs in the suppressive tumor microenvironment is correlated with decreased efficacy of several immunotherapies, including DC vaccination and ipilimumab14,15. Data obtained in the investigators lab indicates that MDSCs can be targeted with platinum-based chemotherapeutics. In head-and-neck squamous cell carcinoma patients treated with six weekly dosages of cisplatin, the frequency as well as suppressive capacity of MDSCs were significantly inhibited two weeks after the last dose. Treating the patients with DC vaccination after six cycles of chemotherapy with carboplatin, might therefore have a positive impact on the clinical outcome of DC vaccination.

Antigen loading of dendritic cells To be effective as an antigen-presenting cell, the MHC molecules of a DC must be loaded with antigenic cargo. The investigators selected well-defined common tumor antigens in the form of long peptides of two tumor associated antigens frequently shared by endometrial cancer, survivin and MUC1. This DC antigen-loading strategy allows accurate monitoring of the ensuing immunity against the defined peptides.

Being tested
Dendritic Cells for endometrial cancer
Keywords
Endometrial Cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dendritic Cells for endometrial cancerBiological

    Our study population consists of 8 mEC patients who receive carboplatin / paclitaxel chemotherapy in a weekly schedule on weeks 1, 2, 3 and weeks 5,6 and 7. In week 8, myeloid and plasmacytoid DC (nDC) are loaded with tumor lysate and MUC1 and survivin PepTivators, injected intranodally. An extensive immuno-motoring will be performed on all patients. Patients who show stable disease, partial response, or full response continue with extended three-week chemotherapy regimens with intranodal injections of nDC at weeks 17, 20, and 23.

Study groups in NCT04212377
Study groupRoleWhat they receive
exploratoryExperimentalsingle arm exploratory, single-centre study
Receives: Biological: Dendritic Cells for endometrial cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunologic efficacy of tumor-peptide loaded nDC in mEC patients

    Immunomonitoring including: a) functional response and tetramer analysis of DTH infiltrating lymphocytes against tumor peptides

    Measured: 1 year

Secondary outcomes (2)
  1. toxicity: Adverse Events

    Toxicity will be assessed according to the Common Terminology Criteria for Adverse Events version 4.0

    Measured: study start till week 26

  2. Health- related Quality of Life

    Health-related quality of life, assessed using a composite of the European Organisation of Research and Treatment of Cancer (EORTC) core quality of life questionaire (QLQ C-30) of life will be assessed by the general EORTC-QLQ C30

    Measured: Baseline, week 15 and week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2019
  2. Study start8 Apr 2019
  3. Primary completion9 Mar 2021
  4. Study completion9 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a single arm exploratory, single-centre study
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04212377
Sponsor's protocol ID
NL68332.000.18
Acronym
DECENDO
Status last verified
Dec 2020
First submitted
20 Nov 2019
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Figdor CG, de Vries IJ, Lesterhuis WJ, Melief CJ. Dendritic cell immunotherapy: mapping the way. Nat Med. 2004 May;10(5):475-80. doi: 10.1038/nm1039.

    PubMed 15122249
  • Schuler G, Schuler-Thurner B, Steinman RM. The use of dendritic cells in cancer immunotherapy. Curr Opin Immunol. 2003 Apr;15(2):138-47. doi: 10.1016/s0952-7915(03)00015-3.

    PubMed 12633662
  • Steinman RM, Banchereau J. Taking dendritic cells into medicine. Nature. 2007 Sep 27;449(7161):419-26. doi: 10.1038/nature06175.

    PubMed 17898760
  • de Vries IJ, Bernsen MR, Lesterhuis WJ, Scharenborg NM, Strijk SP, Gerritsen MJ, Ruiter DJ, Figdor CG, Punt CJ, Adema GJ. Immunomonitoring tumor-specific T cells in delayed-type hypersensitivity skin biopsies after dendritic cell vaccination correlates with clinical outcome. J Clin Oncol. 2005 Aug 20;23(24):5779-87. doi: 10.1200/JCO.2005.06.478.

    PubMed 16110035
  • Lodge PA, Jones LA, Bader RA, Murphy GP, Salgaller ML. Dendritic cell-based immunotherapy of prostate cancer: immune monitoring of a phase II clinical trial. Cancer Res. 2000 Feb 15;60(4):829-33.

    PubMed 10706088
  • Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.

    PubMed 20818862
  • Huber ML, Haynes L, Parker C, Iversen P. Interdisciplinary critique of sipuleucel-T as immunotherapy in castration-resistant prostate cancer. J Natl Cancer Inst. 2012 Feb 22;104(4):273-9. doi: 10.1093/jnci/djr514. Epub 2012 Jan 9.

    PubMed 22232132
  • Aarntzen EH, Bol K, Schreibelt G, Jacobs JF, Lesterhuis WJ, Van Rossum MM, Adema GJ, Figdor CG, Punt CJ, De Vries IJ. Skin-test infiltrating lymphocytes early predict clinical outcome of dendritic cell-based vaccination in metastatic melanoma. Cancer Res. 2012 Dec 1;72(23):6102-10. doi: 10.1158/0008-5472.CAN-12-2479. Epub 2012 Sep 24.

    PubMed 23010076
  • Tel J, Aarntzen EH, Baba T, Schreibelt G, Schulte BM, Benitez-Ribas D, Boerman OC, Croockewit S, Oyen WJ, van Rossum M, Winkels G, Coulie PG, Punt CJ, Figdor CG, de Vries IJ. Natural human plasmacytoid dendritic cells induce antigen-specific T-cell responses in melanoma patients. Cancer Res. 2013 Feb 1;73(3):1063-75. doi: 10.1158/0008-5472.CAN-12-2583. Epub 2013 Jan 23.

    PubMed 23345163
  • Choi C, Witzens M, Bucur M, Feuerer M, Sommerfeldt N, Trojan A, Ho A, Schirrmacher V, Goldschmidt H, Beckhove P. Enrichment of functional CD8 memory T cells specific for MUC1 in bone marrow of patients with multiple myeloma. Blood. 2005 Mar 1;105(5):2132-4. doi: 10.1182/blood-2004-01-0366. Epub 2004 Nov 23.

    PubMed 15561890
  • Fuertes MB, Kacha AK, Kline J, Woo SR, Kranz DM, Murphy KM, Gajewski TF. Host type I IFN signals are required for antitumor CD8+ T cell responses through CD8alpha+ dendritic cells. J Exp Med. 2011 Sep 26;208(10):2005-16. doi: 10.1084/jem.20101159. Epub 2011 Sep 19.

    PubMed 21930765
  • Schreibelt G, Bol KF, Westdorp H, Wimmers F, Aarntzen EH, Duiveman-de Boer T, van de Rakt MW, Scharenborg NM, de Boer AJ, Pots JM, Olde Nordkamp MA, van Oorschot TG, Tel J, Winkels G, Petry K, Blokx WA, van Rossum MM, Welzen ME, Mus RD, Croockewit SA, Koornstra RH, Jacobs JF, Kelderman S, Blank CU, Gerritsen WR, Punt CJ, Figdor CG, de Vries IJ. Effective Clinical Responses in Metastatic Melanoma Patients after Vaccination with Primary Myeloid Dendritic Cells. Clin Cancer Res. 2016 May 1;22(9):2155-66. doi: 10.1158/1078-0432.CCR-15-2205. Epub 2015 Dec 28.

    PubMed 26712687
  • de Haas N, de Koning C, Spilgies L, de Vries IJ, Hato SV. Improving cancer immunotherapy by targeting the STATe of MDSCs. Oncoimmunology. 2016 Jun 27;5(7):e1196312. doi: 10.1080/2162402X.2016.1196312. eCollection 2016 Jul.

    PubMed 27622051
  • Laborde RR, Lin Y, Gustafson MP, Bulur PA, Dietz AB. Cancer Vaccines in the World of Immune Suppressive Monocytes (CD14(+)HLA-DR(lo/neg) Cells): The Gateway to Improved Responses. Front Immunol. 2014 Apr 4;5:147. doi: 10.3389/fimmu.2014.00147. eCollection 2014.

    PubMed 24772111
  • Meyer C, Cagnon L, Costa-Nunes CM, Baumgaertner P, Montandon N, Leyvraz L, Michielin O, Romano E, Speiser DE. Frequencies of circulating MDSC correlate with clinical outcome of melanoma patients treated with ipilimumab. Cancer Immunol Immunother. 2014 Mar;63(3):247-57. doi: 10.1007/s00262-013-1508-5. Epub 2013 Dec 20.

    PubMed 24357148

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dendritic Cells for endometrial cancer in people with Endometrial Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunologic efficacy of tumor-peptide loaded nDC in mEC patients (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04212377, which also lists 76 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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