Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
28 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-03
Study Completion Date
2025-03-09
Brief Summary
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In this multicenter phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline treatment of malignant pleural mesothelioma (MPM). The general objective is to provide the first-in-human experimental demonstration that the combination of platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction of both systemic and in situ mesothelioma-specific immune responses in patients with MPM.
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Detailed Description
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Malignant pleural mesothelioma (MPM) is a highly aggressive and in virtually all cases fatal cancer that is tightly associated with prior asbestos exposure. Despite some improvement over time, the prognosis of patient diagnosed with MPM remains dismal with a median overall survival from diagnosis of only 12 months.
In this single arm phase I/II trial the investigators want to demonstrate the feasibility and safety of WT1-targeted dendritic cell vaccination in MPM patients as frontline treatment in conjunction with first line platinum/pemetrexed-based chemotherapy and the induction of both systemic and in situ mesothelioma-specific immune responses. During three years of recruitment the investigators aim at including 20 patients diagnosed with histologically proven epithelial MPM (WHO grade 0-1) who are able to undergo leukapheresis, chemotherapy, immunotherapy and pleurectomy/decortication (P/D; in case of resectable disease). Patients who underwent prior treatment for MPM or with a history of another malignancy within the last five years will be excluded.
The intention of this study is to administer four vaccine doses in combination with standard of care of four 3-weekly cytoreductive platinum/pemetrexed-based chemotherapy cycles to each participant and prior to surgery (P/D) in the case of resectable MPM. Patients will receive four 3-weekly intradermal vaccinations with autologous WT1 messenger (m)RNA-loaded dendritic cells (V1-4), at day 14 after the start of each chemotherapy cycle (CT1-4).
The dendritic cell therapy product will be generated and administered in the Antwerp University Hospital, more specifically the Center for Cell Therapy and Regenerative Medicine (CCRG) and the Division of Hematology, both headed by Prof. Zwi Berneman.
The DC vaccines will be under embargo from release until the safety and quality control test results have become available and all release criteria have been met. A detailed overview of all applicable release criteria is provided in the investigational medicinal product dossier. The embargo period generally lasts 3 weeks counting from the day of cryopreservation (i.e. 8 days after leukapheresis).
Recruitment started in August 2017. Study-related follow-up of the included patients is intended to be until 90 days after final DC vaccine administration or 22 months after diagnosis, whichever occurs later. In addition to feasibility and safety of the chemoimmunotherapy schedule, the investigators will look for the time to progression (TTP), progression-free survival (PFS), overall survival (OS), systemic immunogenicity and local immunogenicity.
In this single arm phase I/II trial the investigators want to demonstrate the feasibility and safety of WT1-targeted dendritic cell vaccination in MPM patients as frontline treatment in conjunction with first line platinum/pemetrexed-based chemotherapy and the induction of both systemic and in situ mesothelioma-specific immune responses. During three years of recruitment the investigators aim at including 20 patients diagnosed with histologically proven epithelial MPM (WHO grade 0-1) who are able to undergo leukapheresis, chemotherapy, immunotherapy and pleurectomy/decortication (P/D; in case of resectable disease). Patients who underwent prior treatment for MPM or with a history of another malignancy within the last five years will be excluded.
The intention of this study is to administer four vaccine doses in combination with standard of care of four 3-weekly cytoreductive platinum/pemetrexed-based chemotherapy cycles to each participant and prior to surgery (P/D) in the case of resectable MPM. Patients will receive four 3-weekly intradermal vaccinations with autologous WT1 messenger (m)RNA-loaded dendritic cells (V1-4), at day 14 after the start of each chemotherapy cycle (CT1-4).
The dendritic cell therapy product will be generated and administered in the Antwerp University Hospital, more specifically the Center for Cell Therapy and Regenerative Medicine (CCRG) and the Division of Hematology, both headed by Prof. Zwi Berneman.
The DC vaccines will be under embargo from release until the safety and quality control test results have become available and all release criteria have been met. A detailed overview of all applicable release criteria is provided in the investigational medicinal product dossier. The embargo period generally lasts 3 weeks counting from the day of cryopreservation (i.e. 8 days after leukapheresis).
Recruitment started in August 2017. Study-related follow-up of the included patients is intended to be until 90 days after final DC vaccine administration or 22 months after diagnosis, whichever occurs later. In addition to feasibility and safety of the chemoimmunotherapy schedule, the investigators will look for the time to progression (TTP), progression-free survival (PFS), overall survival (OS), systemic immunogenicity and local immunogenicity.
Conditions
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Malignant Pleural Mesothelioma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Single Arm
dendritic cell vaccination plus chemotherapy
Group Type
EXPERIMENTAL
dendritic cell vaccination plus chemotherapy
Intervention Type
BIOLOGICAL
A. Chemoimmunotherapy:
1. four 3-weekly cycles of platinum/pemetrexed; on day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as intravenous (IV) infusion over 10 minutes followed 30 minutes later by cisplatin 75 mg/m2 as IV over approximately 2 hours.
2. four intradermal vaccinations with 8-10 x 10e6 autologous WT1 mRNA-loaded DCs; at day 14+/- 3 days after the start of each chemotherapy cycle.
B. Surgery: pleurectomy/decortication; in case of resectable disease, 4-6 weeks after start of the last chemotherapy cycle.
Interventions
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dendritic cell vaccination plus chemotherapy
A. Chemoimmunotherapy:
1. four 3-weekly cycles of platinum/pemetrexed; on day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as intravenous (IV) infusion over 10 minutes followed 30 minutes later by cisplatin 75 mg/m2 as IV over approximately 2 hours.
2. four intradermal vaccinations with 8-10 x 10e6 autologous WT1 mRNA-loaded DCs; at day 14+/- 3 days after the start of each chemotherapy cycle.
B. Surgery: pleurectomy/decortication; in case of resectable disease, 4-6 weeks after start of the last chemotherapy cycle.
Intervention Type
BIOLOGICAL
Other Intervention Names
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chemoimmunotherapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis with histologically proven epithelial
* Aged ≥ 18 years at the time of enrollment
* WHO performance status 0-1 at the time of enrollment
* Fit to undergo general anesthesia, a thoracoscopy, leukapheresis, chemotherapy, immunotherapy and P/D (in case of resectable disease)
* No history of receiving any investigational treatment within 28 days of study enrollment
* No history of intolerance to pemetrexed and/or cisplatin
* Women of child bearing potential must have negative serum or urine pregnancy test at the time of screening. They should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least hundred days after the last study treatment. If pregnancy does occur within this time period, the Principal investigator must be informed as soon as possible. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until hundred days after the last study treatment
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discusses with the patient before registration in the trial. Absence of any other inability or unwillingness to comply with the requirements of the protocol as assessed by the investigator
* Before patient registration written informed consent must be given according to ICH/GCP, and national/local regulations
* Aged ≥ 18 years at the time of enrollment
* WHO performance status 0-1 at the time of enrollment
* Fit to undergo general anesthesia, a thoracoscopy, leukapheresis, chemotherapy, immunotherapy and P/D (in case of resectable disease)
* No history of receiving any investigational treatment within 28 days of study enrollment
* No history of intolerance to pemetrexed and/or cisplatin
* Women of child bearing potential must have negative serum or urine pregnancy test at the time of screening. They should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least hundred days after the last study treatment. If pregnancy does occur within this time period, the Principal investigator must be informed as soon as possible. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until hundred days after the last study treatment
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discusses with the patient before registration in the trial. Absence of any other inability or unwillingness to comply with the requirements of the protocol as assessed by the investigator
* Before patient registration written informed consent must be given according to ICH/GCP, and national/local regulations
Exclusion Criteria
* Unwilling or unable to comply with the study requirements
* Prior treatment for MPM
* History of another malignancy within the last five years (except for carcinoma in situ of the cervix, basal cell or spinocellular carcinoma of the skin or unless the investigator rationalizes otherwise)
* Known proven metastases
* Known concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
* Pregnant or breast-feeding
* Prior treatment for MPM
* History of another malignancy within the last five years (except for carcinoma in situ of the cervix, basal cell or spinocellular carcinoma of the skin or unless the investigator rationalizes otherwise)
* Known proven metastases
* Known concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
* Pregnant or breast-feeding
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Kom Op Tegen Kanker
OTHER
Sponsor Role
collaborator
Stichting tegen Kanker
OTHER
Sponsor Role
collaborator
University Hospital, Antwerp
OTHER
Sponsor Role
lead
Responsible Party
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Zwi Berneman
Study coordinator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Zwi N Berneman, MD, PhD
Role: STUDY_DIRECTOR
Antwerp University Hospital, Division of Hematology and Center for Cell Therapy and Regenerative Medicine
Eva Lion, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Antwerp, Laboratory of Experimental Hematology
Evelien LJ Smits, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Antwerp, Laboratory of Experimental Hematology
Sébastien Anguille, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Antwerp University Hospital, Division of Hematology
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Site Status
AZ Middelares
Ghent, , Belgium
Site Status
AZ Nikolaas
Sint-Niklaas, , Belgium
Site Status
Countries
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Belgium
References
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Robinson BW, Musk AW, Lake RA. Malignant mesothelioma. Lancet. 2005 Jul 30-Aug 5;366(9483):397-408. doi: 10.1016/S0140-6736(05)67025-0.
Reference Type
BACKGROUND
Robinson BW, Lake RA. Advances in malignant mesothelioma. N Engl J Med. 2005 Oct 13;353(15):1591-603. doi: 10.1056/NEJMra050152. No abstract available.
Reference Type
BACKGROUND
Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136.
Reference Type
BACKGROUND
Musk AW, Olsen N, Alfonso H, Reid A, Mina R, Franklin P, Sleith J, Hammond N, Threlfall T, Shilkin KB, de Klerk NH. Predicting survival in malignant mesothelioma. Eur Respir J. 2011 Dec;38(6):1420-4. doi: 10.1183/09031936.00000811. Epub 2011 Jul 7.
Reference Type
BACKGROUND
Bagia M, Nowak AK. Novel targeted therapies and vaccination strategies for mesothelioma. Curr Treat Options Oncol. 2011 Jun;12(2):149-62. doi: 10.1007/s11864-011-0149-1.
Reference Type
BACKGROUND
Bograd AJ, Suzuki K, Vertes E, Colovos C, Morales EA, Sadelain M, Adusumilli PS. Immune responses and immunotherapeutic interventions in malignant pleural mesothelioma. Cancer Immunol Immunother. 2011 Nov;60(11):1509-27. doi: 10.1007/s00262-011-1103-6. Epub 2011 Sep 13.
Reference Type
BACKGROUND
Izzi V, Masuelli L, Tresoldi I, Foti C, Modesti A, Bei R. Immunity and malignant mesothelioma: from mesothelial cell damage to tumor development and immune response-based therapies. Cancer Lett. 2012 Sep 1;322(1):18-34. doi: 10.1016/j.canlet.2012.02.034. Epub 2012 Mar 3.
Reference Type
BACKGROUND
Gregoire M. What's the place of immunotherapy in malignant mesothelioma treatments? Cell Adh Migr. 2010 Jan-Mar;4(1):153-61. doi: 10.4161/cam.4.1.11361. Epub 2010 Jan 30.
Reference Type
BACKGROUND
Kushitani K, Takeshima Y, Amatya VJ, Furonaka O, Sakatani A, Inai K. Immunohistochemical marker panels for distinguishing between epithelioid mesothelioma and lung adenocarcinoma. Pathol Int. 2007 Apr;57(4):190-9. doi: 10.1111/j.1440-1827.2007.02080.x.
Reference Type
BACKGROUND
Anguille S, Smits EL, Lion E, van Tendeloo VF, Berneman ZN. Clinical use of dendritic cells for cancer therapy. Lancet Oncol. 2014 Jun;15(7):e257-67. doi: 10.1016/S1470-2045(13)70585-0.
Reference Type
BACKGROUND
Hegmans JP, Hemmes A, Aerts JG, Hoogsteden HC, Lambrecht BN. Immunotherapy of murine malignant mesothelioma using tumor lysate-pulsed dendritic cells. Am J Respir Crit Care Med. 2005 May 15;171(10):1168-77. doi: 10.1164/rccm.200501-057OC. Epub 2005 Mar 11.
Reference Type
BACKGROUND
Hegmans JP, Veltman JD, Lambers ME, de Vries IJ, Figdor CG, Hendriks RW, Hoogsteden HC, Lambrecht BN, Aerts JG. Consolidative dendritic cell-based immunotherapy elicits cytotoxicity against malignant mesothelioma. Am J Respir Crit Care Med. 2010 Jun 15;181(12):1383-90. doi: 10.1164/rccm.200909-1465OC. Epub 2010 Feb 18.
Reference Type
BACKGROUND
Smits EL, Anguille S, Cools N, Berneman ZN, Van Tendeloo VF. Dendritic cell-based cancer gene therapy. Hum Gene Ther. 2009 Oct;20(10):1106-18. doi: 10.1089/hum.2009.145.
Reference Type
BACKGROUND
Van Tendeloo VF, Ponsaerts P, Lardon F, Nijs G, Lenjou M, Van Broeckhoven C, Van Bockstaele DR, Berneman ZN. Highly efficient gene delivery by mRNA electroporation in human hematopoietic cells: superiority to lipofection and passive pulsing of mRNA and to electroporation of plasmid cDNA for tumor antigen loading of dendritic cells. Blood. 2001 Jul 1;98(1):49-56. doi: 10.1182/blood.v98.1.49.
Reference Type
BACKGROUND
Van Tendeloo VF, Van de Velde A, Van Driessche A, Cools N, Anguille S, Ladell K, Gostick E, Vermeulen K, Pieters K, Nijs G, Stein B, Smits EL, Schroyens WA, Gadisseur AP, Vrelust I, Jorens PG, Goossens H, de Vries IJ, Price DA, Oji Y, Oka Y, Sugiyama H, Berneman ZN. Induction of complete and molecular remissions in acute myeloid leukemia by Wilms' tumor 1 antigen-targeted dendritic cell vaccination. Proc Natl Acad Sci U S A. 2010 Aug 3;107(31):13824-9. doi: 10.1073/pnas.1008051107. Epub 2010 Jul 14.
Reference Type
BACKGROUND
Benteyn D, Anguille S, Van Lint S, Heirman C, Van Nuffel AM, Corthals J, Ochsenreither S, Waelput W, Van Beneden K, Breckpot K, Van Tendeloo V, Thielemans K, Bonehill A. Design of an Optimized Wilms' Tumor 1 (WT1) mRNA Construct for Enhanced WT1 Expression and Improved Immunogenicity In Vitro and In Vivo. Mol Ther Nucleic Acids. 2013 Nov 19;2(11):e134. doi: 10.1038/mtna.2013.54.
Reference Type
BACKGROUND
Treasure T, Lang-Lazdunski L, Waller D, Bliss JM, Tan C, Entwisle J, Snee M, O'Brien M, Thomas G, Senan S, O'Byrne K, Kilburn LS, Spicer J, Landau D, Edwards J, Coombes G, Darlison L, Peto J; MARS trialists. Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol. 2011 Aug;12(8):763-72. doi: 10.1016/S1470-2045(11)70149-8. Epub 2011 Jun 30.
Reference Type
BACKGROUND
Lang-Lazdunski L, Bille A, Lal R, Cane P, McLean E, Landau D, Steele J, Spicer J. Pleurectomy/decortication is superior to extrapleural pneumonectomy in the multimodality management of patients with malignant pleural mesothelioma. J Thorac Oncol. 2012 Apr;7(4):737-43. doi: 10.1097/JTO.0b013e31824ab6c5.
Reference Type
BACKGROUND
McCoy MJ, Nowak AK, Lake RA. Chemoimmunotherapy: an emerging strategy for the treatment of malignant mesothelioma. Tissue Antigens. 2009 Jul;74(1):1-10. doi: 10.1111/j.1399-0039.2009.01275.x. Epub 2009 May 4.
Reference Type
BACKGROUND
Galluzzi L, Senovilla L, Zitvogel L, Kroemer G. The secret ally: immunostimulation by anticancer drugs. Nat Rev Drug Discov. 2012 Feb 3;11(3):215-33. doi: 10.1038/nrd3626.
Reference Type
BACKGROUND
Park S, Schalling M, Bernard A, Maheswaran S, Shipley GC, Roberts D, Fletcher J, Shipman R, Rheinwald J, Demetri G, et al. The Wilms tumour gene WT1 is expressed in murine mesoderm-derived tissues and mutated in a human mesothelioma. Nat Genet. 1993 Aug;4(4):415-20. doi: 10.1038/ng0893-415.
Reference Type
BACKGROUND
Cheever MA, Allison JP, Ferris AS, Finn OJ, Hastings BM, Hecht TT, Mellman I, Prindiville SA, Viner JL, Weiner LM, Matrisian LM. The prioritization of cancer antigens: a national cancer institute pilot project for the acceleration of translational research. Clin Cancer Res. 2009 Sep 1;15(17):5323-37. doi: 10.1158/1078-0432.CCR-09-0737.
Reference Type
BACKGROUND
Krug LM, Dao T, Brown AB, Maslak P, Travis W, Bekele S, Korontsvit T, Zakhaleva V, Wolchok J, Yuan J, Li H, Tyson L, Scheinberg DA. WT1 peptide vaccinations induce CD4 and CD8 T cell immune responses in patients with mesothelioma and non-small cell lung cancer. Cancer Immunol Immunother. 2010 Oct;59(10):1467-79. doi: 10.1007/s00262-010-0871-8. Epub 2010 Jun 8.
Reference Type
BACKGROUND
Van Driessche A, Berneman ZN, Van Tendeloo VF. Active specific immunotherapy targeting the Wilms' tumor protein 1 (WT1) for patients with hematological malignancies and solid tumors: lessons from early clinical trials. Oncologist. 2012;17(2):250-9. doi: 10.1634/theoncologist.2011-0240. Epub 2012 Jan 30.
Reference Type
BACKGROUND
Hsu FJ, Benike C, Fagnoni F, Liles TM, Czerwinski D, Taidi B, Engleman EG, Levy R. Vaccination of patients with B-cell lymphoma using autologous antigen-pulsed dendritic cells. Nat Med. 1996 Jan;2(1):52-8. doi: 10.1038/nm0196-52.
Reference Type
BACKGROUND
Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.
Reference Type
BACKGROUND
Hoos A. Evolution of end points for cancer immunotherapy trials. Ann Oncol. 2012 Sep;23 Suppl 8:viii47-52. doi: 10.1093/annonc/mds263.
Reference Type
BACKGROUND
Anguille S, Smits EL, Bryant C, Van Acker HH, Goossens H, Lion E, Fromm PD, Hart DN, Van Tendeloo VF, Berneman ZN. Dendritic Cells as Pharmacological Tools for Cancer Immunotherapy. Pharmacol Rev. 2015 Oct;67(4):731-53. doi: 10.1124/pr.114.009456.
Reference Type
BACKGROUND
Qi XW, Zhang F, Wu H, Liu JL, Zong BG, Xu C, Jiang J. Wilms' tumor 1 (WT1) expression and prognosis in solid cancer patients: a systematic review and meta-analysis. Sci Rep. 2015 Mar 9;5:8924. doi: 10.1038/srep08924.
Reference Type
BACKGROUND
Thomas A, Chen Y, Yu T, Gill A, Prasad V. Distinctive clinical characteristics of malignant mesothelioma in young patients. Oncotarget. 2015 Jun 30;6(18):16766-73. doi: 10.18632/oncotarget.4414.
Reference Type
BACKGROUND
Panou V, Vyberg M, Weinreich UM, Meristoudis C, Falkmer UG, Roe OD. The established and future biomarkers of malignant pleural mesothelioma. Cancer Treat Rev. 2015 Jun;41(6):486-95. doi: 10.1016/j.ctrv.2015.05.001. Epub 2015 May 8.
Reference Type
BACKGROUND
Nowak AK, Cook AM, McDonnell AM, Millward MJ, Creaney J, Francis RJ, Hasani A, Segal A, Musk AW, Turlach BA, McCoy MJ, Robinson BW, Lake RA. A phase 1b clinical trial of the CD40-activating antibody CP-870,893 in combination with cisplatin and pemetrexed in malignant pleural mesothelioma. Ann Oncol. 2015 Dec;26(12):2483-90. doi: 10.1093/annonc/mdv387. Epub 2015 Sep 18.
Reference Type
BACKGROUND
Marcq E, Pauwels P, van Meerbeeck JP, Smits EL. Targeting immune checkpoints: New opportunity for mesothelioma treatment? Cancer Treat Rev. 2015 Dec;41(10):914-24. doi: 10.1016/j.ctrv.2015.09.006. Epub 2015 Sep 28.
Reference Type
BACKGROUND
Fisher SA, Cleaver A, Lakhiani DD, Khong A, Connor T, Wylie B, Lesterhuis WJ, Robinson BW, Lake RA. Neoadjuvant anti-tumor vaccination prior to surgery enhances survival. J Transl Med. 2014 Sep 4;12:245. doi: 10.1186/s12967-014-0245-7.
Reference Type
BACKGROUND
Berneman ZN, Van de Velde AL, Willemen Y, Anguille S, Saevels K, Germonpré P, Huizing MT, Peeters M, Snoeckx A, Parizel P, Van Tendeloo VF, Lion E, Nijs G, Stein B, Vermeulen K, Maes MB, Malfait R, Vrelust I, Verlinden A, Gadisseur AP, Schroyens WA, Lammens M and Smits EL. Blood 124(21): 310-310, 2014.
Reference Type
BACKGROUND
Berneman Z, Germonpre P, Huizing MT, Van De Velde A, Nijs G, Stein B, Van Tendeloo V, Lion E, Smits EL and Anguille S. J Clin Oncol 32:5s(suppl): abstr 7583, 2014.
Reference Type
BACKGROUND
Adusumilli PS. Translational immunotherapeutics: chemoimmunotherapy for malignant pleural mesothelioma. Cancer. 2014 Nov 1;120(21):3268-71. doi: 10.1002/cncr.28883. Epub 2014 Jul 2. No abstract available.
Reference Type
BACKGROUND
Coosemans A, Vanderstraeten A, Tuyaerts S, Verschuere T, Moerman P, Berneman ZN, Vergote I, Amant F, VAN Gool SW. Wilms' Tumor Gene 1 (WT1)--loaded dendritic cell immunotherapy in patients with uterine tumors: a phase I/II clinical trial. Anticancer Res. 2013 Dec;33(12):5495-500.
Reference Type
BACKGROUND
Coosemans A, Vanderstraeten A, Tuyaerts S, Verschuere T, Moerman P, Berneman Z, Vergote I, Amant F, Van Gool SW. Immunological response after WT1 mRNA-loaded dendritic cell immunotherapy in ovarian carcinoma and carcinosarcoma. Anticancer Res. 2013 Sep;33(9):3855-9.
Reference Type
BACKGROUND
Willemen Y, Huizing MT, Smits E, Anguille S, Nijs G, Stein B, Van Tendeloo V, Peeters M, Berneman Z. J Clin Oncol 30(suppl): abstr e13051, 2012.
Reference Type
BACKGROUND
Anguille S, Van de Velde AL, Smits EL, Van Tendeloo VF, Juliusson G, Cools N, Nijs G, Stein B, Lion E, Van Driessche A, Vandenbosch I, Verlinden A, Gadisseur AP, Schroyens WA, Muylle L, Vermeulen K, Maes MB, Deiteren K, Malfait R, Gostick E, Lammens M, Couttenye MM, Jorens P, Goossens H, Price DA, Ladell K, Oka Y, Fujiki F, Oji Y, Sugiyama H, Berneman ZN. Dendritic cell vaccination as postremission treatment to prevent or delay relapse in acute myeloid leukemia. Blood. 2017 Oct 12;130(15):1713-1721. doi: 10.1182/blood-2017-04-780155. Epub 2017 Aug 22.
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BACKGROUND
Z. Berneman, A. Van de Velde, S. Anguille, Y. Willemen, M. Huizing, P. Germonpré, K. Saevels, G. Nijs, N. Cools, A. Van Driessche, B. Stein, H. De Reu, W. Schroyens, A. Gadisseur, A. Verlinden, K. Vermeulen, M. Maes, M. Lammens, H. Goossens, M. Peeters, V. Van Tendeloo, E. Smits. Vaccination with Wilms' Tumor Antigen (WT1) mRNA-Electroporated Dendritic Cells as an Adjuvant Treatment in 60 Cancer Patients: Report of Clinical Effects and Increased Survival in Acute Myeloid Leukemia, Metastatic Breast Cancer, Glioblastoma and Mesothelioma. Cytotherapy 2016, 18(6), p. S13-14
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BACKGROUND
Z. Berneman, S. Anguille, Y. Willemen, A. Van de Velde, P. Germonpré, M. Huizing, V. Van Tendeloo, K. Saevels, L. Rutsaert, K. Vermeulen, A. Snoeckx, B. Op de Beeck, N. Cools, G. Nijs, B. Stein, E. Lion, A. van Driessche, M. Peeters, E. Smits. Vaccination of cancer patients with dendritic cells electroporated with mRNA encoding the Wilms' Tumor protein (WT1): correlation of clinical effect and overall survival with T-cell response. Cytotherapy 2019, 21(5), p. S10.
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Other Identifiers
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CCRG13-002
Identifier Type: -
Identifier Source: org_study_id
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PHASE1
Single-step Antigen Loading and TLR Activation of Dendritic Cells in Melanoma Patients
NCT01530698
COMPLETED
PHASE1/PHASE2
Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients
NCT00243529
COMPLETED
PHASE1/PHASE2
Dendritic Cell Based Therapy of Malignant Melanoma
NCT00197912
COMPLETED
PHASE1/PHASE2
MIDRIXNEO-LUNG Dendritic Cell Vaccine in Patients With Non-small Cell Lung Cancer
NCT04078269
COMPLETED
PHASE1
DENdritic Cell Immunotherapy for Mesothelioma
NCT03610360
COMPLETED
PHASE2/PHASE3
Melanoma Patients Immunized with Natural DenDritic Cells
NCT02993315
COMPLETED
PHASE3
Dendritic Cell Vaccination in Patients With Advanced Melanoma
NCT03092453
COMPLETED
PHASE1
Trial of Vaccine Therapy With mRNA- Transfected Dendritic Cells in Patients With Advanced Malignant Melanoma
NCT01278940
COMPLETED
PHASE1/PHASE2
Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients
NCT00929019
TERMINATED
PHASE1/PHASE2
Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
NCT00243594
COMPLETED
PHASE1/PHASE2
Augmentation of Dendritic Cell-Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells in Stage IV Melanoma Patients
NCT00847106
COMPLETED
PHASE1/PHASE2
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
NCT00988312
COMPLETED
PHASE1
DC Vaccination in CML
NCT02543749
TERMINATED
PHASE1/PHASE2
Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma
NCT02248402
UNKNOWN
PHASE1/PHASE2
Immunotherapy of Melanoma With Tumor Antigen RNA and Small Inhibitory RNA Transfected Autologous Dendritic Cells
NCT00672542
COMPLETED
PHASE1
Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
NCT00978913
COMPLETED
PHASE1
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
NCT01875653
TERMINATED
PHASE3
Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma
NCT01983748
UNKNOWN
PHASE3
Dendritic Cell Based Therapy of Renal Cell Carcinoma
NCT00197860
COMPLETED
PHASE1/PHASE2
Toll-like Receptor (TLR) Ligand Matured Dendritic Cell Vaccination in Melanoma Patients
NCT00940004
COMPLETED
PHASE1/PHASE2
Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT03735589
WITHDRAWN
PHASE1/PHASE2
CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
NCT01995708
COMPLETED
PHASE1
Engineered Dendritic Cell Vaccines for Multiple Myeloma
NCT06435910
RECRUITING
PHASE1
Dendritic Cell Based Therapy of Metastatic Breast Cancer
NCT00197925
TERMINATED
PHASE1/PHASE2