Autologous Dendritic Cell Vaccination in Mesothelioma

NCT02649829 | Completed Phase 1

• 1 other identifier: CCRG13-002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Malignant Pleural Mesothelioma

Keywords

dendritic cell vaccination; chemo-immunotherapy; Wilms' tumor 1 (WT1)

Outcome Measures

Primary Outcomes (2)

• Number of MPM patients with feasible and safe DC vaccine production

  Production of autologous DC vaccines from newly diagnosed MPM patients will be evaluated for: 1. Feasibility, assessed by success of leukapheresis and production of sufficient (i.e. at least 4 vaccines) and qualified (phenotypic and functional requirements) vaccines. 2. Safety, assessed by microbiological testing (bacteria, yeast, fungi, mycoplasma, endotoxin) of the DC vaccines.

  Vaccine production and quality testing (i.e. 4 weeks after leukapheresis)

• Number of patients receiving investigational DC vaccine administration combined with standard of care chemotherapy within the proposed time frame

  Administration of 4 autologous DC vaccines combined with four 3-weekly platinum/pemetrexed-based chemotherapy cycles will be evaluated for: 1. Feasibility, assessed by successful administration of DC vaccines and prior to surgery in case of resectable disease. 2. Safety, assessed by local (e.g. skin reactions at injection site) and systemic (toxicity grading according to the latest version of the CTCAE and CTC ) tolerability to the treatment.

  After the chemoimmunotherapy treatment (+/- 15 weeks after entry to trial)

Secondary Outcomes (4)

• Objective clinical responses by tumor evaluation (clinical efficacy)

  Through study completion, at least after 4 DC vaccinations, prior to surgery (in case of resectable disease) + three months after the last intervention and within every 12 months during follow-up

• Overall survival (clinical efficacy)

  Through study completion, an average of 1 year

• Systemic immunogenicity

  After the fourth DC vaccine (i.e. post chemoimmunotherapy, prior to surgery in case of resectable disease)

• Local immunogenicity

  Upon surgery (P/D)

Study Arms (1)

Single Arm

EXPERIMENTAL

dendritic cell vaccination plus chemotherapy

Biological: dendritic cell vaccination plus chemotherapy

Interventions

dendritic cell vaccination plus chemotherapy 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.

Also known as: chemoimmunotherapy

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Kom Op Tegen Kanker: collaborator
• Stichting tegen Kanker: collaborator

Study Sites (3)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

AZ Middelares

Ghent, 9000, Belgium

Location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Location

Related Publications (43)

• 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.

  PMID: 16054941 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.

  PMID: 16221782 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.

  PMID: 12860938 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.

  PMID: 21737558 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.

  PMID: 21424750 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.

  PMID: 21913025 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.

  PMID: 22394996 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.

  PMID: 20179421 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.

  PMID: 17316414 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.

  PMID: 24872109 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.

  PMID: 15764728 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.

  PMID: 20167848 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.

  PMID: 19656053 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.

  PMID: 11418462 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.

  PMID: 20631300 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.

  PMID: 24253259 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.

  PMID: 21723781 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.

  PMID: 22425923 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.

  PMID: 19422663 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.

  PMID: 22301798 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.

  PMID: 8401592 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.

  PMID: 19723653 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.

  PMID: 20532500 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.

  PMID: 22291091 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.

  PMID: 8564842 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.

  PMID: 19403881 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.

  PMID: 22918928 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.

  PMID: 26240218 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.

  PMID: 25748047 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.

  PMID: 26202904 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.

  PMID: 25979846 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.

  PMID: 26386124 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.

  PMID: 26433514 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.

  PMID: 25186961 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.

  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.

  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.

  PMID: 24989696 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.

  PMID: 24324087 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.

  PMID: 24023319 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.

  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.

  PMID: 28830889 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

  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.

  BACKGROUND

MeSH Terms

Conditions

Mesothelioma, Malignant; Wilms Tumor

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Zwi N Berneman, MD, PhD

  Antwerp University Hospital, Division of Hematology and Center for Cell Therapy and Regenerative Medicine

  STUDY DIRECTOR

• Eva Lion, MSc, PhD

  University of Antwerp, Laboratory of Experimental Hematology

  PRINCIPAL INVESTIGATOR

• Evelien LJ Smits, MSc, PhD

  University of Antwerp, Laboratory of Experimental Hematology

  PRINCIPAL INVESTIGATOR

• Sébastien Anguille, MD, PhD

  Antwerp University Hospital, Division of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: January 8, 2016
• Study Start: October 3, 2017
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

BE (3)