acronym: Safety and Immunogenicity of V114 in Recipients of Allo-HSCT

lead_sponsor: Merck Sharp & Dohme LLC

summary: The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop chronic graft-versus-host disease [GVHD]).

ReferenceType: result

ReferenceCitation: Wilck M, Cornely OA, Cordonnier C, Velez JD, Ljungman P, Maertens J, Selleslag D, Mullane KM, Nabhan S, Chen Q, Dagan R, Richmond P, Daus C, Geddie K, Tamms G, Sterling T, Patel SM, Shekar T, Musey L, Buchwald UK; V114-022 (PNEU-STEM) Study Group. A Phase 3, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate Safety, Tolerability, and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Allogeneic Hematopoietic Cell Transplant Recipients (PNEU-STEM). Clin Infect Dis. 2023 Oct 13;77(8):1102-1110. doi: 10.1093/cid/ciad349.

publisher_dissemination: Oxford University Press

location_facility: Universitaetsklinikum Duesseldorf ( Site 0107)

location_facility: University of Kansas Medical Center ( Site 0007)

location_facility: Instituto Nacional de Pediatria ( Site 0062)

location_facility: Universitaetsklinikum Koeln ( Site 0105)

location_facility: Instituto Nacional de Cancerologia. ( Site 0060)

location_facility: Karolinska Universitetssjukhuset ( Site 0143)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0122)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0075)

location_facility: Austin Health-Austin Hospital ( Site 0038)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0050)

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0121)

location_facility: CHU de Grenoble Hopital Nord ( Site 0083)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0031)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0145)

location_facility: Indiana Blood and Marrow Transplantation ( Site 0001)

location_facility: Cleveland Clinic Foundation ( Site 0168)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0033)

location_facility: Baylor College of Medicine - Texas Children's Hospital ( Site 0165)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 0051)

location_facility: Children's Hospital Colorado ( Site 0166)

location_facility: Cincinnati Children's Hospital Medical Center ( Site 0010)

location_facility: Hospital Infantil de Mexico Federico Gomez ( Site 0061)

location_facility: Hopital Jean Minjoz Besancon ( Site 0085)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0058)

location_facility: AZ Sint Jan Brugge-Oostende ( Site 0118)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0090)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0187)

location_facility: Oregon Health & Science University ( Site 0018)

location_facility: The Children s Hospital at Westmead ( Site 0191)

location_facility: Servicio de hematologia Universidad Autonoma de Nuevo Leon ( Site 0057)

title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

primary_purpose: Prevention

location_country:
Germany
Colombia
Australia
Brazil
Sweden
Mexico
Belgium
United States
Canada
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: ChemoCentryx

summary: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia

ReferenceType: derived

ReferenceCitation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: CISSS de la Monteregie-Centre - Hopital Charles LeMoyne

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Cambridge University - Addenbrooke's Hospital

location_facility: Sunnybrook Health Sciences Centre (Odette Cancer Center)

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnez Centralny Szpital

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: University of Texas Health Sciences Center

location_facility: Salford Royal NHS Foundation Trust Manchester

location_facility: Los Angeles Biomedical Research Institute

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - II Klinika Nefrologii z Oddzialem Leczenia Nadcisnienia Tetniczego i Pododdzialem Dializoterapii

location_facility: Presidio Ospedaliero di Montichiari-A.O. Spedali Civili di Brescia

location_facility: Uniwersytecki Szpital Kliniczny Klinika Nefrologii i Medycyny Transplantacyjnej

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

status: Completed

title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)

primary_purpose: Treatment

type: Other Identifier

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Italy
Poland
New Zealand
United Kingdom
Australia
United States
Canada
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

summary: This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Germany
Australia
Japan
Thailand
Canada
Serbia
France
Colombia
Hong Kong
United States
Belgium
Malaysia
Peru
Philippines
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Bulgaria
Russian Federation

location_facility: Hospital Universitario "José Eleuterio González", UANL

location_facility: Hospital Univ. de Gran Canaria Dr.Negrin

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Hospital Universitario Politecnico La Fe

location_facility: Centro de Investigacion en Hematologia Clinica del Centro Medico Corpac

location_facility: Investigative Clinical Research of Indiana

location_facility: Hospital Center Chalon Sur Saone William Morey

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Centre Hospitalier Annecy Genevois - Site Annecy

location_facility: Hospital Nacional Dos De Mayo - Centro de Investigación

location_facility: Essen University Hospital Department of Hematology

location_facility: Therapeutic hospital of regional clinical hospital #1

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

status_simplified: Ongoing


type: EudraCT Number

title: A Phase II, Open Label, Randomized, Two-Arm Study to Investigate the Efficacy and Safety of Two Doses of the Antibody Drug Conjugate GSK2857916 in Participants With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody (DREAMM 2)

summary: Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.

ReferenceType: background

ReferenceCitation: S Lonial, HC Lee, A Badros, S Trudel, AK Nooka, A Chari, A-O Abdallah, N Callander, N Lendvai, D Sborov, A Suvannasankha, K Weisel, L Karlin, E Libby, B Arnulf, T Facon, C Hulin, KM Kortüm, P Rodríguez-Otero, SZ Usmani, P Hari, R Baz, H Quach, P Moreau, PM Voorhees, I Gupta, A Hoos, E Zhi, J Baron, T Piontek, E Lewis, RC Jewell, EJ Dettman, R Popat, S Degli Esposti, J Opalinska, P Richardson, AD Cohen. Single-agent Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma: Results of the Pivotal Phase II Randomised DREAMM-2 Study. Lancet Oncol. 2020;21(7):207-221 DOI: https://doi.org/10.1016/S1470-2045(19)30788-0 PMID: 31859245

doi: s

ReferenceCitation: Prawitz T, Popat R, Suvannasankha A, Sarri G, Hughes R, Wang F, Hogea C, Ferrante SA, Gorsh B, Willson J, Kapetanakis V. DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma. Adv Ther. 2021 Nov;38(11):5501-5518. doi: 10.1007/s12325-021-01884-7. Epub 2021 Sep 24.

ReferenceCitation: Nikolaou A, Ambavane A, Shah A, Ma W, Tosh J, Kapetanakis V, Willson J, Wang F, Hogea C, Gorsh B, Gutierrez B, Sapra S, Suvannasankha A, Samyshkin Y. Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis. Expert Rev Hematol. 2021 Dec;14(12):1137-1145. doi: 10.1080/17474086.2021.1970522. Epub 2021 Sep 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via OAI-PMH title and first author match)

license: cc-by

license_normalized: cc-by

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Informa

ReferenceCitation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Sborov D, Suvannasankha A, Weisel K, Voorhees PM, Womersley L, Baron J, Piontek T, Lewis E, Opalinska J, Gupta I, Cohen AD. Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study. Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27.

ReferenceCitation: Lonial S, Nooka AK, Thulasi P, Badros AZ, Jeng BH, Callander NS, Potter HA, Sborov D, Zaugg BE, Popat R, Degli Esposti S, Byrne J, Opalinska J, Baron J, Piontek T, Gupta I, Dana R, Farooq AV, Colby K, Jakubowiak A. Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J. 2021 May 26;11(5):103. doi: 10.1038/s41408-021-00494-4.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Farooq AV, Degli Esposti S, Popat R, Thulasi P, Lonial S, Nooka AK, Jakubowiak A, Sborov D, Zaugg BE, Badros AZ, Jeng BH, Callander NS, Opalinska J, Baron J, Piontek T, Byrne J, Gupta I, Colby K. Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study. Ophthalmol Ther. 2020 Dec;9(4):889-911. doi: 10.1007/s40123-020-00280-8. Epub 2020 Jul 25. Erratum In: Ophthalmol Ther. 2020 Sep 12;:

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, Abdallah AO, Callander N, Lendvai N, Sborov D, Suvannasankha A, Weisel K, Karlin L, Libby E, Arnulf B, Facon T, Hulin C, Kortum KM, Rodriguez-Otero P, Usmani SZ, Hari P, Baz R, Quach H, Moreau P, Voorhees PM, Gupta I, Hoos A, Zhi E, Baron J, Piontek T, Lewis E, Jewell RC, Dettman EJ, Popat R, Esposti SD, Opalinska J, Richardson P, Cohen AD. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020 Feb;21(2):207-221. doi: 10.1016/S1470-2045(19)30788-0. Epub 2019 Dec 16.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Australia
United States
Spain
Canada
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa

acronym: SHINE

summary: The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

ReferenceCitation: Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horvath B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9. No abstract available.

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ipd_sharing: No

lead_sponsor: InflaRx GmbH

sponsor_collaborators:
InflaRx GmbH
Quintiles, Inc.

location_country:
Germany
Poland
Denmark
Netherlands
United States
Greece
Bulgaria
Canada
France

location_facility:
InflaRx Investigational Site
InflaRX Investigational Site


title: An Open Label Phase Ib Dose Finding Study of BI 836880 in Combination With Ezabenlimab to Characterize Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer and in Other Solid Tumors

summary:
This study has 2 parts. The first part was open to adults with advanced non-small cell lung cancer. The second part was open also to adults with other types of advanced cancer of the lung, brain, skin, and liver. After early encouraging results, more people with liver cancer can now take part in the study. The participants get a combination of two medicines called BI 836880 and ezabenlimab.

BI 836880 is a type of an antibody that blocks new blood vessel formation. New blood vessels are needed by the tumour to continue growing. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor).

The purpose of the first part of the study was to find out the highest dose of the BI 836880 that the participants can tolerate in combination with BI 754091. After the best dose of BI 836880 for the combination with ezabenlimab was found, it is used in the second part of the study. The purpose of the second part is to see whether the combination of BI 836880 and BI 754091 is able to make tumours shrink.

The participants are in the study as long as they benefit from and can tolerate treatment. During this time, they get infusions of BI 836880 and ezabenlimab every 3 weeks. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Poland
United Kingdom
Hong Kong
Australia
United States
Korea, Republic of
Spain
Taiwan
Ukraine
Russian Federation
France

location_facility: Peninsula & South Eastern Oncology Group

location_facility: MED POLONIA SP Z O O, Clinical Trials Department,Poznan

location_facility: Mandziuk Slawomir Specialist Medical Practice

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: SBHI "Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncological)"

location_facility: Seoul National University Bundang Hospital

location_facility: Medical and Preventive Treatment Inst. Volyn Regional, Lutsk

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: State Budget Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council


title: A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies

summary: This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

lead_sponsor: Eisai Inc.

location_country:
Germany
Italy
United Kingdom
Japan
United States
Spain
France

location_facility: Clinica Neurologica Azienda Ospedaliera di Padova

location_facility: New England Institute for Clinical Research

location_facility: Pharmax Research of South Florida; Elias Research Associates

location_facility: New Orleans Center for Clinical Research

location_facility: Institut Internacional de Neurociències Aplicades

location_facility: Manchester Mental Health and Social Care Trust

location_facility: Centre d'Investigation Clinique (CIC) Hopitaux universitaires Strasbourg HOPITAL DE HAUTEPIERRE - BATIMENT AX5

location_facility: Memory Assessment and Research Centre, Moorgreen Hospital

location_facility: University of Kentucky, Dept of Neurology Sanders Brown Center on Aging

location_facility: Elias Research Associates (Allied Biomedical Research Institute)

location_facility: Parkinsons and Movement Disorders Institute

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: CHRU Nancy- CMRR de lorraine Hôpital de Brabois-Service de Gériatrie

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centre de Recherche Clinique - Viellissement-Cerveau-Fragilite (CRC-VCF), Hopital des Charpennes

location_facility: Cleveland Clinic, Lou Ruvo Center for Brain Health at Lakewood Hospital


acronym: SEAVUE

intervention_type: Biological

lead_sponsor: Janssen Scientific Affairs, LLC

summary: The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

ReferenceCitation: Sands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: Gastroenterology Research of America, LLC

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Saratoga Schenectady Gastroenterology Associates

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Western Connecticut Health Network/Danbury Hospital

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: GU Moscow Regional Research Clinical Institute n.a. M.F.Vla

location_facility: Premier Medical Group Of The Hudson Valley, Pc

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Southampton University Hospitals NHS Trust

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: University of North Carolina at Chapel Hill

location_facility: Gastroenterology Associates of Tidewater

location_facility: Gastro Associates of Fairfield County PC

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: The Catholic university of Korea, St. Vincent's Hospital

location_facility: Endoskopia Sp. z o.o. z siedzibą w Sopocie

location_facility: Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

location_facility: University of Texas at Houston Medical School

location_facility: Seoul National University Bundang Hospital

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

location_facility: Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina

location_facility: Pennine Acute Hospitals-Fairfield General Hospital

location_facility: Gastroenterology Associates of Central Virginia

location_facility: University Hospitals Case Medical Center

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Oddział Gastroenterologii

location_facility: Mater Hospital Brisbane (Inflammatory Bowel Diseases)

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Huron Gastroenterology Associates Center for Digestive Care

title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Czechia
Bulgaria
Canada
Serbia
Russian Federation
France


title: A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.

ReferenceCitation: Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Serbia
France
Slovenia
Hungary
Switzerland
United States
Ukraine
China
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Klinikum der Univer Regenburg; Klinik und Poliklinik fuer Inn

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Uppsala University Hospital; Department of Oncology

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Uni Hospital in Lund; Respiratory Medicine & Allergology

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset

location_facility: Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Nebraska Methodist Estabrook Cancer Center

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1


title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

acronym: CYPIDES

summary: The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

status: Recruiting

design_allocation: Non-Randomized

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
United States
United Kingdom
Finland
France

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: The Rutherford Cancer Centre, North West

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: The Rutherford Cancer Centre, North East

location_facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center

location_facility: University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative

location_facility: Institut de cancérologie Strasbourg Europe


acronym: BRIGHT AML1019

lead_sponsor: Pfizer

summary:
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).

Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).

ReferenceCitation: Cortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13.

evidence: open (via page says license)

publisher_dissemination: Future Science Ltd

location_facility: Szabolcs-Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Korhaz, Hematologia

location_facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia

location_facility: Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie

location_facility: The First Affiliated Hospital of USTC, Anhui Provincial Hospital

location_facility: Spitalul Clinic Coltea, Clinica de Hematologie

location_facility: Henan Provincial People's Hospital/Hematology Department

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: AO Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro -

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Interni hematologicka a onkologicka klinika, Fakultni nemocnice Brno

location_facility: The First Affiliated Hospital College of Medicine, Zhejiang University

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola Malpighi

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: CIUSSS de l'Est-de-l'Ile-de- Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Interní hematologická klinika, Fakultni nemocnice Královské Vinohrady

location_facility: Blood Cancer and Stem Cell Transplant Clinic

location_facility: Institutul Oncologic 'Prof. Dr. Ion Chiricuta'

location_facility: Petz Aladár Megyei Oktató Kórház, II. Belgyógyászat- Hematológiai Osztály

location_facility: Methodist Healthcare System of San Antonio

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Tufts Medical Center Investigational Drug Pharmacy

location_facility: State Budgetary Healthcare Institution of Moscow

location_facility: Guangdong Second Provincial General Hospital

location_facility: UC Irvine Health - Chao Family Comprehensive Cancer Center

location_facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: State Budgetary Institution of Ryazan Region 'Regional Clinical Hospital' (SBI RR RCH)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Sp. Clinic de Urgenta Militar Central Dr. Carol Davila

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: UCLA Drug Information/Investigational Drugs

location_facility: Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Azienda Ospedaliera Universitaria Senese.

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Georgia Cancer Center at Augusta University

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek

location_facility: Universitaire Ziekenhuizen Brussel (UZ Brussel)

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Clinical Trial Center, Severance Hospital, Yonsei University Health System

location_facility: Uniklinikum Salzburg, Landeskrankenhaus Salzburg

location_facility: UCLA Hematology/Oncology - Westlake Village

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: A.O.U. di Ferrara- Arcispedale Sant'Anna,

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie

location_facility: MidAmerica Division, Inc., c/o Research Medical Center

location_facility: SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

title: A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Hungary
United States
Romania
Belgium
China
Italy
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

summary: The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Canada
France
United States
Ukraine
Belgium
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden

location_facility: Policlinic of State Joint Stock Holding Company 'Artem'

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

location_facility: Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna

location_facility: Diagnostic Consultation Centre 'Alexandrovska' EOOD

location_facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center

location_facility: Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis

location_facility: AllinaHealth - Abbott Northwestern Hospital (13520)

location_facility: Dr Anil K Gupta Medicine Professional Corporation

location_facility: Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education

location_facility: Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

location_facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

location_facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

location_facility: City Polyclinic #25 of the Nevsky District of SPB

location_facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas

location_facility: Medical Center of LL Company 'Scientific Medical Center-Your Doctor'

location_facility: SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: Universidade Federal de Santa Catarina/Clínica Médica

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Barwon Health - University Hospital Geelong

location_facility: IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

location_facility: Hospital Universitario Prof Edgard Santos

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA


lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.

status: Terminated

title: An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Finland
Germany
Ireland
Poland
Australia
Japan
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
Denmark
United States
Romania
Belgium
Estonia
Italy
United Kingdom
Mexico
Spain
Greece
Bulgaria

status_simplified: Unknown


lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

summary: This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

ReferenceCitation: Knupp KG, Scheffer IE, Ceulemans B, Sullivan JE, Nickels KC, Lagae L, Guerrini R, Zuberi SM, Nabbout R, Riney K, Shore S, Agarwal A, Lock M, Farfel GM, Galer BS, Gammaitoni AR, Davis R, Gil-Nagel A. Efficacy and Safety of Fenfluramine for the Treatment of Seizures Associated With Lennox-Gastaut Syndrome: A Randomized Clinical Trial. JAMA Neurol. 2022 Jun 1;79(6):554-564. doi: 10.1001/jamaneurol.2022.0829.

evidence: open (via free pdf)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: American Medical Association

title: A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Germany
Italy
Poland
Denmark
Australia
Japan
Netherlands
Mexico
Belgium
Sweden
United States
Spain
Canada
France


title: A Phase III Trial of Marizomib in Combination With Standard Temozolomide-based Radiochemotherapy Versus Standard Temozolomide-based Radiochemotherapy Alone in Patients With Newly Diagnosed Glioblastoma

acronym: MIRAGE

summary: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

collaborators:
Celgene
Canadian Cancer Trials Group

location_country:
Germany
Norway
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

location_facility: Hamilton Health Sciences, Juravinski Cancer Centre

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

location_facility: Universitaetsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: QEII Health Sciences Centre-Capital District Health Authority

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Regional Cancer Program of Hopital Reg. de Sudbury Reg. Hospital

location_facility: University Health Network - Oci / Princess Margaret Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie

location_facility: Clinica Universidad de Navarra - Clinica Universitaria De Navarra

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Universitaetsklinik Erlangen-Neurologische Klinik (3031)

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: University Hospitals Copenhagen - Rigshospitalet

location_facility: Penn State College of Medicine, Hershey Medical Center-Penn State Neuroscience Institute

location_facility: Universitaetsklinikum Tuebingen- Crona Kliniken

location_facility: Montreal Neurological Institute and Hospital McGill University

location_facility: Aarhus University Hospitals - Aarhus University Hospital (440)

location_facility: Centre hospitalier regional de Trois-Rivieres

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Radboud University Medical Center Nijmegen


title: A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

summary: A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

lead_sponsor: Opthea Limited

location_country:
France
Italy
Poland
Hungary
United Kingdom
United States
Latvia
Spain
Czechia
Israel

location_facility:
Opthea Investigational Site
Opthea Investigationa Site
Opthea Study Site

intervention_type: Other


acronym: Morpheus Lung

summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Hospital Regional Universitario de Malaga

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole; PHARMACIE

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Chonnam National University Hwasun Hospital

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

location_facility: Institut Régional du Cancer de Montpellier

location_facility: National Cheng Kung University Hospital; Gasterointestinal

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: University Hospitals Case Medical Center; Seidman Cancer Center

title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

location_country:
France
United Kingdom
Australia
United States
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed/refractory (R/R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R/R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R/R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).

ReferenceCitation: Bahlis NJ, Baz R, Harrison SJ, Quach H, Ho SJ, Vangsted AJ, Plesner T, Moreau P, Gibbs SD, Coppola S, Yang X, Al Masud A, Ross JA, Bueno O, Kaufman JL. Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14). J Clin Oncol. 2021 Nov 10;39(32):3602-3612. doi: 10.1200/JCO.21.00443. Epub 2021 Aug 13.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;sdu.dk

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

sponsor_collaborators:
AbbVie
Janssen Research & Development, LLC

location_country:
Germany
Denmark
Australia
Japan
United States
Canada
France

location_facility: Beth Israel Deaconess Medical Center /ID# 210904

location_facility: Matsuyama Red Cross Hospital /ID# 225196

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 167824

location_facility: St Vincent's Hospital Melbourne /ID# 165853

location_facility: Universitaetsklinikum Freiburg /ID# 166036

location_facility: Atrium Health Carolinas Medical Center /ID# 164948

location_facility: CHRU Tours - Hopital Bretonneau /ID# 164795

location_facility: Univ of Colorado Cancer Center /ID# 167331

location_facility: Nagoya City University Hospital /ID# 225273

location_facility: The University of Chicago Medical Center /ID# 165429

location_facility: Emory University, Winship Cancer Institute /ID# 165427

location_facility: Roswell Park Comprehensive Cancer Center /ID# 169615

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 164767

location_facility: Oregon Health & Science University /ID# 166822

location_facility: Dana-Farber Cancer Institute /ID# 166886


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

summary: The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

ReferenceCitation: Teng YKO, Bruce IN, Diamond B, Furie RA, van Vollenhoven RF, Gordon D, Groark J, Henderson RB, Oldham M, Tak PP. Phase III, multicentre, randomised, double-blind, placebo-controlled, 104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus (SLE): BLISS-BELIEVE study protocol. BMJ Open. 2019 Mar 20;9(3):e025687. doi: 10.1136/bmjopen-2018-025687.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

ReferenceCitation: Parodis I, Lopez Benavides AH, Zickert A, Pettersson S, Moller S, Welin Henriksson E, Voss A, Gunnarsson I. The Impact of Belimumab and Rituximab on Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2019 Jun;71(6):811-821. doi: 10.1002/acr.23718.

repositories_institution: University of Southern Denmark - University of Southern Denmark Research Portal

location_country:
Germany
Argentina
Brazil
Netherlands
Mexico
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments

acronym: FOCUS

summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments.

Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

ReferenceCitation: McAllister P, Cohen JM, Campos VR, Ning X, Janka L, Barash S. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. J Headache Pain. 2022 Aug 29;23(1):112. doi: 10.1186/s10194-022-01438-4.

ReferenceCitation: Diener HC, McAllister P, Jurgens TP, Kessler Y, Ning X, Cohen JM, Campos VR, Barash S, Silberstein SD. Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Cephalalgia. 2022 Jul;42(8):769-780. doi: 10.1177/03331024221076485. Epub 2022 Mar 25.

publisher_dissemination: SAGE Publications

ReferenceCitation: Lampl C, Rapoport AM, Cohen JM, Barash S, Ramirez Campos V, Seminerio MJ, Ning X, Silberstein SD. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 Jul;29(7):2129-2137. doi: 10.1111/ene.15328. Epub 2022 Mar 29.

ReferenceCitation: MaassenVanDenBrink A, Terwindt GM, Cohen JM, Barash S, Campos VR, Galic M, Ning X, Karppa M. Impact of age and sex on the efficacy of fremanezumab in patients with difficult-to-treat migraine: results of the randomized, placebo-controlled, phase 3b FOCUS study. J Headache Pain. 2021 Dec 18;22(1):152. doi: 10.1186/s10194-021-01336-1.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Leiden University - Leiden Repository

repository_institution: University of Oulu - University of Oulu Repository - Jultika

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged >/=60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2. Erratum In: J Headache Pain. 2022 May 17;23(1):57.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

repositories_concat: PubMed Central;jdc.jefferson.edu

ReferenceCitation: Ashina M, Cohen JM, Galic M, Campos VR, Barash S, Ning X, Kessler Y, Janka L, Diener HC. Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study. J Headache Pain. 2021 Jul 10;22(1):68. doi: 10.1186/s10194-021-01279-7.

ReferenceCitation: Pazdera L, Cohen JM, Ning X, Campos VR, Yang R, Pozo-Rosich P. Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. Cephalalgia. 2021 Sep;41(10):1075-1088. doi: 10.1177/03331024211008401. Epub 2021 May 14.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Spierings ELH, Karppa M, Ning X, Cohen JM, Campos VR, Yang R, Reuter U. Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial. J Headache Pain. 2021 Apr 16;22(1):26. doi: 10.1186/s10194-021-01232-8.

ReferenceCitation: Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16. Erratum In: Lancet. 2019 Oct 29;:

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Denmark
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Czechia
France

location_facility:
Teva Investigational Site 40035
Teva Investigational Site 54157
Teva Investigational Site 39052
Teva Investigational Site 35236
Teva Investigational Site 31229
Teva Investigational Site 42049
Teva Investigational Site 38124
Teva Investigational Site 42051
Teva Investigational Site 14734
Teva Investigational Site 31235
Teva Investigational Site 14746
Teva Investigational Site 42052
Teva Investigational Site 53417
Teva Investigational Site 32689
Teva Investigational Site 14738
Teva Investigational Site 37092
Teva Investigational Site 53416
Teva Investigational Site 14745
Teva Investigational Site 14749
Teva Investigational Site 54163
Teva Investigational Site 54161
Teva Investigational Site 53423
Teva Investigational Site 14751
Teva Investigational Site 14754
Teva Investigational Site 40034
Teva Investigational Site 31234
Teva Investigational Site 14730
Teva Investigational Site 35235
Teva Investigational Site 32691
Teva Investigational Site 14758
Teva Investigational Site 31228
Teva Investigational Site 38126
Teva Investigational Site 54165
Teva Investigational Site 45016
Teva Investigational Site 14737
Teva Investigational Site 14742
Teva Investigational Site 32692
Teva Investigational Site 32695
Teva Investigational Site 14736
Teva Investigational Site 53418
Teva Investigational Site 14729
Teva Investigational Site 14743
Teva Investigational Site 54159
Teva Investigational Site 39050
Teva Investigational Site 32694
Teva Investigational Site 39048
Teva Investigational Site 54166
Teva Investigational Site 14735
Teva Investigational Site 14760
Teva Investigational Site 40036
Teva Investigational Site 40033
Teva Investigational Site 34230
Teva Investigational Site 14741
Teva Investigational Site 32698
Teva Investigational Site 30199
Teva Investigational Site 14843
Teva Investigational Site 35239
Teva Investigational Site 53420
Teva Investigational Site 38125
Teva Investigational Site 37089
Teva Investigational Site 14752
Teva Investigational Site 14747
Teva Investigational Site 53425
Teva Investigational Site 40037
Teva Investigational Site 42054
Teva Investigational Site 45018
Teva Investigational Site 31225
Teva Investigational Site 14748
Teva Investigational Site 54160
Teva Investigational Site 14731
Teva Investigational Site 45017
Teva Investigational Site 32690
Teva Investigational Site 38127
Teva Investigational Site 53422
Teva Investigational Site 14750
Teva Investigational Site 54164
Teva Investigational Site 14753
Teva Investigational Site 32693
Teva Investigational Site 34231
Teva Investigational Site 14756
Teva Investigational Site 32697
Teva Investigational Site 32700
Teva Investigational Site 54158
Teva Investigational Site 53424
Teva Investigational Site 42050
Teva Investigational Site 39049
Teva Investigational Site 35238
Teva Investigational Site 34233
Teva Investigational Site 14739
Teva Investigational Site 14740
Teva Investigational Site 14761
Teva Investigational Site 37091
Teva Investigational Site 30204
Teva Investigational Site 37090
Teva Investigational Site 34232
Teva Investigational Site 31230
Teva Investigational Site 39051
Teva Investigational Site 31236
Teva Investigational Site 14733
Teva Investigational Site 34236
Teva Investigational Site 31231
Teva Investigational Site 14732
Teva Investigational Site 34235
Teva Investigational Site 32701
Teva Investigational Site 31233
Teva Investigational Site 35240
Teva Investigational Site 53419
Teva Investigational Site 40032
Teva Investigational Site 54162
Teva Investigational Site 31227
Teva Investigational Site 35237
Teva Investigational Site 32699
Teva Investigational Site 31226


title: Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)

summary: Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.

location_country:
Germany
United Kingdom
Japan
Belgium
United States
Canada
France


type: Registry Identifier

title: Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

acronym: IKEMA

summary: The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.

ReferenceCitation: Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Spicka I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Risse ML, Asset G, Mace S, Martin T; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.

ReferenceCitation: Martin TG, Capra M, Mohty M, Suzuki K, Quach H, Cavo M, Moreau P, Dimopoulos M, Yong K, Tekle C, Foster MC, Barnes Y, Risse ML, Mikhael J. Isatuximab Plus Carfilzomib and Dexamethasone Versus Carfilzomib and Dexamethasone in Patients with Relapsed Multiple Myeloma: IKEMA Subgroup Analysis by Prior Transplantation. Transplant Cell Ther. 2023 Feb;29(2):134.e1-134.e7. doi: 10.1016/j.jtct.2022.11.005. Epub 2022 Nov 11.

ReferenceCitation: Chami B, Okuda M, Moayeri M, Pirenne F, Hidaka Y, Nambiar A, Song Z, Bedel O, Zhang B, Hopke J, Deng G, Zhu C, Mace S, Chiron M, Adrian F, Fukao T, Basile FG, Martin T. Anti-CD38 monoclonal antibody interference with blood compatibility testing: Differentiating isatuximab and daratumumab via functional epitope mapping. Transfusion. 2022 Nov;62(11):2334-2348. doi: 10.1111/trf.17137. Epub 2022 Oct 14.

ReferenceCitation: Moreau P, Dimopoulos MA, Yong K, Mikhael J, Risse ML, Asset G, Martin T. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design. Future Oncol. 2020 Jan;16(2):4347-4358. doi: 10.2217/fon-2019-0431. Epub 2019 Dec 13.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Italy
New Zealand
Hungary
United Kingdom
Australia
Brazil
Japan
United States
Korea, Republic of
Spain
Greece
Turkey
Czechia
Canada
Russian Federation
France

location_facility: Hospital das Clinicas de Sao Paulo Site Number : 0760002

location_facility: Spartanburg Medical Center Site Number : 8400003

location_facility: Hospital Sao Rafael Site Number : 0760005

location_facility: Instituto COI de Educacao e Pesquisa Site Number : 0760004

location_facility: Hospital Mae de Deus Site Number : 0760003

location_facility: Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001


title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

summary:
Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups.

The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data.

Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose.

Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group.

Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days.

Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days.

Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.

lead_sponsor: Proteostasis Therapeutics, Inc.

location_country:
Germany
New Zealand
United Kingdom
Denmark
Australia
Belgium
United States
Canada
France

location_facility: Hôpital Maison Blanche Maladies respiratoires et allergologie

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: University of North Carolina at Chapel Hill

location_facility: Banner University of Arizona Medical Center

location_facility: Michigan Medicine, University of Michigan


title: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

summary: To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

ReferenceCitation: North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol. 2016 May 20;226:24-34. doi: 10.1016/j.jbiotec.2016.03.032. Epub 2016 Mar 23.

ReferenceCitation: Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016 Dec 10;239:115-125. doi: 10.1016/j.jbiotec.2016.10.010. Epub 2016 Oct 13.

ReferenceCitation: Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotechnol Rep (Amst). 2017 May 17;15:24-26. doi: 10.1016/j.btre.2017.05.002. eCollection 2017 Sep.

lead_sponsor: Soligenix

location_country:
United Kingdom
Belgium
United States
Spain
France

location_facility: University of Missouri-Ellis Fischel Cancer Center

location_facility: Centre Hospitalier Universitaire de Mons

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Regional Universitario de Málaga

location_facility: Spartanburg Regional-Gibbs Cancer Center

location_facility: Des Moines Oncology Research Association

location_facility: Hospital Clínico Universitario Lozano Blesa


title: Personalized CRT - Multiple Point Pacing Post Approval Study

summary: The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Germany
Italy
Slovakia
Hungary
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Malaysia
Canada
France

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Mercy Health - Saint Vincent Medical Center

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Washington University School of Medicine

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: The University of Vermont Medical Center

location_facility: Institut de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: North Memorial Heart and Vascular Institute

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: Centre hospitalier de la région d'Annecy

intervention_type: Device


title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis

summary: To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
Poland
Australia
Canada
Serbia
France
Denmark
Switzerland
United States
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Sweden


title: A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors

summary:
Primary Objectives:

Dose escalation (Part 1)

Part 1A (SAR439459 monotherapy)

To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors.

Part 1B (SAR439459 and cemiplimab combination therapy)

To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors.

Dose expansion (Part 2)

Part 2A (SAR439459 monotherapy)

To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1.

Part 2B (SAR439459 and cemiplimab combination therapy)

To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).

Secondary Objectives:

Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459.
Immunogenicity of SAR439459 monotherapy and combined with cemiplimab.

Dose escalation (Part 1)

Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab.
Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab.

Dose expansion (Part 2)

Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab.
To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

ReferenceCitation: Greco R, Qu H, Qu H, Theilhaber J, Shapiro G, Gregory R, Winter C, Malkova N, Sun F, Jaworski J, Best A, Pao L, Hebert A, Levit M, Protopopov A, Pollard J, Bahjat K, Wiederschain D, Sharma S. Pan-TGFbeta inhibition by SAR439459 relieves immunosuppression and improves antitumor efficacy of PD-1 blockade. Oncoimmunology. 2020 Sep 13;9(1):1811605. doi: 10.1080/2162402X.2020.1811605.

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Estonia
France

location_facility:
Investigational Site Number :0360001
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Investigational Site Number :0560002
Investigational Site Number :7240003
Investigational Site Number :2760003
Investigational Site Number :5280005
Investigational Site Number :2500003
Investigational Site Number :7240004


title: A Global Epidemiologic Study to Determine the Prevalence of Neutralizing Antibodies and Related Adaptive Immune Responses to Adeno-Associated Virus (AAV) in Adults With Hemophilia

summary: Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia B (coagulation factor IX [FIX] ≤2%).

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Germany
Italy
Austria
United States
Spain
France

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital Regional Universitario de Malaga

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: Presidio Ospedaliero di Castelfranco Veneto

location_facility: Azienda Ospedaliera Universitaria Careggi


summary: The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

location_facility: University North Carolina at Chapel Hill

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: University of Iowa, Carver College of Medicine

location_facility: IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego

location_facility: Vadaskert Gyermek- és Ifjúságpszichiátriai Kórház és Szakambulancia

location_facility: Hospital Universitario Professor Edgar Santos

location_facility: Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ

location_facility: Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy

location_facility: University of Texas Southwestern Medical Center

title: A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

location_country:
Italy
Poland
Hungary
Brazil
Belgium
United States
Spain
Bulgaria
France


lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

ReferenceCitation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

publisher_dissemination: British Medical Journal

ReferenceCitation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

ReferenceCitation: Smolen JS, Sebba A, Ruderman EM, Schulze-Koops H, Sapin C, Gellett AM, Sprabery AT, Li L, de la Torre I, Gallo G, Liu-Leage S, Pillai S, Reis P, Nash P. Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naive Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study. Rheumatol Ther. 2020 Dec;7(4):1021-1035. doi: 10.1007/s40744-020-00250-3. Epub 2020 Nov 16.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Gratacos J, Goupille P, Liu Leage S, Pillai S, Nash P. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naive to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Regional Clinical Hospital Center for Emergency medical care

location_facility: Centre Hospitalier de Vendee Les Oudairies

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Regional Clinical Hospital of Zaporizhzhia

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Organizacion Medica de Investigacion - OMI

location_facility: Multifield Medical Center of Odesa NMU (University Clinic#1)

location_facility: Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna

location_facility: Centro Investigacion de Tratam Innovadores de Sinaloa SC

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC

location_facility: Rheumatology, The Queen Elizabeth Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol

location_facility: Krishna Institute of Medical Sciences Ltd.

location_facility: Centro de Medicina Familiar Mindout Research

location_facility: Aalborg Universitetshospital - Psykiatrien

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö

location_facility: Zentrum für klinische Studien Dr. Ursula Hanusch GmbH

location_facility: National Scientific Center "Strazhesko institute of cardio"

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Government Medical College & Sir Sayajirao General Hospital

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Instituto de Asist Reumatologica Integral

location_facility: Municipal Institution of Ternopil Regional Council

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

title: A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Finland
Germany
Poland
Argentina
Australia
Canada
France
Hungary
Denmark
Switzerland
Ukraine
India
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
South Africa
Israel


acronym: CheckMate 648

summary: The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

ReferenceCitation: Kato K, Doki Y, Ogata T, Motoyama S, Kawakami H, Ueno M, Kojima T, Shirakawa Y, Okada M, Ishihara R, Kubota Y, Amaya-Chanaga C, Chen T, Matsumura Y, Kitagawa Y. First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50). Esophagus. 2023 Apr;20(2):291-301. doi: 10.1007/s10388-022-00970-1. Epub 2022 Nov 19.

ReferenceCitation: Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Ostoich SA, Kim HR, Ueno M, Mansoor W, Yang WC, Liu T, Bridgewater J, Makino T, Xynos I, Liu X, Lei M, Kondo K, Patel A, Gricar J, Chau I, Kitagawa Y; CheckMate 648 Trial Investigators. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022 Feb 3;386(5):449-462. doi: 10.1056/NEJMoa2111380.

oa_colors: green other

repositories_concat: UCL Discovery;sdu.dk

repositories_institution: University College London - UCL Discovery

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_facility: Hackensack Meridian Jersey Shore University Medical Center

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

location_facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.

title: A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

location_country:
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Denmark
United States
Romania
China
Peru
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation