title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
Japan
Poland
Portugal
Russian Federation
Australia
Argentina
Puerto Rico
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: Washington University School of Medicine

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

location_facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Allied Biomedical Research Institute, Inc

location_facility: National Taiwan University Hospital; Neurology

location_facility: National Clinical Research Inc.-Richmond

location_facility: University of Nebraska Medical Center; Dept of Neurological Sciences

location_facility: Center for Diagnosis and Research on Alzheimer's disease

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Medical corporation Ichiekai Itsuki Hospital

location_facility: Alzheimer's Research and Treatment Center

location_facility: Neurological Associates of Long Island, PC

location_facility: Advanced Memory Research Institute of NJ

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: National Neuroscience Institute; Neurology

location_facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta

location_facility: Hospital Ruber Internacional; Servicio de Neurología

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: The University of Texas Health Science Center at Houston

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: University of Puerto Rico - Medical Science Campus; Internal Medicine

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: Tokyo Bay Advanced Medical and Makuhari Clinic

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow

location_facility: Instituto de Neurociencias San Agustín S.A.

location_facility: National University Hospital (NUH); Neuroscience

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

location_facility: Beijing Tian Tan Hospital,Capital Medical University

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Australian Alzheimer's Research Foundation

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: Vilnius University Hospital Santariskiu Clinics; Neurology

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Fundación Scherbovsky; General Department

location_facility: Hospital Victoria Eugenia; Servico Neurología

location_facility: Neurology Consultants of Dallas; Research Department

location_facility: Kaohsiung Medical University Hospital; Neurology

location_facility: The Medical Arts Health Research Group - West Vancouver

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Center for Advanced Research & Education

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Tokyo Medical and Dental University Hospital

location_facility: CEN Centro Especializado en Neurociencias

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Hospital Universitario de Santa Maria; Servicio de Neurología

location_facility: National Center for Geriatrics and Gerontology

location_facility: Complejo Asistencial de Zamora; Servicio Psiquiatria

location_facility: University of Mississippi Medical Center

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: China Medical University Hospital; Neurology

location_facility: Semmelweis University; Department of Neurology

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Instituto Geriatrico Nuestra Señora de las Nieves

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Hyogo Prefectural HarimaHimeji General Medical Center

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Seoul National University Bundang Hospital

location_facility: MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: University Southampton NHS Foundation Trust; Wessex Neurologica Centre

location_facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

location_facility: Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health - Neurological Institute

location_facility: Surrey and Borders NHS Foundation Trust; Research and Development Department

location_facility: Hôpital Avicenne; Centre de Recherche Clinique

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Ohio State University; College of Medicine

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia

location_facility: Southern Illinois University, School of Medicine

location_facility: Rijikai Medical Corporation Katayama Medical Clinic

location_facility: Ośrodek Badawczo-Naukowo-Dydaktyczny Chorób Otępiennych w Ścinawie

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: AD-CARE, University of Rochester Medical Center

summary: This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.


type: EudraCT Number

title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)

summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

location_country:
Saudi Arabia
Italy
Spain
Lithuania
Ukraine
United States
Romania
Philippines
South Africa
Poland
Portugal
Slovenia
Russian Federation
Puerto Rico
India
Turkey
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Germany
Bulgaria
Moldova, Republic of
Belarus
Greece
Latvia
Thailand
France

location_facility:
Research Site 599
Research Site 801
Research Site 714
Research Site 456
Research Site 757
Research Site 159
Research Site 222
Research Site 552
Research Site 337
Research Site 735
Research Site 292
Research Site 351
Research Site 503
Research Site 141
Research Site 323
Research Site 381
Research Site 359
Research Site 402
Research Site 537
Research Site 156
Research site 514
Reserach Site 275
Research Site 404
Research Site 415
Research Site 501
Research Site 534
Research Site 751
Research Site 533
Research Site 373
Research Site 326
Research Site 382
Research Site 724
Research Site 231
Research Site 106
Research site 244
Research site 483
Research Site 342
Research Site 493
Research Site 205
Research Site 706
Research Site 629
Research Site 390
Research Site 711
Research Site 453
Research Site 723
Research Site 181
Research Site 346
Research Site 536
Research Site 442
Research Site 233
Research Site 540
Research Site 272
Research Site 752
Research Site 628
Research Site 413
Research Site 171
Research Site 340
Research Site 334
Research Site 703
Research Site 251
Research Site 218
Reserach Site 451
Research Site 270
Research Site 753
Research Site 309
Research Site 344
Research Site 372
Research site 846
Research Site 286
Research Site 744
Research Site 266
Research Site 160
Research Site 759
Research Site 282
Research Site 543
Research Site 738
Research Site 417
Research Site 343
Research Site 482
Research Site 331
Research Site 191
Research SIte 284
Research Site 721
Research Site 176
Research Site 216
Research Site 614
Research site 241
Research Site 330
Research Site 416
Research Site 335
Research site 572
Research Site 353
Research Site 345
Research Site 327
Research Site 278
Research Site 329
Research Site 748
Research Site 541
Research Site 420
Research Site 726
Research site 243
Research Site 177
Research Site 158
Research Site 389
Research Site 178
Research Site 805
Research Site 707
Research Site 145
Research Site 704
Research Site 194
Research Site 633
Research Site 356
Research Site 702
Research Site 211
Research Site 512
Research Site 183
Research Site 179
Research Site 143
Research Site 740
Research Site 157
Research Site 151
Research site 274
Research Site 192
Research Site 717
Research Site 172
Research Site 561
Research Site 623
Research Site 271
Research Site 263
Research Site 154
Research Site 196
Research Site 207
Research Site 444
Research Site 261
Research Site 215
Research Site 357
Research Site 392
Research Site 403
Research Site 538
Research Site 544
Research Site 213
Research Site 632
Research Site 264
Research Site 562
Research Site 582
Research Site 539
Research Site 502
Research Site 455
Research Site 173
Research Site 201
Research Site 202
Research Site 630
Research Site 289
Research Site 262
Research Site 217
Research Site 325
Research Site 718
Research Site 458
Research Site 203
Research Site 252
Research Site 591
Research Site 631
Research Site 719
Research Site 291
Research Site 504
Research Site 386
Reserach Site 267
Research Site 804
Research Site 184
Research Site 457
Research Site 609
Research Site 338
Research Site 307
Research Site 712
Research Site 443
Research Site 624
Research Site 802
Research Site 383
Research Site 287
Research Site 803
Research Site 281
Research site 242
Research Site 743
Research Site 737
Research Site 594
Research Site 553
Research Site 276
Research Site 302
Research Site 174
Research Site 107
Research Site 511
Research Site 734
Research Site 742
Research Site 391
Research Site 273
Research Site 152
Research Site 197
Research Site 180
Research Site 388
Research Site 705
Research Site 622
Research Site 625
Research Site 626
Research Site 551
Research Site 142
Research Site 314
Research Site 627
Research Site 214
Research Site 531
Research Site 277
Research Site 385
Research Site 418
Research Site 221
Research Site 715
Research Site 293
Research Site 603
Research Site 554
Research Site 371
Research Site 321
Research Site 358
Research Site 459
Research Site 199
Research Site 232
Research Site 556
Research Site 198
Research Site 341
Research Site 741
Research Site 265
Research Site 419
Research Site 621
Research Site 182
Research Site 513
Research Site 600
Research Site 445
Research Site 105
Research Site 532
Research Site 212
Reserach Site 268
Research Site 387
Research Site 288
Research Site 596
Research Site 452
Research Site 204
Research Site 411
Research Site 746
Research Site 736
Research Site 728
Research Site 175
Research Site 324
Research Site 725
Research Site 571
Research Site 583
Research Site 412
Research Site 328
Research Site 339
Reserach Site 206
Research Site 808
Research Site 283
Research Site 332
Research Site 144
Research Site 219
Research Site 384
Research Site 535
Research Site 220
Research Site 195
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Research Site 155
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Research Site 791
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Research Site 732
Research Site 153
Research Site 101

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

summary: Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

status: Recruiting

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
Hungary
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Peru


ipd_sharing: Undecided

status: Completed

acronym: PRELUDE

title: A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

source: euctr

ReferenceType: derived

ReferenceCitation: Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Sep 27. doi: 10.1097/DAD.0000000000002316. [Epub ahead of print]

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

enrollment_type: Actual

location_country:
Germany
United States
France

summary: The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.

status_simplified: Completed


title: A Phase 3 Randomized, Open Label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

lead_sponsor: Sanofi

type: Registry Identifier

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

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Japan
Czechia
Poland
Australia
Israel
Turkey
Norway
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Greece
Ireland
New Zealand
Korea, Republic of
France

location_facility: ~University of Texas - MD Anderson Cancer Center-Site Number:8400002

location_facility: Cancer Specialist of North Florida-Site Number:8400011

location_facility: Tennessee Oncology, PLLC-Site Number:8400006

location_facility: Dana Farber Cancer Institute-Site Number:8400001

location_facility: Colorado Blood Cancer Institute-Site Number:8400007

location_facility: Novant Health Forsyth Medical Center-Site Number:8401015

summary:
Primary Objectives:

Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM

Secondary Objectives:

Safety run-in

To assess overall response rate (ORR)
To assess duration of response (DOR)
To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
To assess time to diagnostic (SLiM CRAB) progression or death
To assess time to first-line treatment for multiple myeloma (MM)
To assess the potential immunogenicity of isatuximab
Impact of abnormal cytogenetic subtype

Randomized Phase 3 - Key Secondary Objectives:

To compare between the arms

MRD negativity
Sustained MRD negativity
Second progression-free survival (PFS2)
Overall survival

Other Secondary Objectives:

To evaluate in both arms

CR rate
ORR
DOR
Time to diagnostic (SLiM CRAB) progression
Time to first-line treatment for MM
Safety and tolerability
Pharmacokinetics (PK)
Potential of isatuximab immunogenicity
Clinical outcome assessments (COAs)


status: Withdrawn

title: A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

lead_sponsor: Janssen Research & Development, LLC

type: Other Identifier

study_start_date_type: Anticipated

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Brazil
Saudi Arabia
Italy
Russian Federation
Australia
Spain
United Kingdom
Switzerland
France
Turkey
Germany

location_facility: Klinikum rechts der Isar an der Technischen Universität München

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Instituto do cancer -COR -Hospital Mae de Deus

location_facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer

location_facility: St.-Petersburg City Clinical Hospital nr 31

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Azienda Ospedaliero Universitaria di Ferrara

summary: The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

status_simplified: Unknown


acronym: BE HEARD II

intervention_type: Other

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

lead_sponsor: UCB Biopharma SRL

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:
Poland
Spain
Ireland
United Kingdom
Australia
Canada
Hungary
United States
France
Israel
Japan
Germany
Bulgaria
Czechia

summary: The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)


intervention_type: Biological

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Shah MA, Bennouna J, Doi T, Shen L, Kato K, Adenis A, Mamon HJ, Moehler M, Fu X, Cho BC, Bordia S, Bhagia P, Shih CS, Desai A, Enzinger P. KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma. Future Oncol. 2021 Apr;17(10):1143-1153. doi: 10.2217/fon-2020-0969. Epub 2021 Feb 3.

location_country:
United Kingdom
Italy
United States
Peru
Romania
Philippines
Belgium
Japan
Hong Kong
Portugal
Russian Federation
Argentina
Turkey
Brazil
Canada
Guatemala
Hungary
China
Germany
Denmark
Taiwan
Estonia
Korea, Republic of
France
Chile

location_facility: Severance Hospital Yonsei University Health System ( Site 0624)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 0202)

location_facility: Orszagos Onkologiai Intezet ( Site 0263)

location_facility: Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0237)

location_facility: Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)

location_facility: Thompson Cancer Survival Center ( Site 0696)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0695)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0281)

location_facility: MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0298)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0201)

location_facility: Universitaetsklinikum Koeln ( Site 0251)

location_facility: Korea University Guro Hospital ( Site 0621)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)

location_facility: Centre Georges Francois Leclerc ( Site 0223)

location_facility: Hangzhou First People's Hospital ( Site 0530)

location_facility: The Affiliated Hospital of Xuzhou Medical University ( Site 0522)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0642)

location_facility: Zhongshan Hospital Fudan University ( Site 0502)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0

location_facility: China Medical University Hospital ( Site 0646)

location_facility: İstanbul University Cerrahpaşa Medical Faculty ( Site 0452)

location_facility: National Cancer Center Hospital East ( Site 0562)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)

location_facility: Clinica de Oncologia Reichow ( Site 0085)

location_facility: Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)

location_facility: Chonnam National University Hwasun Hospital ( Site 0625)

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)

location_facility: Odense Universitetshospital ( Site 0200)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0505)

location_facility: The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si

location_facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0477)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0235)

location_facility: Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)

location_facility: Affiliated Hospital of Jiangsu University ( Site 0524)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)

location_facility: Greater Baltimore Medical Center ( Site 0031)

location_facility: Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)

location_facility: Weill Cornell Medical College ( Site 0053)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)

location_facility: Institut De Cancerologie De Lorraine ( Site 0222)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 0393)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)

location_facility: Medical institute named after Berezin Sergey ( Site 0417)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)

location_facility: The Christie NHS Foundation Trust ( Site 0282)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)

location_facility: Cancer Care Northwest - Spokane Valley ( Site 0036)

location_facility: Pavlov First Saint Petersburg State Medical University ( Site 0426)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)

location_facility: Aichi Cancer Center Hospital ( Site 0563)

location_facility: Sunnybrook Research Institute ( Site 0012)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)

location_facility: National Taiwan University Hospital ( Site 0641)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0106)

location_facility: CHU Limoges Hopital Dupuytren ( Site 0225)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0538)

location_facility: University of Kansas Cancer Center ( Site 0023)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0543)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0457)

location_facility: Hospital Regional de Concepcion ( Site 0105)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)

location_facility: Princess Margaret Hospital. ( Site 0542)

location_facility: Policlinico Universitario A. Gemelli ( Site 0297)

location_facility: Baguio General Hospital and Medical Center ( Site 0603)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0476)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)

location_facility: Instituto Medico Alexander Fleming ( Site 0063)

location_facility: Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)

location_facility: Charite Campus Virchow Klinikum ( Site 0250)

location_facility: National Cancer Center Hospital ( Site 0561)

location_facility: Huai an First People s Hospital ( Site 0526)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0143)

location_facility: Columbus Regional Research Institute ( Site 0047)

location_facility: National Cheng Kung University Hospital ( Site 0645)

location_facility: University College Hospital NHS Foundation Trust ( Site 0701)

location_facility: IRCCS Policlinico San Donato ( Site 0295)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)

location_facility: Kaluga Regional Clinical Oncology Center ( Site 0424)

location_facility: Princess Margaret Cancer Centre ( Site 0011)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0261)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0008)

location_facility: MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)

location_facility: Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0087)

location_facility: Cebu Doctors University Hospital ( Site 0604)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0411)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 0471)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0033)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)

location_facility: Universitaetsklinikum Muenster ( Site 0248)

summary:
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Overall Survival (OS) and Event-free Survival (EFS) in:

participants with esophageal squamous cell carcinoma (ESCC),
participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, and
all participants.

The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:

OS in participants with ESCC,
OS in participants whose tumors express PD-L1 CPS ≥10,
OS in all participants,
EFS in participants with ESCC,
EFS in participants whose tumors express PD-L1 CPS ≥10, and
EFS in all participants.


title: A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)

summary:
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.

A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

ReferenceCitation: Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028.

ipd_sharing: No

lead_sponsor: Biotronik AG

location_country:
Denmark
Poland
Hong Kong
Spain
Italy
Austria
Australia
Latvia
Netherlands
New Zealand
Switzerland
Thailand
Hungary
France
Malaysia
Singapore
Belgium
Germany

location_facility: Somogy County Kaposi Mór Teaching Hospital

location_facility: Centre Hospitalier Universitaires Vaudoise

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH

location_facility: Assistance Publique Hopitaux de Paris (APHP)

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hospital Clinico Universitario de la Valencia

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla

location_facility: Pauls Stradins Clinical University Hospital

location_facility: IRCCS Fondazione Policlinico "San Matteo"

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio

location_facility: Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus

location_facility: Hospital Universitario Marqués de Valdecilla

intervention_type: Device


status: Terminated

acronym: Falcon

title: A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Gilead Sciences

location_country:
Poland
Italy
Austria
Australia
Canada
Switzerland
United States
France
Germany

location_facility: Vancouver General Hospital - The Gordon and Leslie Diamond Health Care Centre

location_facility: Universitätsspital Zürich/Klinik für Gastroenterologie und Hepatologie

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik fur Innere Medizin I, Haus C, Haus K3

location_facility: Gut P.C., dba Digestive Health Specialists of the Southeast

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Centre Hospitalier Universitaire de Grenoble Alpes

location_facility: Encore Borland-Groover Clinical Research

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: "GASTROMED" Kopon, Zmudzinski i Wsp. Sp. J. Spec. Centrum Gastrologii i Endoskopii, Spec. Gabinety Lekarskie

location_facility: Medizinische Universitat Wien Klinik fur Innere Medizin III/Abt. fur Gastroenterologie and Hepatologie

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Inselspital Bern/Klinik fur Viszerale Chirurgie und Medizin/Bauchzentrum

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner/Crohn-Colitis-Zentrum

location_facility: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I

location_facility: Clinical Associates in Research Therapeutics of America, LLC

summary: The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to severely active ulcerative colitis (UC).


title: A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Hack SP, Spahn J, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Yopp A, Chow P, Qin S. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncol. 2020 May;16(15):975-989. doi: 10.2217/fon-2020-0162. Epub 2020 Apr 30. Erratum in: Future Oncol. 2020 Oct;16(29):2371.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Spain
Italy
United States
Costa Rica
Peru
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Turkey
Mexico
Singapore
Brazil
Canada
China
Germany
Taiwan
New Zealand
Thailand
Korea, Republic of
France
Netherlands

location_facility: CHU Bordeaux - Hôpital Haut-Lévêque; Service d'Hépato-Gastroentérologie et d Oncologie digestive

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: The First Affiliated Hospital of China Medical University

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: Hospital do Cancer UOPECCAN; Pesquisa Clínica

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: The Tumor Hospital of Xinjiang Medical University

location_facility: The First Affiliate Hospital of Guangxi Medical University

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis; Service d'Hépatologie

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Affiliated Hospital of Bengbu Medical College

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Daping Hospital of Third Military Medical University

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.; Onkologische Gastroenterologie

location_facility: Shengjing Hospital of China Medical University

location_facility: Hopitaux de Brabois - Gastro-Entereologie

location_facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica

location_facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

location_facility: Seoul National University Bundang Hospital

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Taipei Veterans General Hospital; Gastroenterology Division

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency

location_facility: Zhujiang Hospital, Southern Medical University

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: McGill University Health Centre - Glen Site

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Hopital de Pontchaillou; Service Hepato Gastro Enterologie

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

summary: This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.


title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

summary: The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

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:CD007478. doi: 10.1002/14651858.CD007478.pub2.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Poland
Hong Kong
Portugal
Spain
Greece
Italy
Australia
Russian Federation
Argentina
Canada
Hungary
Korea, Republic of
United States
France
Mexico
Japan
Germany
Bulgaria
Czechia

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Southern California Permanente Medical Group

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Rheumatic Disease Clinical Research Center LLC

location_facility: Austin Regional Clinic Specialty Research

location_facility: Instituto Medico de Alta Complejidad San Isidro

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

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: Hospital of the University of Occupational and Environmental Health Japan

location_facility: University of Calgary Cumming School of Medicine

location_facility: Centro Peninsular de Investigación Clínica

location_facility: Centre for Rheumatology Immunology and Arthritis

location_facility: Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

location_facility: Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: The Oklahoma Center for Arthritis Therapy and Research Inc

location_facility: Multiprofile Hospital for Active Treatment Trimontium OOD

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Medical Centre Synexus Sofia EOOD - Branch Stara Zagora

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Morales Vargas Centro de Investigacion SC

location_facility: Trinity Universal Research Associates, Inc

location_facility: University of Maryland School of Medicine Division of Rheumatology

location_facility: Penn State Milton South Hershey Medical Center

location_facility: University Multiprofile Hospital for Active Treatment - Kaspela EOOD

location_facility: Centro Hospitalar do Porto EPE - Hospital de Santo Antonio

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Articularis Healthcare Group Inc dba Low Country Rheumatology

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Stanford University Hospitals and Clinics

location_facility: Southwest Florida Clinical Research Center

location_facility: Fundacion Respirar - Centro Medico Dra De Salvo

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: Shared Health Inc. operating the Health Sciences Centre Winnipeg

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Centro Hospitalar Universtario de Sao Joao, EPE

location_facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc

location_facility: Feinstein Institute for Medical Research

location_facility: Groupe de recherche en maladies osseuses Incorporated

location_facility: Centro Mexicano de Desarrollo de Estudios Clinicos

location_facility: Limited liability company Scientific Research Medical Complex Your Health

location_facility: Tomed Tomasz Miszalski-Jamka Centrum Medyczne

location_facility: New York University Langone Orthopedic Center

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil

location_facility: 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Arthritis and Rheumatology Center of Oklahoma PLLC

location_facility: State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: FSBSI SRI of Rheumatology na V A Nasonova


primary_purpose: Prevention

acronym: POLAR-A

title: A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in the Adjuvant Treatment of Patients With Stage III or High-risk Stage II Colorectal Cancer

lead_sponsor: Egetis Therapeutics

ReferenceCitation: Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.

location_country:
Taiwan
Spain
Italy
United Kingdom
Korea, Republic of
France
Belgium
Japan
Germany
Czechia

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hôpital Nord Franche-Comté Site du Mittan

location_facility: National Hospital Organization Osaka National Hospital

location_facility: St. Marianna University School of Medicine Hospital

location_facility: KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Mid Essex Hospital Services NHS Trust - Broomfield Hospital

location_facility: Onkodok GmbH / Onkologische Schwerpunktpraxis

location_facility: Centre Hospitalier Départemental de Vendée - Unité de recherche clinique

location_facility: Seoul National University Bundang Hospital

summary: This study is to evaluate PledOx for prevention of chronic chemotherapy induced peripheral neuropathy induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).


title: A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

location_country:
Poland
Taiwan
Brazil
Romania
Spain
United Kingdom
Austria
Australia
New Zealand
Argentina
Canada
Russian Federation
Ukraine
Korea, Republic of
United States
France
Turkey
Mexico
Japan
Germany

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 1301)

location_facility: Townsville General Hospital ( Site 1202)

location_facility: Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)

location_facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)

location_facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2218)

location_facility: Hopital d'Instruction des Armees Begin ( Site 1413)

location_facility: MI Odessa Regional Oncological Centre ( Site 2222)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)

location_facility: Hospital Italiano Regional del Sur ( Site 0509)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1572)

location_facility: Clínica Universitaria Reina Fabiola ( Site 0505)

location_facility: National Cheng Kung University Hospital ( Site 0905)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2219)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)

location_facility: InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)

location_facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2224)

location_facility: Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)

location_facility: Ege Universitesi Tip Fakultesi ( Site 2109)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0805)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 1003)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1559)

location_facility: Columbus Regional Research Institute ( Site 0099)

location_facility: National Cancer Center Hospital East ( Site 0801)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0046)

location_facility: Osaka International Cancer Institute ( Site 0809)

location_facility: Disney Family Cancer Center ( Site 0005)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)

location_facility: Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)

location_facility: Niigata Cancer Center Hospital ( Site 0808)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0800)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2225)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)

location_facility: Southern Medical Day Care Centre ( Site 1200)

location_facility: Aichi Cancer Center Hospital ( Site 0803)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: MidCentral DHB Palmerston North Hospital ( Site 1102)

location_facility: Universitaetsklinikum Regensburg ( Site 1562)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)

location_facility: Colchester General Hospital ( Site 1911)

location_facility: Hopital Cite de la Sante de Laval ( Site 0105)

location_facility: West Suffolk Hospitals NHS Trust ( Site 1919)

location_facility: Hospital Sant Creu i Sant Pau ( Site 1711)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0254)

location_facility: MedStar Franklin Square Medical Center ( Site 0044)

location_facility: Central City Clinical Hospital ( Site 2221)

location_facility: Kingston Health Sciences Centre ( Site 0102)

location_facility: Birmingham Heartlands Hospital ( Site 1910)

location_facility: Alabama Oncology Bruno Cancer Center ( Site 0001)

location_facility: Institut De Cancerologie De Lorraine ( Site 1409)

location_facility: Moscow Regional Oncological Dispensary ( Site 2028)

location_facility: National Taiwan University Hospital ( Site 0900)

location_facility: City Clinical Hosp.4 of DCC ( Site 2215)

location_facility: Boca Raton Regional Hospital ( Site 0018)

location_facility: Severance Hospital Yonsei University Health System ( Site 1001)

location_facility: Medical Center Asklepion LLC ( Site 2243)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0806)

location_facility: Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)

location_facility: Western General Hospital, Edinburgh ( Site 1924)

location_facility: Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

location_facility: Complejo Hospitalario de Jaen ( Site 1713)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1101)

location_facility: Hospital Britanico de Buenos Aires ( Site 0500)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

location_facility: Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)

location_facility: Mount Sinai Hospital Medical Center ( Site 0035)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

location_facility: Nova Scotia Health Authority ( Site 0103)

location_facility: Hospital Universitario 12 de Octubre ( Site 1716)

location_facility: Okayama University Hospital ( Site 0810)

location_facility: Korea University Guro Hospital ( Site 1008)

location_facility: Centre Hospitalier De Chauny ( Site 1411)

location_facility: CLIMERS Clinical Medical Research ( Site 0306)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)

location_facility: Southend University Hospital NHS Foundation Trust ( Site 1913)

location_facility: Hospital Italiano de Buenos Aires ( Site 0511)

location_facility: Studienzentrum Aschaffenburg ( Site 1575)

location_facility: Universitaetsklinikum Frankfurt ( Site 1563)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

location_facility: Sanatorio Privado San Geronimo S.R.L ( Site 0510)

location_facility: Instituto Medico Rio Cuarto ( Site 0501)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)

location_facility: China Medical University Hospital ( Site 0904)

location_facility: Kansai Medical University Hospital ( Site 0804)

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

location_facility: Gyeongsang National University Hospital ( Site 1005)

location_facility: Centro Oncológico de Rosario ( Site 0507)

location_facility: Axis Heilsa S. de R.L. de C.V. ( Site 0301)

location_facility: Chelsea and Westminster Hospital ( Site 1901)

location_facility: SPb Central Clinical Railway Hospital ( Site 2003)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0263)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

location_facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

location_facility: Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)

location_facility: Instituto do Cancer do Ceara ( Site 0251)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)

location_facility: Waverly Hematology Oncology ( Site 0054)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)

location_facility: Chungbuk National University Hospital ( Site 1002)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)

location_facility: Complejo Hospitalario de Malaga ( Site 1714)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 2104)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 0053)

location_facility: Helios Klinikum Erfurt GmbH ( Site 1552)

location_facility: Hospital Universitario Virgen Macarena ( Site 1712)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)

location_facility: Stronach Regional Cancer Centre ( Site 0100)

location_facility: Thompson Cancer Survival Center ( Site 2812)

location_facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)

location_facility: CISSS de la Monteregie-Centre ( Site 0101)

location_facility: Universitaetsmedizin Goettingen ( Site 1557)

location_facility: Kanazawa University Hospital ( Site 0811)

summary:
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:

Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).


title: A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer

location_country:
Poland
Taiwan
Brazil
Romania
Spain
United Kingdom
Austria
Australia
New Zealand
Argentina
Canada
Russian Federation
Ukraine
Korea, Republic of
United States
France
Turkey
Colombia
Japan
Germany

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 1301)

location_facility: Townsville General Hospital ( Site 1202)

location_facility: Universitaetsmedizin Goettingen ( Site 1507)

location_facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)

location_facility: Hopital d'Instruction des Armees Begin ( Site 1413)

location_facility: Saint Gallen Instituto de Oncologia ( Site 0206)

location_facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)

location_facility: Hospital Italiano Regional del Sur ( Site 0509)

location_facility: Universitaetsklinikum Frankfurt ( Site 1513)

location_facility: Clínica Universitaria Reina Fabiola ( Site 0505)

location_facility: Stronach Regional Cancer Centre ( Site 0101)

location_facility: National Cheng Kung University Hospital ( Site 0905)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2205)

location_facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)

location_facility: Ege Universitesi Tip Fakultesi ( Site 2109)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)

location_facility: Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0805)

location_facility: Administradora Country S.A. ( Site 0603)

location_facility: Hospital Universitario Quiron Madrid ( Site 1701)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)

location_facility: Mount Sinai Hospital Medical Center ( Site 0032)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0204)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 1003)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)

location_facility: Waverly Hematology Oncology ( Site 0081)

location_facility: Hospital Clinico Universitario de Valencia ( Site 1706)

location_facility: National Cancer Center Hospital East ( Site 0801)

location_facility: Central City Clinical Hospital ( Site 2207)

location_facility: Osaka International Cancer Institute ( Site 0809)

location_facility: Disney Family Cancer Center ( Site 0005)

location_facility: City Clinical Hosp.4 of DCC ( Site 2201)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)

location_facility: Niigata Cancer Center Hospital ( Site 0808)

location_facility: Columbus Regional Research Institute ( Site 0098)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0800)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)

location_facility: Southern Medical Day Care Centre ( Site 1200)

location_facility: Aichi Cancer Center Hospital ( Site 0803)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)

location_facility: Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)

location_facility: Helios Klinikum Erfurt GmbH ( Site 1502)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: MidCentral DHB Palmerston North Hospital ( Site 1102)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)

location_facility: Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2106)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)

location_facility: Colchester General Hospital ( Site 1911)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)

location_facility: West Suffolk Hospitals NHS Trust ( Site 1919)

location_facility: Universitaetsklinikum Regensburg ( Site 1512)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0041)

location_facility: InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0060)

location_facility: Birmingham Heartlands Hospital ( Site 1910)

location_facility: Alabama Oncology Bruno Cancer Center ( Site 0001)

location_facility: Institut De Cancerologie De Lorraine ( Site 1409)

location_facility: Moscow Regional Oncological Dispensary ( Site 2028)

location_facility: National Taiwan University Hospital ( Site 0900)

location_facility: Boca Raton Regional Hospital ( Site 0018)

location_facility: Health Sciences North Research Institute ( Site 0115)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0806)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0207)

location_facility: Western General Hospital, Edinburgh ( Site 1924)

location_facility: Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)

location_facility: Hospital Universitario Nuestra Senora de Valme ( Site 1703)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 0046)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1101)

location_facility: Hospital Britanico de Buenos Aires ( Site 0500)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0903)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2204)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0107)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)

location_facility: Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 1522)

location_facility: Okayama University Hospital ( Site 0810)

location_facility: Centre Hospitalier De Chauny ( Site 1411)

location_facility: Korea University Guro Hospital ( Site 1008)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2210)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)

location_facility: Hospital Italiano de Buenos Aires ( Site 0511)

location_facility: MI Odessa Regional Oncological Centre ( Site 2208)

location_facility: Medstar Good Samaritan Hospital ( Site 0040)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)

location_facility: Sanatorio Privado San Geronimo S.R.L ( Site 0510)

location_facility: Instituto Medico Rio Cuarto ( Site 0501)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)

location_facility: Hospital Clinico Lozano Blesa ( Site 1700)

location_facility: China Medical University Hospital ( Site 0904)

location_facility: Kansai Medical University Hospital ( Site 0804)

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)

location_facility: Gyeongsang National University Hospital ( Site 1005)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1509)

location_facility: Chelsea and Westminster Hospital ( Site 1901)

location_facility: SPb Central Clinical Railway Hospital ( Site 2003)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 2001)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)

location_facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)

location_facility: CISSS de la Monteregie-Centre ( Site 0114)

location_facility: Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0214)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)

location_facility: Studienzentrum Aschaffenburg ( Site 1525)

location_facility: Instituto do Cancer do Ceara ( Site 0201)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)

location_facility: Chungbuk National University Hospital ( Site 1002)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)

location_facility: Medical Center Asklepion LLC ( Site 2234)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2211)

location_facility: Northwest Alabama Cancer Center, PC ( Site 0002)

location_facility: Centro de Hematologia e Oncologia ( Site 0205)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)

location_facility: Centro Oncológico de Rosario ( Site 0507)

summary: The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).


title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache

summary: Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in subjects with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Poland
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Finland
Hungary
United States
France
Czechia

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Hospital Clinico Universitario de Valencia

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria

location_facility: Fondazione Istituto Neurologico Nazionale C Mondino IRCCS

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: The George Washington Medical Faculty Associates

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Allegheny Health Network Cancer Institute at Mellon Pavilion

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna

location_facility: Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: University of Miami Miller School of Medicine

location_facility: Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Centre Hospitalier Universitaire de Nice - Hopital de Cimiez

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

location_facility: Konventhospital der Barmherzigen Brueder Linz

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Michigan Head Pain and Neurological Institute

location_facility: Clinical Trial Investigator Clinical Research Center

location_facility: Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord


title: A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation

lead_sponsor: AbbVie

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.

location_country:
Poland
Romania
Serbia
Spain
United Kingdom
New Zealand
Canada
Hungary
France
United States
Belgium
Netherlands
Slovakia
Czechia

location_facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 227815

location_facility: Belfast Health and Social Care Trust /ID# 212502

location_facility: Universitair Medisch Centrum Utrecht /ID# 212935

location_facility: CHU Nantes - Hopital Laennec /ID# 212897

location_facility: Vanderbilt University Medical Center /ID# 212353

location_facility: Nationwide Childrens Hospital /ID# 213158

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213146

location_facility: Royal Papworth Hospital NHS Foundation Trust /ID# 212507

location_facility: Universitair Ziekenhuis Leuven /ID# 213050

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 212856

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 212665

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université L /ID# 212655

location_facility: Unity Health Toronto - St. Michael's Hospital /ID# 212552

location_facility: Royal University Hospital - CTSU /ID# 228188

location_facility: Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić" /ID# 212820

location_facility: CHU de Reims - Hôpital Maison Blanche /ID# 212910

location_facility: Manchester University NHS Foundation Trust /ID# 213058

location_facility: QEII - Health Sciences Centre /ID# 212656

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 213596

location_facility: Cardiff & Vale University Health Board /ID# 212504

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust /ID# 212291

location_facility: University of Iowa Hospitals and Clinics /ID# 212351

location_facility: Royal Brompton and Harefield Hospitals /ID# 212490

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 212491

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 212862

location_facility: Cardinal Glennon Children's Hospital /ID# 212349

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 212493

location_facility: Nottingham University Hospitals NHS Trust /ID# 212531

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 212898

location_facility: Washington University-School of Medicine /ID# 212352

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 213413

location_facility: McGill University Health Center Research Institute /ID# 212553

location_facility: Hospital Universitario Vall d'Hebron /ID# 213014

location_facility: Hospital Universitario La Paz /ID# 213513

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 212289

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 213494

location_facility: Medical University of South Carolina /ID# 212187

summary: This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.


title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

summary: The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.

ReferenceCitation: Domachowske J, Madhi SA, Simões EAF, Atanasova V, Cabañas F, Furuno K, Garcia-Garcia ML, Grantina I, Nguyen KA, Brooks D, Chang Y, Leach A, Takas T, Yuan Y, Griffin MP, Mankad VS, Villafana T; MEDLEY Study Group. Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity. N Engl J Med. 2022 Mar 3;386(9):892-894. doi: 10.1056/NEJMc2112186.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
South Africa
Belgium
Japan
Czechia
Poland
Austria
Russian Federation
Turkey
Mexico
Sweden
Canada
Hungary
Germany
Bulgaria
Latvia
Estonia
New Zealand
Finland
Korea, Republic of
France


title: A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

summary: This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: F Smit E, Dooms C, Raskin J, Nadal E, Tho LM, Le X, Mazieres J, S Hin H, Morise M, W Zhu V, Tan D, H Holmberg K, Ellers-Lenz B, Adrian S, Brutlach S, Schumacher KM, Karachaliou N, Wu YL. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance. Future Oncol. 2022 Mar;18(9):1039-1054. doi: 10.2217/fon-2021-1406. Epub 2021 Dec 17.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Netherlands
Thailand
Vietnam
Korea, Republic of
United States
France
China
Malaysia
Belgium
Japan
Germany
Singapore

location_facility: Queen Elizabeth Hospital - Department of Medicine

location_facility: Centre Francois Baclesse - Service d'Oncologie Medicale

location_facility: Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine

location_facility: NYU Langone Clinical Cancer Center - NYU Langone Medical Center

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Chonnam National University Hwasun Hospital

location_facility: Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie

location_facility: University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology

location_facility: Hospital Pulau Pinang - Clinic Respiratory

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Boston Medical Center - Dept. Hematology/Oncology

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university

location_facility: Hospital Universitari Son Espases - Servicio de Oncologia Medica

location_facility: Compassionate Care Research Group Inc - Edinger Medical Group, Inc.

location_facility: Weill Cornell Medical College - Gastroenterology

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Eastern Connecticut Hematology & Oncology Associates

location_facility: The Center for Cancer & Blood Disorders - Maryland

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Nagoya University Hospital - Dept of Respiratory Medicine

location_facility: The Chinese University of Hong Kong - Emergency Medicine

location_facility: AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II

location_facility: New Jersey Cancer Care and Blood Disorders

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: Kanagawa Cancer Center - Dept of Respiratory Medicine

location_facility: Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: National Cancer Centre - Medical Oncology Pharmacy

location_facility: Niigata Cancer Center Hospital - Dept of Internal Medicine

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

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

location_facility: Hospital Universitari Dexeus - Servicio de Oncologia Medica

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia

location_facility: CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

location_facility: Frederick Health- James M Stockman Cancer Institute

location_facility: Okayama University Hospital - Dept of Respiratory Medicine/Allergy

location_facility: Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie

location_facility: Ventura County Hematology Oncology Specialists

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Beacon International Specialist Centre Sdn Bhd

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

location_facility: Seoul National University Bundang Hospital

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Universitair Medisch Centrum Groningen - Department of Internal Medicine

location_facility: Hospital Regional Universitario de Malaga

location_facility: University of Miami Miller School of Medicine

location_facility: Sparrow Hospital Herbert - Herman Cancer Center

location_facility: SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"

location_facility: Maastricht University Medical Center - Dept of Medical Oncology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica

location_facility: Hyogo College of Medicine Hospital - Dept of Respiratory Medicine

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée

location_facility: Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie

location_facility: Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) - Oncologia Medica

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

location_facility: Hospital Cochin Service, Service de Pneumologie et Mucoviscidose

location_facility: Tan Tock Seng Hospital - CTRU/OCS, Research

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia

location_facility: Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia

location_facility: Medstar Franklin Square Clinical Research Center