title: A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

summary: This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

ReferenceCitation: Kelley RK, Rimassa L, Cheng AL, Kaseb A, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Banerjee K, Hazra S, Fawcett J, Yau T. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):995-1008. doi: 10.1016/S1470-2045(22)00326-6. Epub 2022 Jul 4.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

ReferenceCitation: Kelley RK, W Oliver J, Hazra S, Benzaghou F, Yau T, Cheng AL, Rimassa L. Cabozantinib in combination with atezolizumab versus sorafenib in treatment-naive advanced hepatocellular carcinoma: COSMIC-312 Phase III study design. Future Oncol. 2020 Jul;16(21):1525-1536. doi: 10.2217/fon-2020-0283. Epub 2020 Jun 3.

publisher_dissemination: Future Science Ltd

lead_sponsor: Exelixis

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Turkey
Czechia
Canada
France
Colombia
Hungary
Hong Kong
Switzerland
United States
Ukraine
Romania
Belgium
China
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Georgia
Russian Federation
Israel

location_facility:
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study_start_date_type: Actual

intervention_type: Drug

acronym: Phase III study of pembrolizumab for high-risk early-stage ER+/HER2– breast cancer

lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

location_facility: National Taiwan University Hospital ( Site 2404)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 0405)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903)

location_facility: Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2907)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1505)

location_facility: Imelda Ziekenhuis Bonheiden ( Site 0703)

location_facility: CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)

location_facility: Peter MacCallum Cancer Centre ( Site 2102)

location_facility: MGH - North Shore Cancer Center ( Site 0081)

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0406)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)

location_facility: Massachusetts General Hospital ( Site 0024)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0208)

location_facility: Canterbury Regional Cancer & Blood Services ( Site 2303)

location_facility: Severance Hospital Yonsei University Health System ( Site 2201)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2707)

location_facility: Zhejiang Provincial People's Hospital ( Site 3225)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)

location_facility: Hospital Universitario 12 de Octubre ( Site 1356)

location_facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1013)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)

location_facility: OHSU Knight Cancer Institute ( Site 0051)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 1503)

location_facility: Texas Oncology-Memorial City ( Site 8012)

location_facility: Chaim Sheba Medical Center. ( Site 1707)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1901)

location_facility: Hospital Ruber Internacional ( Site 1370)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)

location_facility: UZ Antwerpen - Medical Oncology ( Site 0709)

location_facility: Hospital Clinico San Carlos ( Site 1354)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 1907)

location_facility: Texas Oncology-Austin Central ( Site 8004)

location_facility: Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 3216)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)

location_facility: Hospital Clinic I Provincial de Barcelona ( Site 1353)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 3203)

location_facility: Southeastern Regional Medical Center, Inc. ( Site 0075)

location_facility: Orchard Healthcare Research Inc. ( Site 0020)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2603)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1360)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2716)

location_facility: Weill Cornell Medical College ( Site 0043)

location_facility: Centre Georges Francois Leclerc ( Site 0920)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0917)

location_facility: Midwestern Regional Medical Center, Inc. ( Site 0077)

location_facility: National Cheng Kung University Hospital ( Site 2400)

location_facility: Sana Klinikum Offenbach GmbH ( Site 1002)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0083)

location_facility: MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)

location_facility: Complejo Hospitalario de Jaen ( Site 1364)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 2301)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1905)

location_facility: Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)

location_facility: MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0073)

location_facility: Instituto Nacional de Cancer - INCA HC III ( Site 0200)

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

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)

location_facility: Shaare Zedek Medical Center ( Site 1708)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1008)

location_facility: MI Odesa Regional Clinical Hospital ( Site 2701)

location_facility: CHU UCL Namur Site de Godinne ( Site 0706)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)

location_facility: Ryazan Regional Clinical Oncology Dispensary ( Site 1910)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 2607)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 1705)

location_facility: Medizinische Management GmbH ( Site 1012)

location_facility: Saitama Medical University International Medical Center ( Site 2606)

location_facility: Nottingham University Hospitals NHS Trust ( Site 1504)

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)

location_facility: Medical Rehabilitation Center ( Site 1912)

location_facility: The First Hospital of Jilin University ( Site 3201)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702)

location_facility: MI Odessa Regional Oncological Centre ( Site 2714)

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)

location_facility: Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)

location_facility: Hospital Metropolitano - Sede Lindora ( Site 4203)

location_facility: Virginia Oncology Associates ( Site 8001)

location_facility: National Cancer Center Hospital East ( Site 2613)

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)

location_facility: Kadlec Clinic Hematology and Oncology ( Site 0070)

location_facility: Fukushima Medical University Hospital ( Site 2610)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1803)

location_facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)

location_facility: Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)

location_facility: MercyOne Waterloo Cancer Center ( Site 0016)

location_facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1820)

location_facility: Zhejiang Cancer Hospital.... ( Site 3210)

location_facility: Hyogo College of Medicine Hospital ( Site 2600)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)

location_facility: El Camino Hospital Cancer Center ( Site 0004)

location_facility: Associacao Hospitalar Moinhos de Vento ( Site 0201)

location_facility: Maryland Oncology Hematology, P.A. ( Site 8007)

location_facility: Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0903)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1367)

location_facility: Bialostockie Centrum Onkologii ( Site 1819)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 8008)

location_facility: The University of Chicago Medical Center ( Site 0080)

location_facility: Harbin Medical University Cancer Hospital ( Site 3200)

location_facility: Orszagos Onkologiai Intezet ( Site 2908)

location_facility: Aichi Cancer Center Hospital ( Site 2601)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)

location_facility: Instytut Centrum Zdrowia Matki Polki ( Site 1821)

location_facility: Fudan University Shanghai Cancer Center ( Site 3205)

location_facility: Baptist MD Anderson Cancer Center ( Site 0014)

location_facility: Fundacion Universitaria Sanitas ( Site 0403)

location_facility: Kitasato University Hospital ( Site 2616)

location_facility: Hospital Teresa Herrera - Chuac ( Site 1358)

location_facility: Goshen Center for Cancer Care ( Site 0021)

location_facility: Hospital General Arnau de Vilanova de Valencia ( Site 1369)

location_facility: Khmelnitskiy Regional Onkology Dispensary ( Site 2704)

location_facility: Medical University of South Carolina ( Site 0053)

location_facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)

location_facility: CISSS de la Monteregie-Centre ( Site 0108)

location_facility: University of Colorado Cancer Center ( Site 0008)

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)

location_facility: Kumamoto University Hospital ( Site 2602)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)

location_facility: Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2402)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0925)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)

location_facility: St. Vincent Frontier Cancer Center ( Site 0033)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8000)

location_facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2611)

location_facility: Mayo Clinic and Medical School (Rochester) ( Site 0029)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1818)

location_facility: UPR Comprehensive Cancer Center ( Site 6200)

location_facility: Colchester General Hospital ( Site 1508)

location_facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)

location_facility: James Graham Brown Cancer Center ( Site 0022)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)

location_facility: Universitaetsklinikum Erlangen ( Site 1001)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219)

location_facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)

location_facility: Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3209)

location_facility: Centro de Investigacion Clinica del Country ( Site 0402)

location_facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0701)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2719)

location_facility: Seoul National University Hospital ( Site 2200)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)

location_facility: Hospital Clinico Universitario de Valencia ( Site 1355)

location_facility: Princess Margaret Cancer Centre ( Site 0112)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2604)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 2720)

location_facility: Hospital Geral de Santo Antonio ( Site 2503)

location_facility: China Medical University Hospital ( Site 2401)

status: Active, not recruiting

title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)

primary_purpose: Treatment

type: Other Identifier

type: Registry Identifier

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Costa Rica
Japan
Canada
France
Colombia
Portugal
Hungary
United States
Ukraine
Belgium
China
Puerto Rico
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer

acronym: Appalaches

summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

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

collaborators: Swedish Association of Breast Oncologists

collaborators: Gruppo Oncologico Italiano di Ricerca Clinica

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Belgium
Spain
Jordan
France

location_facility: Onkologie Haematologie Gemeinschaftspraxis - Studienzentrum Onkologie Ravensburg

location_facility: Riccione Hospital Unit - Ospedale Cervesi di Cattolica

location_facility: Barts Health NHS Trust - St. Bartholomew'S Hospital

location_facility: Fundacion Instituto Valenciano De Oncologia

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna

location_facility: Hospital prive du Confluent - Centre Catherine de Sienne

location_facility: Institut Jules Bordet-Hopital Universitaire ULB

location_facility: Instituto Portugues De Oncologia - Instituto Portugues de Oncologia do Porto

location_facility: Rimini Hospital Unit - Ospedale Sacra Famiglia

location_facility: Faenza Hospital Unit - Ospedale degli Infermi

location_facility: NHS Borders - Borders General Hospital Melrose By-pass

location_facility: AUSL Romagna - Rimini Hospital Unit - Infermi Hospital

location_facility: CHU de Lyon - Hopital De La Croix Rousse

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

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool Victoria Hospital-NHS Fundation Trust

location_facility: Azienda Ospedaliero Universitaria - Ospedali Riuniti

location_facility: ORTENAU KLINIKUM Offenburg-Gengenbach - Klinikum Offenburg Ebertplatz

location_facility: AULSS 9 - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska - Curie's National Institute of Oncology - National Research Institute

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" - IRCCS - AUO San Martino - IST


title: An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

summary: The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Blauvelt A, Langley RG, Lacour JP, Toth D, Laquer V, Beissert S, Wollenberg A, Herranz P, Pink AE, Peris K, Fangel S, Gjerum L, Corriveau J, Saeki H, Warren RB, Simpson E, Reich K. Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial. J Am Acad Dermatol. 2022 Oct;87(4):815-824. doi: 10.1016/j.jaad.2022.07.019. Epub 2022 Jul 19.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Belgium
United States
Spain
Czechia
Canada
France

location_facility:
LEO Pharma Investigational Site 2
LEO Pharma Investigational Site
LEO Pharma Investigational Site 1


title: Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status

summary:
As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study.

The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Curran D, Kim JH, Matthews S, Dessart C, Levin MJ, Oostvogels L, Riley ME, Schmader KE, Cunningham AL, McNeil SA, Schuind AE, Andrew MK; Zoster-064 Study Group. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. J Am Geriatr Soc. 2021 Mar;69(3):744-752. doi: 10.1111/jgs.16917. Epub 2020 Nov 16.

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Wiley

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Italy
United Kingdom
Hong Kong
Australia
Brazil
Japan
Mexico
Sweden
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Estonia
France

intervention_type: Other

status_simplified: Completed


summary:
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

ReferenceCitation: Long GV, Luke JJ, Khattak MA, de la Cruz Merino L, Del Vecchio M, Rutkowski P, Spagnolo F, Mackiewicz J, Chiarion-Sileni V, Kirkwood JM, Robert C, Grob JJ, de Galitiis F, Schadendorf D, Carlino MS, Mohr P, Dummer R, Gershenwald JE, Yoon CH, Wu XL, Fukunaga-Kalabis M, Krepler C, Eggermont AMM, Ascierto PA; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in resected stage IIB or IIC melanoma (KEYNOTE-716): distant metastasis-free survival results of a multicentre, double-blind, randomised, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1378-1388. doi: 10.1016/S1470-2045(22)00559-9. Epub 2022 Oct 18.

oa_host_type: closed

ReferenceCitation: Luke JJ, Rutkowski P, Queirolo P, Del Vecchio M, Mackiewicz J, Chiarion-Sileni V, de la Cruz Merino L, Khattak MA, Schadendorf D, Long GV, Ascierto PA, Mandala M, De Galitiis F, Haydon A, Dummer R, Grob JJ, Robert C, Carlino MS, Mohr P, Poklepovic A, Sondak VK, Scolyer RA, Kirkwood JM, Chen K, Diede SJ, Ahsan S, Ibrahim N, Eggermont AMM; KEYNOTE-716 Investigators. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022 Apr 30;399(10336):1718-1729. doi: 10.1016/S0140-6736(22)00562-1. Epub 2022 Apr 1.

ReferenceCitation: Luke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

location_facility: University of Tennessee Medical Center Knoxville ( Site 0116)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0657)

location_facility: Melanoma Institute Australia ( Site 0856)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)

location_facility: Massachusetts General Hospital ( Site 0126)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)

location_facility: UPMC Hillman Cancer Centers ( Site 0043)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0142)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0454)

location_facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)

location_facility: Centro Oncologico Antofagasta ( Site 0206)

location_facility: Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)

location_facility: John Wayne Cancer Institute ( Site 0026)

location_facility: McGill University Health Centre ( Site 0062)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0251)

location_facility: Ashford Cancer Centre Research ( Site 0860)

location_facility: IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0807)

location_facility: Klinikum der Universitaet in Wuerzburg ( Site 0356)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)

location_facility: Addenbrooke's Hospital in Cambridge ( Site 0600)

location_facility: Mayo Clinic [Rochester, MN] ( Site 0016)

location_facility: Universitaetsklinikum in Mannheim ( Site 0351)

location_facility: Hospital Sao Vicente de Paulo ( Site 0158)

location_facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)

location_facility: Moffitt McKinley Outpatient Center ( Site 0131)

location_facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0200)

location_facility: Instituto Nacional do Cancer II ( Site 0160)

location_facility: West Cancer Center - East Campus ( Site 0022)

location_facility: IRCCS A.O.U. San Martino - IST ( Site 0404)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)

location_facility: Hospital de Clinicas de Rio Preto ( Site 0162)

location_facility: Hospital Universitario Virgen Macarena ( Site 0455)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0301)

location_facility: Dana Farber Cancer Institute ( Site 0124)

location_facility: Hospital de Caridade de Ijui ( Site 0156)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0055)

location_facility: Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 0556)

location_facility: Hospital General Universitario de Valencia ( Site 0451)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0456)

location_facility: The University of Chicago Medical Center ( Site 0007)

location_facility: Universitaetsspital Zuerich ( Site 0551)

location_facility: Chaim Sheba Medical Center. ( Site 0652)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0306)

location_facility: Winship Cancer Institute of Emory University ( Site 0046)

location_facility: Centre Hospitalier Universitaire Vaudois ( Site 0553)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 0601)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0316)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0203)

location_facility: Hospital Clinic de Barcelona ( Site 0452)

location_facility: Oncological Institute of Southern Switzerland ( Site 0557)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0201)

location_facility: University of Arizona Cancer Center ( Site 0121)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0612)

location_facility: Beth Israel Deaconess Medical Center ( Site 0141)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 0137)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0770)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)

location_facility: Hopital Maisonneuve Rosemont ( Site 0056)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0030)

location_facility: National Cancer Center Hospital ( Site 0910)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0651)

location_facility: Royal Marsden Hospital - Fulham Road London ( Site 0613)

location_facility: Seattle Cancer Care Alliance ( Site 0044)

location_facility: Azienda Ospedaliero Universitaria Senese ( Site 0401)

location_facility: University of Iowa Hospital and Clinics ( Site 0001)

location_facility: Advocate Medical Group-Park Ridge ( Site 0025)

location_facility: Oregon Health & Science University ( Site 0032)

location_facility: Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)

location_facility: Christie NHS Foundation Trust ( Site 0604)

location_facility: Inova Schar Cancer Institute ( Site 0014)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)

location_facility: CHU Amiens Picardie Hopital Nord ( Site 0317)

location_facility: Princess Margaret Cancer Centre ( Site 0059)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0407)

location_facility: Princess Alexandra Hospital ( Site 0857)

location_facility: University of Colorado Cancer Center ( Site 0027)

location_facility: Medizinische Hochschule Hannover ( Site 0358)

location_facility: Children's Hospital of Pittsburgh UPMC ( Site 0144)

location_facility: Sunnybrook Research Institute ( Site 0060)

location_facility: Universitaetsklinikum Tuebingen ( Site 0353)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0304)

location_facility: The Angeles Clinic and Research Institute ( Site 0029)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0360)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0134)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0801)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 0207)

location_facility: Tasman Oncology Research Pty Ltd ( Site 0858)

location_facility: Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)

title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Japan
Switzerland
Belgium
United States
Spain
South Africa
Chile
Canada
France


title: An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

summary:
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

ReferenceCitation: Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12.

oa_colors: green other

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Germany
Argentina
Australia
Japan
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: White Plains Hospital Center for Cancer Care - Oncology Site

location_facility: UCI Chao Family Comprehensive Cancer Center

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Benaroya Research Institute at Virginia Mason


acronym: NAVIGATOR

lead_sponsor: AstraZeneca

summary: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

ReferenceCitation: Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist A, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL

ReferenceCitation: Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist A, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

sponsor_collaborators: AstraZeneca Amgen

title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Israel
Argentina
United Kingdom
Australia
Brazil
Japan
Austria
United States
Korea, Republic of
Saudi Arabia
Vietnam
South Africa
Taiwan
Canada
Ukraine
Russian Federation
France


acronym: HIMALAYA

summary: This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

title: A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

location_country:
Germany
Italy
India
Hong Kong
Japan
Brazil
United States
China
Korea, Republic of
Spain
Thailand
Vietnam
Taiwan
Canada
Ukraine
Russian Federation
France


title: A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

summary: The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

ReferenceType: result

ReferenceCitation: Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36. doi: 10.1016/s0149-2918(04)90072-0.

ipd_sharing_description: According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Ireland
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Belgium
France


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

acronym: AGILE

summary: Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

ReferenceCitation: Montesinos P, Recher C, Vives S, Zarzycka E, Wang J, Bertani G, Heuser M, Calado RT, Schuh AC, Yeh SP, Daigle SR, Hui J, Pandya SS, Gianolio DA, de Botton S, Dohner H. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. N Engl J Med. 2022 Apr 21;386(16):1519-1531. doi: 10.1056/NEJMoa2117344.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

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

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Centre Hospitalier de Versailles CHV Hopital Andre Mignot

location_facility: Unicamp Universidade Estadual de Campinas

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

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

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Severance Hospital Yonsei University Health System

location_facility: Institut dHematologie de Basse Normandie

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino


lead_sponsor: Hoffmann-La Roche

summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

location_facility: Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Northwestern University; Robert H. Lurie Comp Can Ctr

location_facility: HonorHealth Research Institute ? Bisgrove

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Clinic for Pulmonology, Clinical Center of Serbia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: US oncology research at Minnesota Oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Centre Leon Berard; Departement Oncologie Medicale

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

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

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

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Rocky Mountain Cancer Ctr - Denver (Williams)

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

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

location_facility: Changhua Christian Hospital; Internal Medicine

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Sunnybrook Odette Cancer Centre; Clinical Trials

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

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

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Lakeridge Health Corporation-Oshawa; Oncology clinic

location_facility: China Medical University Hospital; Urology

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Iwate Medical University Hospital; Urology

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Northwest Cancer Specialists - Portland (N Broadway)

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Beth Israel Medical Center; Division of Digestive Diseases

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Royal Free Hospital; Oncology & Haematology

location_facility: Kaiser Permanente - San Diego (Zion Ave)

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Centre Medico-Chirurgical Foch; Service de Pneumologie

location_facility: Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

location_facility: Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

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

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

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

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

title: An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

design_allocation: Non-Randomized

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
Serbia
France
Slovenia
Portugal
Hungary
Switzerland
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


acronym: ECZTRA 1

summary:
Primary objective:

To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.

Maintenance objective:

To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.

ReferenceCitation: Blauvelt A, Gooderham M, Bhatia N, Langley RG, Schneider S, Zoidis J, Kurbasic A, Armstrong A, Silverberg JI. Tralokinumab Efficacy and Safety, with or without Topical Corticosteroids, in North American Adults with Moderate-to-Severe Atopic Dermatitis: A Subanalysis of Phase 3 Trials ECZTRA 1, 2, and 3. Dermatol Ther (Heidelb). 2022 Nov;12(11):2499-2516. doi: 10.1007/s13555-022-00805-y. Epub 2022 Sep 24.

ReferenceCitation: Simpson EL, Merola JF, Silverberg JI, Reich K, Warren RB, Staumont-Salle D, Girolomoni G, Papp K, de Bruin-Weller M, Thyssen JP, Zachariae R, Olsen CK, Wollenberg A. Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. Br J Dermatol. 2022 Dec;187(6):888-899. doi: 10.1111/bjd.21867. Epub 2022 Oct 26.

publisher_dissemination: Oxford University Press

ReferenceCitation: Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Osterdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

location_facility: Hospital Universitario La Paz, Servicio Dermatología

location_facility: Research Institute of the Southeast, LLC

location_facility: Hospital de la Santa Creu i Sant Pau, Servicio Dermatología

location_facility: Hospital Clinic de Barcelona, Dermatology Department

location_facility: Hospital Infanta Leonor, Servicio Dermatología

location_facility: Hôpital Saint vincent de paul, Clinique de Dermatologie

location_facility: LMU München, Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord

location_facility: Hospital Universitario y Politécnico La Fe, Servicio Dermatología

location_facility: University at Buffalo Department of Dermatology

location_facility: Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie

location_facility: Center for Dermatology and Laser Surgery

location_facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum Augsburg, Klinik für Dermatologie und Allergologie

location_facility: SRH Wald-Klinikum Gera, Klinik für klinische Studien

location_facility: Hospital Germans Trias i Pujol, Servicio Dermatología

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hospital de Cruces, Servicio Dermatología

location_facility: Clínica Universitaria de Navarra, Servicio Dermatología

location_facility: Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin

location_facility: Hospital Virgen de la Macarena, Servicio Dermatología

location_facility: Klinikum Bielefeld Rosenhöhe, Hautklinik

location_facility: Niesmann, Hautzentrum im Jahrhunderthaus

location_facility: Hospital de Fuenlabrada, Servicio Dermatología

location_facility: Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie

location_facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie

location_facility: CHRU de Brest - Hôpital Morvan, Service de Dermatologie

location_facility: Dermtology Treatment and Research Center

location_facility: Hôpital Robert Debré, Service de Dermatologie

location_facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Georgia Pollens Clinical Research Centers, Inc.

location_facility: Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie

location_facility: Hospital de Basurto, Servicio Dermatología

location_facility: Hospital Universitario de la Princesa, Servicio Dermatología

location_facility: Hôpital de l'Archet II, Service de Dermatologie- Vénérologie

location_facility: Hospital Reina Sofía, Servicio Dermatología

location_facility: Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Cabinet Médical, Le Bateau Blanc-Immeuble A

location_facility: C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie

location_facility: Hôpital Claude Huriez-CHRU, Service de dermatologie

location_facility: CHU de Toulouse Hôpital Larrey, Service de Dermatologie

location_facility: Hôpital Charles Nicolle, Clinique Dermatologique

title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

location_country:
Germany
Japan
United States
Spain
France


lead_sponsor: United Therapeutics

summary: This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).

ReferenceCitation: Edelman MJ, Dvorkin M, Laktionov K, Navarro A, Juan-Vidal O, Kozlov V, Golden G, Jordan O, Deng CQ, Bentsion D, Chouaid C, Dechev H, Dowlati A, Fernandez Nunez N, Ivashchuk O, Kiladze I, Kortua T, Leighl N, Luft A, Makharadze T, Min Y, Quantin X; DISTINCT study investigators. Randomized phase 3 study of the anti-disialoganglioside antibody dinutuximab and irinotecan vs irinotecan or topotecan for second-line treatment of small cell lung cancer. Lung Cancer. 2022 Apr;166:135-142. doi: 10.1016/j.lungcan.2022.03.003. Epub 2022 Mar 4.

location_facility: Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos

location_facility: Kaiser Permanente Northwest Center for Health Research CRSS

location_facility: High Technology Medical Center, University Clinic

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo

location_facility: State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council," Municipal Institution "Multifield Dnipropetrovsk City Hospital #4" of Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: Horizon Health Network - The Moncton Hosoital

location_facility: Hospital General Universitário Gregorio Marañón

location_facility: Mid North Coast Cancer Institute Coff Habour Health Campus

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: University of Wisoncsin - Carbone Cancer Ctr

location_facility: Radiation Oncology, Campus Bio-Medico University

location_facility: Complexo Hospitalario Universitario de Ourense (CHUO)

location_facility: Emergency County Hospital Satu-Mare, Medical Oncology Clinic

location_facility: Institut Regional du Cancer de Montpellier

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary

location_facility: The University of Texas Health Science Center at Tyler, Office of Clinical Studies

location_facility: Spartanburg Medical Center/Gibbs Cancer Center and Research Institute

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

location_facility: Physicians' Clinic of Iowa Hematology and Oncology

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina

location_facility: Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad

location_facility: Department of Medicine, Faculty of Medicine

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary

location_facility: Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena

location_facility: Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation

location_facility: Mater Misericordiae Limited and Mater Medical Research Institute Limited

location_facility: Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology

location_facility: Dipartimento di Oncologia, ARNAS Garibaldi

location_facility: Ospedale Santa Maria della Misericordia, Perugia

location_facility: Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas

location_facility: Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven

location_facility: Kyungpook National University Medical Center

location_facility: State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)

location_facility: Fox Chase Cancer Center Office of Clinical Research

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Universitario Madrid Norte Sanchinarro

location_facility: Cancer Treatment Centers of America at Eastern Regional Medical Center

location_facility: Hospital Regional de Málaga (H. Carlos Haya)

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte

location_facility: Istituto Europeo di Oncologia (IEO), Milano

location_facility: State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary

location_facility: Communal Non-profit Enterprise "Kyiv City Clinical Oncology Center" of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients

location_facility: L'Institut Universitaire de Cardiologie et de pneumologie de Quebec

location_facility: Szpital Chorób Płuc im Św. Józefa w Pilchowicach

location_facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

location_facility: State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"

location_facility: Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Pusan National University Yangsan Hospital

location_facility: URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse

location_facility: Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov

location_facility: Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia

location_facility: Centrum Onkologii-Instytut im. Sklodowskiej-Curie

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály

location_facility: Eastern Connecticut Hematology and Oncology Assoc

location_facility: Cross Cancer Institute - Clinical Trials Unit

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

location_facility: Keimyung University Dongsan Medical Centre

location_facility: Koranyi National Institute of TBC and Pulmonology

location_facility: Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary

location_facility: Instituto Catalán de Oncología (ICO) - Josep Trueta

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital

location_facility: Camden Clark Medical Center / Regional Cancer Center

location_facility: LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''

location_facility: Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region

location_facility: Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary

location_facility: Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre

location_facility: Cancer Treatment Centers of America at Southwestern RMC

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich

location_facility: Institut Paoli-Calmettes, Service Dòncologie Médicale

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Cancer Treatment Centers of America - Western Regional Medical Center

location_facility: First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Koranyi National Institute of Pulmonology - Horváth

location_facility: State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department

location_facility: Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie

location_facility: Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1

location_facility: St. Jacob´s Hospital Bardejov - Department of Clinical Oncology

location_facility: First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD

location_facility: The University of New Mexico Comprehensive Cancer Center

location_facility: Semmelweis Egyetem AOK Pulmonologiai Klinika

location_facility: A.O.U. San Luigi Gonzaga, Orbassano (Torino)

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o

location_facility: State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital

location_facility: Seoul National University Boramae Medical Center

location_facility: Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Winship Cancer Institute, Emory University

location_facility: Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca

location_facility: Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Municipal Nonprofit Institution "Odessa Regional Oncology Dispensary" of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department)

title: A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

location_country:
Poland
Australia
Thailand
Canada
France
Lithuania
Slovakia
Hungary
Hong Kong
United States
Ukraine
India
Romania
Malaysia
Philippines
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Bulgaria
Georgia
Russian Federation

ipd_sharing: No


acronym: NATIVE

lead_sponsor: Inventiva Pharma

summary:
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need.

IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic.

The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.

ReferenceCitation: Francque SM, Bedossa P, Ratziu V, Anstee QM, Bugianesi E, Sanyal AJ, Loomba R, Harrison SA, Balabanska R, Mateva L, Lanthier N, Alkhouri N, Moreno C, Schattenberg JM, Stefanova-Petrova D, Vonghia L, Rouzier R, Guillaume M, Hodge A, Romero-Gomez M, Huot-Marchand P, Baudin M, Richard MP, Abitbol JL, Broqua P, Junien JL, Abdelmalek MF; NATIVE Study Group. A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. N Engl J Med. 2021 Oct 21;385(17):1547-1558. doi: 10.1056/NEJMoa2036205.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: Universidad de Sevilla - idUS

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

ReferenceCitation: Sven M F, Pierre B, Manal F A, Quentin M A, Elisabetta B, Vlad R, Philippe HM, Bruno S, Jean-Louis J, Pierre B, Jean-Louis A. A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study. Contemp Clin Trials. 2020 Nov;98:106170. doi: 10.1016/j.cct.2020.106170. Epub 2020 Oct 8.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories: HAL irua

repositories_concat: HAL;irua

repositories_pmh: HAL irua

location_facility: Flinders Medical Centre Department of Hepatology

location_facility: Ospedali Riuniti di Ancona-Università Politecnica delle Marche

location_facility: Institut klinické a experimentální medicíny, IKEM

location_facility: Virgen de la Victoria University Hospital

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin

location_facility: Innere Medizin II - Universitätsklinik Freiburg

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: Lyell McEwin Hospital & The University of Adelaide

location_facility: Florida Digestive Health Specialists, LLP

location_facility: Oddzial Gastroenterologii Hepatologii UCK

location_facility: Granda Ospedale Maggiore Policlinico - Università di Milano

location_facility: Hôpital Purpan - Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: Katedra i Klinika Chorób Zakaźnych i Hepatologii Uniwersytetu Medycznego w Łodzi

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: University of Western Ontario, London Health Sciences Centre

location_facility: Universitätsmedizin Mainz, I. Med. Klinik

location_facility: A.O. Città della Salute e della Scienza di Torino

location_facility: Nottingham University Hospitals NHS Trust

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

location_country:
Germany
Italy
Poland
Slovenia
United Kingdom
Australia
Switzerland
Austria
Belgium
United States
Spain
Mauritius
Czechia
Bulgaria
Canada
France


title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

summary: The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

ReferenceCitation: Coleman M, Belada D, Casasnovas RO, Gressin R, Lee HP, Mehta A, Munoz J, Verhoef G, Corrado C, DeMarini DJ, Zhao W, Li J, Fay K. Phase 2 study of parsaclisib (INCB050465), a highly selective, next-generation PI3Kdelta inhibitor, in relapsed or refractory diffuse large B-cell lymphoma (CITADEL-202). Leuk Lymphoma. 2021 Feb;62(2):368-376. doi: 10.1080/10428194.2020.1832660. Epub 2020 Nov 3.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: Informa

lead_sponsor: Incyte Corporation

location_country:
Italy
Poland
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Chu de Grenoble - Hopital Albert Michallon

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Advocate Medical Group Niles Milwaukee Ave

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza


title: A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to "Standard of Care" Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension

acronym: REGAIN CONTROL

summary:
Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change

Secondary Objectives:

To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change.
To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group).
Change in fasting plasma glucose (FPG).
Change in body weight.
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).
Change in hypoglycemic control subscale (HCS).
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyen-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

lead_sponsor: Sanofi

location_country:
Finland
Ireland
Italy
United Kingdom
Romania
Brazil
Switzerland
Spain
Greece
France

location_facility:
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Investigational Site Number 380020
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Investigational Site Number 380002
Investigational Site Number 826031
Investigational Site Number 076005
Investigational Site Number 724016


summary:
This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.

For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster.

This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

ReferenceCitation: Wang ES, Montesinos P, Minden MD, Lee JH, Heuser M, Naoe T, Chou WC, Laribi K, Esteve J, Altman JK, Havelange V, Watson AM, Gambacorti-Passerini C, Patkowska E, Liu S, Wu R, Philipose N, Hill JE, Gill SC, Rich ES, Tiu RV. Phase 3 trial of gilteritinib plus azacitidine vs azacitidine for newly diagnosed FLT3mut+ AML ineligible for intensive chemotherapy. Blood. 2022 Oct 27;140(17):1845-1857. doi: 10.1182/blood.2021014586.

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repositories_concat: PubMed Central;boa.unimib.it

publisher_dissemination: American Society of Hematology

sponsor_collaborators: Astellas Pharma Global Development, Inc.

location_facility: Robert H. Lurie Comprehensive Cancer Center

location_facility: St. Louis University Cancer Center - Hematology/Oncology

location_facility: University of California, Irvine Medical Center

location_facility: Hematology-Oncology Associates of Northern NJ

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

title: A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

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


acronym: CheckMate 384

intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

summary: The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Southern California Permanente Medical Group

title: A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

location_country:
Germany
Italy
Australia
Austria
United States
Spain
Canada
France


lead_sponsor: Gilead Sciences

summary: The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

ReferenceCitation: Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.

title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

location_country:
Germany
New Zealand
United Kingdom
Australia
United States
Canada
Puerto Rico
France