title: A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

summary:
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.

The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
United States
Ukraine
Belgium
Italy
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Bialostockie Centrum Onkologii ( Site 1412)

location_facility: Policlinico Universitario Gemelli ( Site 1105)

location_facility: Istanbul Acibadem University Atakent Hospital ( Site 1902)

location_facility: Saint Dominic - Jackson Memorial Hospital ( Site 0072)

location_facility: Hillel Yaffe Medical Center ( Site 1011)

location_facility: Saint Vincent Hospital and Health Center ( Site 0012)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)

location_facility: China Medical University Hospital ( Site 2506)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

location_facility: Medipol Universite Hastanesi ( Site 1909)

location_facility: Centro Oncologico Antofagasta ( Site 2804)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)

location_facility: Dartmouth Hitchcock Medical Center ( Site 0024)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2181)

location_facility: A. Tsyb Medical Radiological Research Center ( Site 1513)

location_facility: Hospital General Universitario de Valencia ( Site 1610)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)

location_facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1901)

location_facility: University of Iowa Hospital and Clinics ( Site 0005)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 2909)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1712)

location_facility: Northeast Georgia Medical Center ( Site 0029)

location_facility: Taichung Veterans General Hospital ( Site 2510)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 0400)

location_facility: Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)

location_facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)

location_facility: Presidio Ospedaliero Santa Chiara ( Site 1109)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0312)

location_facility: Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)

location_facility: Seoul National University Hospital ( Site 2403)

location_facility: Central City Clinical Hospital ( Site 2150)

location_facility: Kyiv City Clinical Oncological Center ( Site 2140)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)

location_facility: Miami Valley Hospital [Dayton, OH] ( Site 0073)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)

location_facility: National Taiwan University Hospital ( Site 2502)

location_facility: Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 1605)

location_facility: University of Alabama at Birmingham (UAB) ( Site 0036)

location_facility: Taipei Veterans General Hospital ( Site 2503)

location_facility: Hokkaido University Hospital ( Site 2607)

location_facility: Northwell Health- Monter Cancer Center ( Site 0075)

location_facility: Texas Oncology, P.A. - Bedford ( Site 8005)

location_facility: Dr. Sudarshan K. Sharma, LTD ( Site 0061)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1604)

location_facility: City Clinical Oncology Center ( Site 1505)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)

location_facility: Saitama Medical University International Medical Center ( Site 2604)

location_facility: Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)

location_facility: Sanford Gynecology Oncology ( Site 0004)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)

location_facility: Istituto Europeo di Oncologia ( Site 1100)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)

location_facility: Centre Hospitalier de l'Ardenne ( Site 0303)

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

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)

location_facility: Virginia Cancer Specialists, PC ( Site 8003)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0616)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)

location_facility: Pontificia Universidad Catolica de Chile ( Site 2805)

location_facility: National Cancer Center Hospital ( Site 2605)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)

location_facility: Centro Investigación del Cáncer James Lind ( Site 2810)

location_facility: Staedtisches Krankenhaus Kiel GmbH ( Site 0709)

location_facility: St. Marianna University School of Medicine Hospital ( Site 2613)

location_facility: National Defense Medical College Hospital ( Site 2608)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2910)

location_facility: MD Anderson Cancer Center at Cooper ( Site 0067)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: Hospital Universitario de Donostia ( Site 1602)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2501)

location_facility: Royal Victoria Hospital McGill University Health Centre ( Site 0211)

location_facility: Gunma Prefectural Cancer Center ( Site 2609)

location_facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

location_facility: National Cheng Kung University Hospital ( Site 2508)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1111)

location_facility: FSCC of Special Types of Med. Care and Technologies ( Site 1503)

location_facility: University of Arizona Cancer Center ( Site 0074)

location_facility: Little Company of Mary Hospital ( Site 1700)

location_facility: Osaka International Cancer Institute ( Site 2617)

location_facility: Charite Campus Virchow-Klinikum - CVK ( Site 0700)

location_facility: UT Southwestern Medical Center ( Site 0046)

location_facility: Orszagos Onkologiai Intezet ( Site 0800)

location_facility: Sanford Roger Maris Cancer Center ( Site 0082)

location_facility: Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli

location_facility: Seoul National University Bundang Hospital ( Site 2404)

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)

location_facility: Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 2800)

location_facility: Centre D Oncologie de Gentilly ( Site 0609)

location_facility: Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)

location_facility: Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)

location_facility: Nebraska Methodist Hospital ( Site 0063)

location_facility: ASST Lecco. Ospedale A. Manzoni ( Site 1101)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)

location_facility: Medical Rehabilitation Center ( Site 1502)

location_facility: Hospital Provincial San Pedro de Alcantara ( Site 1607)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0801)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 0306)

location_facility: Memorial Health University Medical Center ( Site 0011)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)

location_facility: Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1508)

location_facility: Washington University - School of Medicine ( Site 0062)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1113)

location_facility: Edith Wolfson Medical Center ( Site 1003)

location_facility: Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)

location_facility: Hospital de Caridade de Ijui ( Site 2712)

location_facility: Hospital Universitario Lucus Augusti ( Site 1609)

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

location_facility: Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)

location_facility: Institut de Cancerologie Lucien Neuwirth ( Site 0613)

location_facility: Niigata Cancer Center Hospital ( Site 2618)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1407)

location_facility: Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)

location_facility: Rush University Medical Center ( Site 0019)

location_facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)

location_facility: Imelda Ziekenhuis Bonheiden ( Site 0301)

location_facility: Princess Margaret Hospital.. ( Site 0202)

location_facility: Instituto Valenciano de Oncologia ( Site 1601)

location_facility: Clinica Universitaria de Navarra ( Site 1600)

location_facility: A.O.U. Federico II di Napoli ( Site 1107)

location_facility: Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)

location_facility: MI Odessa Regional Oncological Centre ( Site 2121)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0057)

location_facility: Changhua Christian Hospital ( Site 2507)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)

location_facility: Cairns and Hinterland Hospital and Health Service ( Site 2201)

location_facility: National Cancer Center Hospital East ( Site 2602)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)

location_facility: Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0704)

location_facility: Instituto do Cancer do Ceara ( Site 2707)

location_facility: Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

location_facility: Shaare Zedek Medical Center ( Site 1005)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)

location_facility: University of the Ryukyus Hospital ( Site 2616)

location_facility: Department of Medical Oncology ( Site 1703)

location_facility: Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 1708)

location_facility: Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)

location_facility: Women and Infants Hospital [Providence, RI] ( Site 0039)

location_facility: Uludag Universitesi Tip Fakultesi ( Site 1904)

location_facility: Disney Family Cancer Center ( Site 0042)

location_facility: Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)

location_facility: RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0035)

location_facility: Iwate Medical University Hospital ( Site 2606)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)

location_facility: A.O. Univ. S. M. della Misericordia ( Site 1114)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1707)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2601)

location_facility: Hospital Nossa Senhora Da Conceicao ( Site 2703)

location_facility: Universitaetsklinikum Muenster ( Site 0720)

location_facility: Kingston Health Sciences Centre ( Site 0207)


title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

summary: This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Alkahest, Inc.

collaborators: Michael J. Fox Foundation for Parkinson's Research

location_country:
United States
Australia
France

location_facility: Rocky Mountain Movement Disorders Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

acronym: CheckMate 9DX

summary: This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
New Zealand
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Colombia
Hong Kong
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Azienda Ospedaliera Specialistica dei Colli Monaldi-Cotugno-CTO

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Sylvester Comprehensive Cancer Center/ UMHC

location_facility: Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore

intervention_type: Other

status_simplified: Ongoing


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation

title: An Open-label, Multi-Center, Phase IIIb Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia Who Are Eligible for "7+3" or "5+2" Chemotherapy

type: EudraCT Number

source: euctr

location_country: Finland Italy Lithuania Slovakia Hungary Norway Romania Sweden Spain Croatia Czechia Bulgaria Estonia Serbia France

ipd_sharing: No


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

ReferenceType: derived

ReferenceCitation: Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Centre of Tuberculosis and Lung Diseases

location_facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

location_facility: Hospital Nuestra Señora de la Misericordia

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carità

location_facility: Communal Institution Central City Hospital

location_facility: Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD

location_facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Clinical Research Centre University of Cape Town

location_facility: University of Texas Southwestern Medical Center

location_facility: Infectious Diseases Center of Vilnius University Hospital Santaros klinikos

location_facility: Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Health Sciences North Horizon Sante-Nord

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: The Third Xiangya Hospital, Central South University

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Rajiv Gandhi Institute of Medical Sciences

location_facility: Bamrasnaradura Infectious Disease Institute

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.

location_facility: Miller Children's at Long Beach Medical Center

location_facility: Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital

location_facility: Fortis Flight Lieutenant Rajan Dhall Hospital

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

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

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD

location_facility: NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska

location_facility: Taipei Medical University-Wan Fang Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Ospedale San Giuseppe - Fatebenefratelli

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

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

location_facility: Suretech Hospital and Research Centre Limited

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Department for Heart Failure and Valvular Disease

location_facility: Hospital de Medicina de São José do Rio Preto

status: Terminated

title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

type: Other Identifier

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Lithuania
Slovakia
Hungary
United States
Latvia
Ukraine
India
Belgium
China
Malaysia
Peru
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

status_simplified: Unknown


title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

acronym: BIO|STREAM HF

summary: The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing_description: No individual participant data in planned to be shared with other researchers

lead_sponsor: Biotronik SE & Co. KG

location_country:
Germany
Poland
Australia
Japan
Czechia
France
Portugal
Slovakia
Hungary
Switzerland
Latvia
Belgium
Italy
United Kingdom
Singapore
Austria
Spain
South Africa
Taiwan
Israel

location_facility: Szpital Kliniczny Przemienienia Pańskiego

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: East-Slovak Cardiology Institute (VUSCH)

location_facility: Maria Heimsuchung - Carita-Klinik Pankow

location_facility: Hospital General Universitario de Valencia

location_facility: Saitama Medical University International Medical Center

location_facility: Schüchtermann Klinik, Herzzentrum Osnabrück-Bad Rothenfelde

location_facility: Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

location_facility: Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH

location_facility: Hospital General Universitario de Alicante

location_facility: Hôpital Privé / Institute Jaques Cartier

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: Le Centre Hospitalier Universitaire de CAEN

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Centre Hospitalier Bretagne Atlantique Prosper Chubert

location_facility: The National Cardiology Institute of Stefan Cardinal Wyszynski - National Research Institute

intervention_type: Device


title: Improvement of Outcome in Elderly Patients or Patients Not Eligible for High-dose Chemotherapy With Aggressive NHL in First Relapse/Progression by Adding Nivolumab to Gemcitabine, Oxaliplatin Plus Rituximab in Case of B-cell Lymphoma

acronym: NIVEAU

summary: This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma

lead_sponsor: Universität des Saarlandes

sponsor_collaborators:
Universität des Saarlandes
Bristol-Myers Squibb
Lymphoma Study Association
University of Leipzig

location_country: Germany France Poland Portugal Netherlands Austria Belgium Israel

location_facility: CHU de Grenoble - Hôpital Albert Michallon - Hématologie Clinique

location_facility: Klinikum Stuttgart, Klinik für Hämatologie

location_facility: UNIVERSITE CATHOLIQUE DE LOUVAIN MONT GODINNE - Hematology

location_facility: Vivantes Klinikum am Urban, Klinik für Innere, Hämatologie und Onkologie

location_facility: Gemeinschaftspraxis Dres. Mohm, Prange-Krex

location_facility: Marie Sklodowska-Curie Institute and Oncology

location_facility: Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere Medizin

location_facility: CHU Côte de Nacre - Service Hématologie Clinique

location_facility: CHU de Nantes - Hôtel Dieu - Hématologie

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Universitätsklinikum Haale (Saale), Klinik für Innere Medizin IV

location_facility: Institut de Cancèrologie Lucien Neuwirth

location_facility: BAG Freiberg-Richter, Jacobasch, Wolf, Illmer

location_facility: Universitätsklinikum Tübingen, Innere Medizin II

location_facility: Universitätsklinik für Innere Medizin I, AKH Wien

location_facility: Kepler Universitätsklinikum GmbH- Med. Campus III

location_facility: St. Antonius-Hospital Eschweiler, Klinik für Hämatologie

location_facility: The Chaim Sheba Medical Center - Division of Hematology and Bone-Marrow Transplantation

location_facility: St. Vincentius Kliniken Karlsruhe, Med. Klinik Abt. 2

location_facility: Ordensklinikum Linz - Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Uniklinikum Ulm, Klinik für Innere Medizin III

location_facility: Charité - Universitätsklinikum Berlin, Med. Klinik m. S. Hämatologie

location_facility: CHU Nancy - Hôpital de Brabois - Service d'Hématologie et Médecine Interne

location_facility: Klinikum Mutterhaus der Borromäerinnen, Med. Abteilung I

location_facility: Klinikum der Universität München, Med. Klinik und Poliklinik III

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr. 1

location_facility: Universitätsmedizin Rostock, Klinik für Hämatologie

location_facility: Westpfalz-Klinikum, Klinik für Innere Medizin I

location_facility: Hôpital Henri Mondor - Unité "Hémopathies Lymphoïdes" - HDJ 11è

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: Universitätsklinikum Regensburg, Klinik für Innere Medizin III

location_facility: CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: CHU Dijon - Hôpital d'Enfants - Hématologie Clinique

location_facility: Instituto Português Oncologia - Hematology

location_facility: Krankenhaus der Barmherzigen Brüder, I. Med. Abteilung

location_facility: CHU de Montpellier - Hématologie Clinique

location_facility: CH Départemental Vendée - Onco-Hématologie

location_facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Hematology

location_facility: Uni Gießen und Marburg, Klinik für Hämatologie

location_facility: UNIVERSITAIR ZIEKENHUIS GENT - Hematology

location_facility: Schwarzwald-Baar Klinikum, Innere Medizin II

location_facility: Universitätsklinikum des Saarlandes, Innere Med. I

location_facility: Universitätsmedizin Göttingen, Klinik für Hämatologie

lead_sponsor_type: academique


title: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib

acronym: INTRIGUE

summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

ReferenceCitation: Bauer S, Jones RL, Blay JY, Gelderblom H, George S, Schoffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Su Y, Meade J, Wang T, Sherman ML, Ruiz-Soto R, Heinrich MC. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Dec 1;40(34):3918-3928. doi: 10.1200/JCO.22.00294. Epub 2022 Aug 10.

oa_host_type: repository

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Nemunaitis J, Bauer S, Blay JY, Choucair K, Gelderblom H, George S, Schoffski P, Mehren MV, Zalcberg J, Achour H, Ruiz-Soto R, Heinrich MC. Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib. Future Oncol. 2020 Jan;16(1):4251-4264. doi: 10.2217/fon-2019-0633. Epub 2019 Nov 22.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Leiden University - Leiden Repository

repositories_concat: LIRIAS (KU Leuven);University of Melbourne - Minerva Access;scholarlypublications.universiteitleiden.nl

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Germany
Poland
Argentina
Australia
Chile
Czechia
Canada
France
Hungary
Switzerland
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Instituto Medicao Especializado Alexander Fleming

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Hospital Universitario Clinico San Carlos

location_facility: University of California San Diego Medical Center

location_facility: UCLA Hematology Oncology Center - Main Site

location_facility: Clinica San Carlos de Apoquindo Red Salud UC Christs

location_facility: Norton Cancer Institute, Audubon Hospital Campus

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: University of Colorado Hospital - Anschutz Cancer Pavillion

location_facility: Universitaetsspital Zuerich, Klinik fuer Onkologie

location_facility: Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi

location_facility: Montefiore Medical Center-Montefiore Medical Park

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Oregon Health & Science University Center for Health and Healing

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Froedtert Hospital-Medical College of Wisconsin

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori


title: A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination With Platinum Doublet Chemotherapy and Radiotherapy for Participants With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)

summary: This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and objective response rate (ORR) by blinded independent central review (BICR).

ReferenceType: result

ReferenceCitation: Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Medical Association

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Poland
New Zealand
United Kingdom
Australia
United States
Korea, Republic of
Spain
Russian Federation
France

location_facility: Chungbuk National University Hospital ( Site 1003)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1422)

location_facility: St Joseph Heritage Healthcare ( Site 1403)

location_facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1209)

location_facility: Hospital Clinic de Barcelona ( Site 1100)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0204)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)

location_facility: Clinica Universitaria de Navarra ( Site 1102)

location_facility: UMass Memorial Medical Center ( Site 1417)

location_facility: Southampton General Hospital ( Site 1204)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)

location_facility: Hospital Universitari Vall d Hebron ( Site 1101)

location_facility: Institut du Cancer de Montpellier ( Site 0300)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302)

location_facility: Royal Free NHS Foundation Trust ( Site 1200)

location_facility: Augusta-Kranken-Anstalt Bochum ( Site 0401)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 0411)

location_facility: Universitatsklinikum Mannheim GmbH ( Site 0413)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0408)

location_facility: Blokhin National Medical Oncology ( Site 0902)

location_facility: Institut de Cancerologie Gustave Roussy ( Site 0305)

location_facility: North Shore University Health System ( Site 1413)

location_facility: Hospital Universitario Virgen Macarena ( Site 1103)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)

location_facility: Bethanien Krankenhaus Moers ( Site 0406)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812)

location_facility: St. Francis Cancer Treatment Center ( Site 1421)

location_facility: MNCCI Port Macquarie Base Hospital ( Site 0200)

location_facility: Southern Medical Day Care Centre ( Site 0201)

location_facility: Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 1434)


title: A Phase I/II Study of Paclitaxel Plus Carboplatin and Durvalumab (MEDI4736) With or Without Oleclumab (MEDI9447) for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

acronym: SYNERGY

summary:
The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach.

CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade.

The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab [anti-PD-L1] +/- MEDI9447 [anti-CD73]) in previously untreated locally recurrent inoperable or metastatic TNBC.

A large translational research program is planned including baseline and dynamic biomarkers

lead_sponsor: Jules Bordet Institute

sponsor_collaborators:
Jules Bordet Institute
AstraZeneca

location_country: Belgium France

location_facility:
Cliniques universitaires Saint Luc
Institut Jules Bordet
Institut Bergonié
Sint-Augustinus, GZA Ziekenhuizen
Institut Paoli-Calmettes
Centre Antoine Lacassagne
Grand Hôpital de Charleroi
Clinique St Pierre
Centre Georges François Leclerc
CHU Besançon
CHU Poitiers
UZ Leuven Gasthuisberg
CHU UCL Namur Sainte-Elisabeth
Hôpitaux Universitaires de Strasbourg
Centre Henri Becquerel
Institut Curie


title: Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial

summary: This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.

ReferenceCitation: Harter P, Pautier P, Van Nieuwenhuysen E, Reuss A, Redondo A, Lindemann K, Kurzeder C, Petru E, Heitz F, Sehouli J, Degregorio N, Wimberger P, Burges A, Cron N, Ledermann J, Lorusso D, Paoletti X, Marme F. Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer - a randomized phase III trial (AGO-OVAR 2.29/ENGOT-ov34). Int J Gynecol Cancer. 2020 Dec;30(12):1997-2001. doi: 10.1136/ijgc-2020-001572. Epub 2020 Jun 30.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories_concat: UCL Discovery

publisher_dissemination: British Medical Journal

lead_sponsor: AGO Research GmbH

sponsor_collaborators:
AGO Research GmbH
Hoffmann-La Roche

location_country: Finland Germany Lithuania Norway Denmark Sweden Switzerland Austria Belgium Spain Estonia France

location_facility: Blois Hospital (Centre Hospitalier de Blois)

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Vilniaus universiteto ligoninė Santaros klinikos

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Praxisgemeinschaft Frauenärzte am Bahnhofsplatz

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: IUCT Oncopole - Institut Claudius Regaud

location_facility: Charité - Universitätsmedizin Berlin (CVK)

location_facility: Institut Català d'Oncologia (ICO) d'Hospitalet

location_facility: Hospital Regional Universitario de Málaga

location_facility: Mammazentrum Hamburg am Krankenhaus Jerusalem

location_facility: SASU Centre d'Oncologie et Radiothérapie 37

location_facility: Institut Català d'Oncologia (ICO) de Girona

location_facility: Vall d'Hebron Instituto de Oncología (VHIO)

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Hospital Clínico Universitario de Valencia


type: Registry Identifier

title: An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

acronym: SEQUOIA

summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.

ReferenceCitation: Mu S, Tang Z, Novotny W, Tawashi M, Li TK, Ou Y, Sahasranaman S. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020 Feb;85(2):391-399. doi: 10.1007/s00280-019-04015-w. Epub 2019 Dec 26.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

ReferenceCitation: Tam CS, Robak T, Ghia P, Kahl BS, Walker P, Janowski W, Simpson D, Shadman M, Ganly PS, Laurenti L, Opat S, Tani M, Ciepluch H, Verner E, Simkovic M, Osterborg A, Trneny M, Tedeschi A, Paik JC, Kuwahara SB, Feng S, Ramakrishnan V, Cohen A, Huang J, Hillmen P, Brown JR. Zanubrutinib monotherapy for patients with treatment naive chronic lymphocytic leukemia and 17p deletion. Haematologica. 2020 Oct 13;106(9):2354-2363. doi: 10.3324/haematol.2020.259432.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, Simkovic M, Shadman M, Osterborg A, Laurenti L, Walker P, Opat S, Chan H, Ciepluch H, Greil R, Tani M, Trneny M, Brander DM, Flinn IW, Grosicki S, Verner E, Tedeschi A, Li J, Tian T, Zhou L, Marimpietri C, Paik JC, Cohen A, Huang J, Robak T, Hillmen P. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1031-1043. doi: 10.1016/S1470-2045(22)00293-5. Epub 2022 Jul 7. Erratum In: Lancet Oncol. 2023 Mar;24(3):e106.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: BeiGene

location_country:
Italy
Poland
New Zealand
United Kingdom
Australia
Sweden
Austria
Belgium
United States
China
Spain
Taiwan
Czechia
Russian Federation
France

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

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Presidio Ospedaliero di Gardone Val Trompia

location_facility: Universitätsklinik für Innere Medizin Salzburg

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

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

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: City Clinical Hospital No. 52 of the Moscow Healthcare Department

location_facility: Institut Català d'Oncologia - L'Hospitalet de Llobregat

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Fujian Medical University Union Hospital

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev

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

location_facility: Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau

location_facility: Institute of Hematology and Hospital of Blood Disease

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Oddział w Gliwicach

location_facility: Municipal Healthcare Institution "Clinical Medical Sanitary Establishment #1"

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich

location_facility: Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Centre Hospitalier Victor Dupouy d'Argenteuil

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Nizhniy Novgorod Regional Clinical Hospital N.A.

location_facility: VA Puget Sound Health Care System, Pathology and Laboratory Medicine Services 113

location_facility: Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością

location_facility: Fakultní Nemocnice Hradec Králové - Ústav Klinické Imunologie a Alergologie

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Limoges CHU de Limoges

location_facility: City Hospitals Sunderland NHS Foundation Trust

location_facility: Cliniques du Sud-Luxembourg Site Clinique Saint-Joseph

location_facility: Universita Degli Studi di Modena-Azienda Ospedaliere Policlinco

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Sahlgrenska Universitetssjukhuset, Östra sjukhuset

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

location_facility: Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Quanzhou First Affiliated Hospital of Fujian Medical University

location_facility: State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region

location_facility: N. N. Blokhin Russian Cancer Research Center

location_facility: The First Affiliated Hospital of Soochow University Branch Shizi

location_facility: Nottingham University Hospitals NHS Trust

location_facility: The First Affiliated Hospital of Nanchang University Branch Donghu


title: PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy

acronym: PONENTE

summary: This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

design_allocation: Non-Randomized

ReferenceCitation: Menzies-Gow A, Gurnell M, Heaney LG, Corren J, Bel EH, Maspero J, Harrison T, Jackson DJ, Price D, Lugogo N, Kreindler J, Burden A, de Giorgio-Miller A, Padilla K, Martin UJ, Garcia Gil E. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022 Jan;10(1):47-58. doi: 10.1016/S2213-2600(21)00352-0. Epub 2021 Oct 4. Erratum In: Lancet Respir Med. 2021 Dec;9(12):e114.

repository_institution: Queen's University Belfast - Research Portal

version: acceptedVersion

ReferenceCitation: Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3):00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: University of Cambridge - Apollo

publisher_dissemination: European Respiratory Society

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:
Germany
Italy
Poland
Colombia
United Kingdom
Argentina
Denmark
Brazil
Sweden
Mexico
Belgium
United States
Spain
Taiwan
Canada
Russian Federation
France

intervention_type: Biological


acronym: Pemetrexed+Platinum Chemotherapy with/ without MK-3475 in TKI-resistant EGFR-mutated Tumors in NSCLC

summary:
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.

Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.

location_facility: Changhua Christian Hospital ( Site 0509)

location_facility: Southwest Hospital, The Third Military Medical University ( Site 0725)

location_facility: Ospedale San Vincenzo di Taormina ( Site 1302)

location_facility: St. Joseph Heritage Healthcare ( Site 0003)

location_facility: Cedars-Sinai Medical Center ( Site 0070)

location_facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1500)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)

location_facility: China Medical University Hospital ( Site 0505)

location_facility: Birmingham Heartlands Hospital ( Site 1002)

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)

location_facility: Taichung Veterans General Hospital ( Site 0504)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0508)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)

location_facility: Universitaetsklinikum Mannheim ( Site 0911)

location_facility: Saint Lukes Hospital of Kansas City ( Site 0060)

location_facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)

location_facility: National Cheng Kung University Hospital ( Site 0506)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1905)

location_facility: Chungbuk National University Hospital ( Site 0404)

location_facility: Istituto Europeo di Oncologia ( Site 1303)

location_facility: Kaiser Permanente Northwest ( Site 0037)

location_facility: Niigata Cancer Center Hospital ( Site 0610)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 0713)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 1102)

location_facility: Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)

location_facility: Kansai Medical University Hospital ( Site 0606)

location_facility: Florence Nightingale Krankenhaus ( Site 0912)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)

location_facility: St James s University Hospital ( Site 1008)

location_facility: Wakayama Medical University Hospital ( Site 0613)

location_facility: Emily Couric Clinical Cancer Center ( Site 0020)

location_facility: Parkland Health & Hospital System ( Site 2102)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0616)

location_facility: Seoul National University Bundang Hospital ( Site 0405)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 0901)

location_facility: Hospital Universitario Virgen Macarena ( Site 1104)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)

location_facility: National Cancer Center Hospital East ( Site 0601)

location_facility: Centre Georges Francois Leclerc ( Site 0809)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)

location_facility: Linkopings Universitetssjukhus ( Site 1504)

location_facility: Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)

location_facility: University of Texas Southwestern Medical Center at Dallas ( Site 0035)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0507)

location_facility: Hong Kong United Oncology Centre ( Site 0306)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: Hospital Universitario 12 de Octubre ( Site 1103)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)

location_facility: Sussex University Hospitals ( Site 1003)

location_facility: Hospital de Caridade de Ijui ( Site 1907)

location_facility: National Cancer Center Hospital ( Site 0603)

location_facility: Fujita Health University Hospital ( Site 0619)

location_facility: Princess Margaret Cancer Centre ( Site 0104)

location_facility: Zhongshan Hospital Fudan University ( Site 0712)

location_facility: Oaxaca Site Management Organization SC ( Site 2001)

location_facility: White Plains Hospital Center for Cancer Care ( Site 0014)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0608)

location_facility: Chelsea & Westminster Hospital ( Site 1001)

location_facility: North Shore University Health System ( Site 0030)

location_facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)

location_facility: Universitaetsklinikum Muenster ( Site 0906)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1909)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0502)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1006)

location_facility: Taipei Veterans General Hospital ( Site 0501)

location_facility: CHU Caen Service de Pneumologie ( Site 0804)

location_facility: Aichi Cancer Center Hospital ( Site 0612)

location_facility: Providence Portland Medical Center ( Site 0097)

location_facility: Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)

location_facility: Skanes Universitetssjukhus Lund ( Site 1503)

location_facility: The First Hospital of Jilin University ( Site 0702)

location_facility: Okayama University Hospital ( Site 0614)

location_facility: Xiangya Hospital of Central South University ( Site 0710)

location_facility: Universita Campus Bio-Medico di Roma ( Site 1304)

location_facility: Centre D Oncologie de Gentilly ( Site 0810)

location_facility: Seoul National University Hospital ( Site 0402)

location_facility: Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)

location_facility: Osaka International Cancer Institute ( Site 0611)

location_facility: Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)

location_facility: Hospitalo Univ. Germans Trias i Pujol ( Site 1100)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)

location_facility: Instituto Jaliscience de Cancerologia ( Site 2000)

location_facility: Peking Union Medical College Hospital ( Site 0703)

location_facility: Instituto Nacional de Cancerologia. ( Site 2007)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0721)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0618)

location_facility: New York Oncology Hematology P.C ( Site 8000)

location_facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 0806)

location_facility: Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)

location_facility: Hong Kong Integrated Oncology Centre ( Site 0304)

location_facility: Hualien Tzu Chi Medical Center-Hospital ( Site 0510)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)

location_facility: Chaim Sheba Medical Center. ( Site 1700)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0621)

location_facility: Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 1502)

location_facility: Hospital Universitari Vall d Hebron ( Site 1106)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 1300)

location_facility: Gachon University Gil Medical Center ( Site 0408)

location_facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)

location_facility: William Osler Health System ( Site 0100)

location_facility: Hopital Jean Minjoz Besancon ( Site 0805)

location_facility: Kanazawa University Hospital ( Site 0617)

title: A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)

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


acronym:
LUCY

 LUCY

summary: This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.

ReferenceCitation: Gelmon KA, Fasching PA, Couch FJ, Balmana J, Delaloge S, Labidi-Galy I, Bennett J, McCutcheon S, Walker G, O'Shaughnessy J; Collaborating Investigators. Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis. Eur J Cancer. 2021 Jul;152:68-77. doi: 10.1016/j.ejca.2021.03.029. Epub 2021 Jun 1.

oa_host_type: publisher

title: A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Japan
United States
Korea, Republic of
Spain
Turkey
Taiwan
Bulgaria
Canada
Russian Federation
France


title: Phase 3 Multicenter Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. Therapy and Control Sub-groups in Older Patients With R/R AML

summary: A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.

lead_sponsor: Cornerstone Pharmaceuticals

location_country:
Germany
Poland
Australia
Austria
Belgium
United States
Korea, Republic of
Spain
France

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

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

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Chao Family Comprehensive Cancer Center (University of California Irvine)

location_facility: University of Texas - Southwestern Medical Center

location_facility: Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

location_facility: University of Iowa-Holden Cancer Care Center


title: A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

acronym: GLOW

summary: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

location_country:
Poland
Israel
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Turkey
Czechia
Canada
Russian Federation
France

location_facility: St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Hopital Haut Leveque Service Maladie Du Sang

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

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

location_facility: Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Hospital Clinico Universitario Salamanca

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni


lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)

location_facility: CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Tianjin Medical University General Hospital

location_facility: FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

location_facility: Division of Hematology and Oncology, Taipei Veterans General Hospital

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: The Oncology Centre; Haematology - Radiation Oncology

location_facility: Taichung Veterans General Hospital; Radiation Oncology

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy

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

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

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

location_facility: Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Winship Cancer Institute of Emory University

location_facility: University of California San Diego Medical Center; Moores Cancer Center

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

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

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

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: Novosibirsk Regional Oncological Dispancer

location_facility: Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological

location_facility: Hopital Timone Adultes; Oncologie Medicale Et Usp

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Cleveland Clinic; Taussig Cancer Institute

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery

location_facility: Seoul National University Bundang Hospital

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: National Taiwan University Hospital; Oncology

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

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

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

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

location_facility: Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

location_facility: Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

location_facility: Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Gustave Roussy Cancer Campus; Radiotherapie

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów G?owy i Szyi

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

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
Hungary
United States
Ukraine
India
Belgium
China
Italy
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


title: Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP)

summary:
The primary objective of the phase Ib of the study is to determine the recommended phase 2 dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.

The primary objective of the phase II is to determine the complete metabolic response (CMR) rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Clinique Universite Catholique de Louvain Saint-Luc


title: Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS): Prospective Observational Cohort of Patients With Moderate-to-severe SLE to Characterize Cross-sectional and Longitudinal Disease Activity, Treatment Patterns and Effectiveness, Outcomes and Comorbidities, Healthcare Resource Utilization, and the Impact of SLE on Quality of Life by Type I Interferon Expression

acronym: SPOCS

summary: SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.

ReferenceCitation: Hammond ER, Tummala R, Berglind A, Syed F, Wang X, Desta B, Nab H. Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature. BMJ Open. 2020 Sep 1;10(9):e036563. doi: 10.1136/bmjopen-2019-036563.

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
Italy
United Kingdom
Australia
United States
Spain
Canada
France


title: A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

summary: This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.

ReferenceCitation: Agarwal N, McGregor B, Maughan BL, Dorff TB, Kelly W, Fang B, McKay RR, Singh P, Pagliaro L, Dreicer R, Srinivas S, Loriot Y, Vaishampayan U, Goel S, Curran D, Panneerselvam A, Schwickart M, Choueiri TK, Pal S. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). Lancet Oncol. 2022 Jul;23(7):899-909. doi: 10.1016/S1470-2045(22)00278-9. Epub 2022 Jun 9.

ReferenceCitation: Pal SK, McGregor B, Suarez C, Tsao CK, Kelly W, Vaishampayan U, Pagliaro L, Maughan BL, Loriot Y, Castellano D, Srinivas S, McKay RR, Dreicer R, Hutson T, Dubey S, Werneke S, Panneerselvam A, Curran D, Scheffold C, Choueiri TK, Agarwal N. Cabozantinib in Combination With Atezolizumab for Advanced Renal Cell Carcinoma: Results From the COSMIC-021 Study. J Clin Oncol. 2021 Nov 20;39(33):3725-3736. doi: 10.1200/JCO.21.00939. Epub 2021 Sep 7.

ipd_sharing: Undecided

lead_sponsor: Exelixis

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
France

location_facility:
Exelixis Clinical Site #96
Exelixis Clinical Site #113
Exelixis Clinical Site #29
Exelixis Clinical Site #21
Exelixis Clinical Site #101
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Exelixis Clinical Site #1
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Exelixis Clinical Site #115
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Exelixis Clinical Site #89
Exelixis Clinical Site #30
Exelixis Clinical Site #27
Exelixis Clinical Site #86
Exelixis Clinical Site #50
Exelixis Clinical Site #2
Exelixis Clinical Site #84
Exelixis Clinical Site #123
Exelixis Clinical Site #116
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Exelixis Clinical Site #38
Exelixis Clinical Site #124
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Exelixis Clinical Site #24
Exelixis Clinical Site #65
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Exelixis Clinical Site #7
Exelixis Clinical Site #110
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Exelixis Clinical Site #114
Exelixis Clinical Site #104
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Exelixis Clinical Site #112
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title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

summary: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

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 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:
Germany
Italy
Lithuania
Hungary
Australia
Brazil
Japan
United States
China
Spain
Taiwan
Peru
Canada
Russian Federation
France

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Tokyo Medical and Dental University Hospital

location_facility: National Clinical Research Inc.-Richmond

location_facility: Tianjin Medical University General Hospital

location_facility: The Second Affiliated Hospital, Zhejiang University

location_facility: California Neuroscience Research Medical Group, Inc

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

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Australian Alzheimer's Research Foundation

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: National Taiwan University Hospital; Neurology

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Beijing Tian Tan Hospital,Capital Medical University

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

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Semmelweis University; Department of Neurology

location_facility: Ohio State University; College of Medicine

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

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Kaohsiung Medical University Hospital; Neurology

location_facility: Hospital Nacional Cayetano Heredia; Servicio de Neurologia

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

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

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

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

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Fujian Medical University Union Hospital

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Hospital Ruber Internacional; Servicio de Neurología

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

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

location_facility: Center for Advanced Research & Education

location_facility: Neurological Associates of Long Island, PC

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

location_facility: Beijing Anding Hospital, Capital Medical University

location_facility: Research Center for Clinical Studies, Inc.

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

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

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Clinica Internacional; Unidad De Investigacion

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

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

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

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

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: The Medical Arts Health Research Group - West Vancouver

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

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

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

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: The University of Hong Kong-Shenzhen Hospital

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

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Southern Illinois University, School of Medicine

location_facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Alzheimer?s Research and Treatment Center

location_facility: Vilnius University Hospital Santariskiu Clinics; Neurology

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

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

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

location_facility: China Medical University Hospital; Neurology

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

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

location_facility: Sun Yat-sen Memorial Hospital; Neurology

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

location_facility: Guangzhou First Municipal People's Hospital

location_facility: National Center of Neurology and Psychiatry

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hôpital Avicenne; Centre de Recherche Clinique

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: Neurology Consultants of Dallas; Research Department

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

location_facility: Advanced Memory Research Institute of NJ

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: University of Mississippi Medical Center

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Guangdong Provincial People's Hospital; Breast

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology

location_facility: The First Affiliated Hospital of Wenzhou Medical College


title: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma

summary: This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.

ReferenceType: background

ReferenceCitation: Ren Z, Ducreux M, Abou-Alfa GK, Merle P, Fang W, Edeline J, Li Z, Wu L, Assenat E, Hu S, Rimassa L, Zhang T, Blanc JF, Pan H, Ross P, Yen CJ, Tran A, Shao G, Bouattour M, Chen Y, Meyer T, Hou J, Tougeron D, Bai Y, Hou MM, Meng Z, Wu J, Li V, Chica-Duque S, Cheng AL. Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Liver Cancer. 2022 Oct 4;12(1):72-84. doi: 10.1159/000527175. eCollection 2023 Feb.

ReferenceCitation: Serrano D, Podger L, Barnes G, Song J, Tang B. Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma. Qual Life Res. 2022 Mar;31(3):937-950. doi: 10.1007/s11136-021-02992-1. Epub 2021 Sep 13.

location_country:
Germany
Italy
Poland
United Kingdom
China
Spain
Taiwan
France

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Fujian Medical University Union Hospital

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Nanfang Hospital of Southern Medical University

location_facility: The Second Hospital of Anhui Medical Hospital

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Chiayi Chang Gung Memorial Hospital of the Chang Gung Medical Foundation

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Chinese PLA General Hospital Medical School of Chinese PLA

location_facility: The First affiliated hospital of Nanchang University

location_facility: Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Harbin Medical University Cancer Hospital

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

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary:
The primary objectives of this study are:

Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.

Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

The key secondary objectives are:

Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells.

Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

lead_sponsor: Regeneron Pharmaceuticals

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_country:
Ireland
Italy
Lithuania
Poland
Slovakia
Romania
Austria
United States
China
Korea, Republic of
Thailand
Greece
Malaysia
Turkey
Ukraine
Georgia
Russian Federation
France

location_facility:
Regeneron Research Site
Regeneron research Site
Regeneron Research Site #1
Regeneron Research Site #2