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

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

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

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

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

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0618)

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

location_facility: Osaka International Cancer Institute ( Site 0611)

location_facility: William Osler Health System ( Site 0100)

location_facility: St. Joseph Heritage Healthcare ( Site 0003)

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

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

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

location_facility: National Cancer Center Hospital ( Site 0603)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 1502)

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

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

location_facility: Chaim Sheba Medical Center. ( Site 1700)

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

location_facility: Niigata Cancer Center Hospital ( Site 0610)

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

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

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

location_facility: Taipei Veterans General Hospital ( Site 0501)

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

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

location_facility: Changhua Christian Hospital ( Site 0509)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1500)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0507)

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

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

location_facility: Chelsea & Westminster Hospital ( Site 1001)

location_facility: Skanes Universitetssjukhus Lund ( Site 1503)

location_facility: Seoul National University Hospital ( Site 0402)

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

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

location_facility: Sussex University Hospitals ( Site 1003)

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

location_facility: Hospital Universitari Vall d Hebron ( Site 1106)

location_facility: Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)

location_facility: Hong Kong Integrated Oncology Centre ( Site 0304)

location_facility: Kaiser Permanente Northwest ( Site 0037)

location_facility: Hong Kong United Oncology Centre ( Site 0306)

location_facility: Taichung Veterans General Hospital ( Site 0504)

location_facility: Wakayama Medical University Hospital ( Site 0613)

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

location_facility: Fujita Health University Hospital ( Site 0619)

location_facility: North Shore University Health System ( Site 0030)

location_facility: Hospital de Caridade de Ijui ( Site 1907)

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

location_facility: Universitaetsklinikum Muenster ( Site 0906)

location_facility: Aichi Cancer Center Hospital ( Site 0612)

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

location_facility: National Cheng Kung University Hospital ( Site 0506)

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

location_facility: CHU Caen Service de Pneumologie ( Site 0804)

location_facility: Kanazawa University Hospital ( Site 0617)

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

location_facility: Zhongshan Hospital Fudan University ( Site 0712)

location_facility: Hospital Universitario Virgen Macarena ( Site 1104)

location_facility: Istituto Europeo di Oncologia ( Site 1303)

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

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

location_facility: National Taiwan University Hospital ( Site 0500)

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

location_facility: Okayama University Hospital ( Site 0614)

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

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

location_facility: Parkland Health & Hospital System ( Site 2102)

location_facility: Cedars-Sinai Medical Center ( Site 0070)

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

location_facility: Princess Margaret Cancer Centre ( Site 0104)

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

location_facility: Instituto Jaliscience de Cancerologia ( Site 2000)

location_facility: Hopital Jean Minjoz Besancon ( Site 0805)

location_facility: Providence Portland Medical Center ( Site 0097)

location_facility: Birmingham Heartlands Hospital ( Site 1002)

location_facility: Centre Georges Francois Leclerc ( Site 0809)

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

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

location_facility: National Cancer Center Hospital East ( Site 0601)

location_facility: Instituto Nacional de Cancerologia. ( Site 2007)

location_facility: Hospital Universitario 12 de Octubre ( Site 1103)

location_facility: Universitaetsklinikum Mannheim ( Site 0911)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 0901)

location_facility: Kansai Medical University Hospital ( Site 0606)

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

location_facility: Emily Couric Clinical Cancer Center ( Site 0020)

location_facility: Chungbuk National University Hospital ( Site 0404)

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

location_facility: Ospedale San Vincenzo di Taormina ( Site 1302)

location_facility: St James s University Hospital ( Site 1008)

location_facility: Seoul National University Bundang Hospital ( Site 0405)

location_facility: Florence Nightingale Krankenhaus ( Site 0912)

location_facility: Linkopings Universitetssjukhus ( Site 1504)

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

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

location_facility: Gachon University Gil Medical Center ( Site 0408)

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

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

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

location_facility: China Medical University Hospital ( Site 0505)

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

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

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

location_facility: Oaxaca Site Management Organization SC ( Site 2001)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)

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

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

location_facility: Centre D Oncologie de Gentilly ( Site 0810)

location_facility: Peking Union Medical College Hospital ( Site 0703)

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.


ipd_sharing: Yes

status: Terminated

primary_purpose: Treatment

intervention_type: Drug

title: A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

enrollment_type: Actual

location_country:
Poland
Taiwan
Brazil
Portugal
Spain
Italy
Austria
Australia
Argentina
Switzerland
United States
France
Israel
Norway
Belgium
Japan
Germany
Turkey
Bulgaria
Czechia

location_facility:
Dana Farber Cancer Institute
Novartis Investigative Site
University of Chicago Medical Center
Oregon Health and Science University

summary:
The purpose of this study is to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off).

This study will evaluate the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR<0.05) AML.

lead_sponsor_type: industriel

status_simplified: Unknown


title: Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (Devimistat) in Combination With High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) Therapy and Control Sub-groups: Combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and Combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (≥ 50 Years) With Relapsed/Refractory Acute Myeloid Leukemia (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.

ipd_sharing: Undecided

lead_sponsor: Cornerstone Pharmaceuticals

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

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: University of Iowa-Holden Cancer Care Center

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

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

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

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon


type: Other Identifier

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).

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

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

location_facility: Hopital Haut Leveque Service Maladie Du Sang

location_facility: Hospital Clinico Universitario Salamanca

location_facility: S.P. Botkin Moscow City Clinical Hospital

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

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

location_facility: Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi

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

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Nizhniy Novgorod Region Clinical Hospital

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

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

location_facility: Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

location_facility: Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

status_simplified: Ongoing


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

lead_sponsor: Hoffmann-La Roche

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

location_facility: IPO do Porto; Servico de Oncologia Medica

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

location_facility: Songklanagarind Hospital; Department of Oncology

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

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

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

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

location_facility: Hopital Timone Adultes; Oncologie Medicale Et Usp

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

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

location_facility: Tianjin Medical University General Hospital

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Miami Cancer Institute of Baptist Health, Inc.

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

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

location_facility: Ivano-Frankivsk Regional Oncology Center

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

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

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

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

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

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

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy

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

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: The Oncology Centre; Haematology - Radiation Oncology

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

location_facility: BHI of Omsk region Clinical Oncology Dispensary

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

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

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

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

location_facility: National Taiwan University Hospital; Oncology

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Winship Cancer Institute of Emory University

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

location_facility: Taichung Veterans General Hospital; Radiation Oncology

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

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

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

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

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

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

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

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

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

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

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Gustave Roussy Cancer Campus; Radiotherapie

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Seoul National University Bundang Hospital

location_facility: GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

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

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

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

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

location_facility: Novosibirsk Regional Oncological Dispancer

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

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

location_facility: Cleveland Clinic; Taussig Cancer Institute

location_facility: Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

location_facility: IPO de Coimbra; Servico de Oncologia Medica

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

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

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)


title: Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment

summary: The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.

lead_sponsor: TauRx Therapeutics Ltd

location_country:
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Belgium

location_facility: Clinica Neurologica Santa Maria della Misericordia

location_facility: Georgia Neurology and Sleep Medicine Associates

location_facility: Neuro-Behavioral Clinical Research, Inc.

location_facility: Alzheimer's Research and Treatment Center

location_facility: Azienda Ospedaliera San Gerardo - Clinica Neurologica

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Istituto Neurologico Casimiro Mondino, IRCCS

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: University of Perugia, Ospedale S.M. della Misericordia

location_facility: L&C Professional Medical Research Institute

location_facility: Hospital Universitario QuironSalud Madrid

location_facility: Miami Dade Medical Research Institute, LLC

location_facility: Centro de salud de San Juan, Unidad de Investigación Neurociencias

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: IRCCS Centro S. Giovanni di Dio Fatebenefratelli

location_facility: CRC Gerontopole Cite de la Sante, Hôpital La Grave


type: Registry Identifier

title: RATIONALE-208: 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 is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Participants with Previously Treated Hepatocellular Unresectable Carcinoma.

status: Completed

lead_sponsor: BeiGene

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
France
China
Germany

location_facility: The Second Affiliated Hospital of Nanchang University

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

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Chinese PLA General Hospital Medical School of Chinese PLA

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

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

location_facility: Shanghai Cancer Hospital, Fudan University

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

location_facility: Nanfang Hospital of Southern Medical University

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: The Second Hospital of Anhui Medical Hospital

location_facility: The First affiliated hospital of Nanchang University

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Fujian Medical University Union Hospital

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

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

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

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

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Harbin Medical University Cancer Hospital

status_simplified: Completed


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

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

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

intervention_type: Other


acronym: TANGO

title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

lead_sponsor: Biogen

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Poland
Spain
Italy
Australia
Sweden
United States
France
Japan
Germany

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Synexus Clinical Research US, Inc. - Orlando

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Mary S. Easton Center for Alzheimer's Disease Research, UCLA

location_facility: Institut fuer Schlaganfall- und Demenzforschung (ISD)

location_facility: Research Center for Clinical Studies West

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Irvine Center for Clinical Research, Inc.

location_facility: Advanced Memory Enhancement Center of NJ

location_facility: Mazowiecki Szpital Wojewódzki w Warszawie Sp z oo

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: The Research Center of Southern California

location_facility: Studienzentrum fur Neurologie und Psychiatrie

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: The Cognitive Research Center of New Jersey

location_facility: Brigham and Women's Hospital Department of Neurology

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Charite - Campus Berlin Buch, Experimental and Clinical Research Center (ECRC)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Synexus Clinical Research US, Inc. - The Villages

location_facility: New York University Medical Center PRIME

summary:
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.

The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.


title: Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC

summary:
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.

MCLA-128 is given in combinations in two metastatic breast cancer (MBC) populations, HER2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2).

Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially MCLA-128 is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet.

The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet.

In Cohort 2 MCLA-128 is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Merus N.V.

location_country:
Portugal
Spain
United Kingdom
United States
France
Belgium
Netherlands

location_facility: Vall D'Hebron Institute of Oncology (VHIO)


title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)

summary:
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.

ReferenceType: derived

ReferenceCitation: Boyer M, Şendur MAN, Rodríguez-Abreu D, Park K, Lee DH, Çiçin I, Yumuk PF, Orlandi FJ, Leal TA, Molinier O, Soparattanapaisarn N, Langleben A, Califano R, Medgyasszay B, Hsia TC, Otterson GA, Xu L, Piperdi B, Samkari A, Reck M; KEYNOTE-598 Investigators. Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study. J Clin Oncol. 2021 Jul 20;39(21):2327-2338. doi: 10.1200/JCO.20.03579. Epub 2021 Jan 29.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
South Africa
Poland
Australia
Argentina
Turkey
Mexico
Brazil
Canada
Hungary
Germany
Taiwan
Ireland
Latvia
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 1326)

location_facility: Seoul National University Hospital ( Site 2303)

location_facility: Ospedale San Gerardo ASST Monza ( Site 1002)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)

location_facility: Texas Oncology-Longview Cancer Center ( Site 8009)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)

location_facility: Universitaetsklinikum Schleswig Holstein. ( Site 0918)

location_facility: Hospital Germans Trias i Pujol ( Site 1207)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)

location_facility: Evangelische Lungenklinik Berlin ( Site 0903)

location_facility: Royal Wolverhampton Hospitals NHS Trust ( Site 1323)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0706)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0034)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)

location_facility: C.H.R.U de Lille - Hopital Calmette ( Site 0805)

location_facility: Mid Ohio Oncology/Hematology Inc. ( Site 0003)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)

location_facility: Hospital Privado Centro Medico Cordoba ( Site 0206)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0801)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)

location_facility: Pauls Stradins Clinical University Hospital ( Site 1100)

location_facility: Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)

location_facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)

location_facility: Dr G.A. Landers Specialist Oncologist ( Site 1803)

location_facility: Karadeniz Teknik Universitesi ( Site 1910)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1807)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1321)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 0504)

location_facility: Kyiv City Clinical Oncological Center ( Site 2014)

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)

location_facility: University of Stellenbosch and Tygerberg Hospital ( Site 1810)

location_facility: University Hospital Limerick ( Site 1403)

location_facility: Clinica Universidad Catolica del Maule ( Site 0413)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)

location_facility: Ospedale Santa Maria della Misericordia ( Site 1008)

location_facility: Tennessee Cancer Specialists ( Site 0017)

location_facility: Royal Free NHS Foundation Trust ( Site 1324)

location_facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)

location_facility: University of Tennessee Erlanger Oncology & Hematology ( Site 0026)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)

location_facility: Clinica Peruano Americana S.A. ( Site 0703)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)

location_facility: Centre Hopitalier Intercommunal Creteil ( Site 0802)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1907)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1616)

location_facility: AORN dei Colli Plesso Monaldi ( Site 1003)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)

location_facility: MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1200)

location_facility: The Ohio State University Wexner Medical Center ( Site 0016)

location_facility: CISSS-CA Hotel-Dieu de Levis ( Site 0108)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)

location_facility: Riga East Clinical University Hospital ( Site 1111)

location_facility: CEPON Centro de Pesquisa Oncológicas ( Site 0307)

location_facility: Orszagos Onkologiai Intezet ( Site 1509)

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)

location_facility: Universitaetsklinikum Heidelberg ( Site 0900)

location_facility: Centro Oncologico Riojano Integral ( Site 0203)

location_facility: Universitaetsklinikum Leipzig ( Site 0919)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0311)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 1203)

location_facility: The Christie NHS Foundation Trust ( Site 1301)

location_facility: CHU de Brest. Hopital Morvan ( Site 0800)

location_facility: Texas Oncology-Arlington South ( Site 8006)

location_facility: National Taiwan University Hospital ( Site 2400)

location_facility: Hospital Clinico Vina del Mar ( Site 0400)

location_facility: Hospital Universitari Vall d Hebron ( Site 1211)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)

location_facility: Hospital San Pedro de Alcantara ( Site 1208)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1511)

location_facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)

location_facility: Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)

location_facility: CISSS de la Monteregie-Centre ( Site 0100)

location_facility: New England Cancer Specialists ( Site 0019)

location_facility: Avix Investigacion Clinica S.C. ( Site 0600)

location_facility: Escola Paulista de Medicina - UNIFESP ( Site 0304)

location_facility: Universitas Annex National Hospital ( Site 1800)

location_facility: Centro de Investigacion Clinica del Country ( Site 0500)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)

location_facility: Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)

location_facility: Humanitas Research Hospital ( Site 1004)

location_facility: Instituto de Oncologia de Rosario ( Site 0200)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0004)

location_facility: Oncologica de Puebla SA de CV ( Site 0606)

location_facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)

location_facility: Hospital do Servidor Publico do Estado ( Site 0308)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0908)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)

location_facility: Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)

location_facility: Disney Family Cancer Center ( Site 0035)

location_facility: Lahey Hospital & Medical Center ( Site 0020)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)

location_facility: MI Odessa Regional Oncological Centre ( Site 2004)

location_facility: The Royal Marsden NHS Foundation Trust.. ( Site 1327)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1909)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2015)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1505)

location_facility: Florida Hospital Cancer Institute ( Site 0009)

location_facility: Severance Hospital Yonsei University Health System ( Site 2300)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 2404)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8001)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)

location_facility: IRCCS Casa Sollievo della Sofferenza ( Site 1009)

location_facility: Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0306)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 1503)

location_facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0404)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)

location_facility: Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)

location_facility: Istituto Europeo di Oncologia ( Site 1007)

location_facility: Clinica Internacional Sede San Borja ( Site 0701)

location_facility: HELIOS Klinikum Emil von Behring ( Site 0905)

location_facility: St-Jerome Medical Research Inc ( Site 0113)

location_facility: National Cheng Kung University Hospital ( Site 2401)

location_facility: Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)

location_facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)

location_facility: Instituto Nacional del Cancer ( Site 0406)

location_facility: GVI Oncology Clinical Research Centre ( Site 1802)

location_facility: Changhua Christian Hospital ( Site 2406)

location_facility: Medical Park Izmir Hospital ( Site 1900)

location_facility: Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)

location_facility: Medical College of Wisconsin Clinical Cancer Center ( Site 0027)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0602)

location_facility: St Vincents Hospital Melbourne ( Site 2101)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)

location_facility: China Medical University Hospital ( Site 2403)

location_facility: Uludag Universitesi Tip Fakultesi ( Site 1914)

location_facility: Texas Oncology-Flower Mound ( Site 8007)

location_facility: John Wayne Cancer Institute ( Site 0021)

intervention_type: Biological


status: Recruiting

title: An Open-label, First-in-human, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose and / or Recommended Phase II Dose of the ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas

lead_sponsor: Bayer

ReferenceCitation: Lücking U, Wortmann L, Wengner AM, Lefranc J, Lienau P, Briem H, Siemeister G, Bömer U, Denner K, Schäfer M, Koppitz M, Eis K, Bartels F, Bader B, Bone W, Moosmayer D, Holton SJ, Eberspächer U, Grudzinska-Goebel J, Schatz C, Deeg G, Mumberg D, von Nussbaum F. Damage Incorporated: Discovery of the Potent, Highly Selective, Orally Available ATR Inhibitor BAY 1895344 with Favorable Pharmacokinetic Properties and Promising Efficacy in Monotherapy and in Combination Treatments in Preclinical Tumor Models. J Med Chem. 2020 Jul 9;63(13):7293-7325. doi: 10.1021/acs.jmedchem.0c00369. Epub 2020 Jun 28.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

enrollment_type: Anticipated

location_country:
United Kingdom
Canada
Switzerland
United States
France
China
Singapore
Japan
Germany

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Oncology Institute of Southern Switzerland

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: University Hospitals Cleveland Medical Center

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Hôpital Cantonal Universitaire de Genève

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Fairfax-Northern Virginia Hematology/Oncology, PC

location_facility: Integrated Cancer Center of the CHU de Québec

location_facility: Klinikum der Universität München Grosshadern

summary: The ATR (ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumors and lymphomas. The purpose of the proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further, the response of the cancer to the treatment will be determined.


title: A Pilot Study of Personalized Biomarker-based Treatment Strategy or Immunotherapy in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

acronym: UPSTREAM

summary: This is a biomarker-driven trial that will enroll patients with recurrent or metastatic squamous cell carcinoma of the head and neck progressing after first-line platinum-based chemotherapy. Based on potential biomarkers and molecular alterations identified in the biopsy from the central platform, patients will be allocated in different cohorts. There will be biomarker-positive patient cohorts and immunotherapy cohorts.

ReferenceCitation: Galot R, Le Tourneau C, Guigay J, Licitra L, Tinhofer I, Kong A, Caballero C, Fortpied C, Bogaerts J, Govaerts AS, Staelens D, Raveloarivahy T, Rodegher L, Laes JF, Saada-Bouzid E, Machiels JP. Personalized biomarker-based treatment strategy for patients with squamous cell carcinoma of the head and neck: EORTC position and approach. Ann Oncol. 2018 Dec 1;29(12):2313-2327. doi: 10.1093/annonc/mdy452. Review.

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

location_country:
France
Italy
United Kingdom
Belgium

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

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

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

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

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre


title: A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen

ReferenceCitation: Powles T, Yuen KC, Gillessen S, Kadel EE 3rd, Rathkopf D, Matsubara N, Drake CG, Fizazi K, Piulats JM, Wysocki PJ, Buchschacher GL Jr, Alekseev B, Mellado B, Karaszewska B, Doss JF, Rasuo G, Datye A, Mariathasan S, Williams P, Sweeney CJ. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Nat Med. 2022 Jan;28(1):144-153. doi: 10.1038/s41591-021-01600-6. Epub 2022 Jan 10.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: University of Colorado; Division of Medical Oncology

location_facility: James Cancer Hospital;Solove Research Institute

location_facility: Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Ospedale Area Aretina Nord; U.O.C. Oncologia

location_facility: Medizinische Universität Wien; Universitätsklinik für Urologie

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Kaiser Permanente San Diego - Los Angeles

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Medical University of Bialystok; Oncology clinic

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: University of Pittsburgh Cancer Institute; Division of Medical Oncology

location_facility: Urology Cancer Center & GU Research Network

location_facility: Chang Gung Memorial Hospital-LinKou; Urology

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: IRCCS AOU San Martino - IST; Oncologia Medica 1

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

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

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Niigata University Medical & Dental Hospital

location_facility: Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: University Hospital of Patras Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Royal Marsden Hospital; Institute of Cancer Research

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

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: CHU de Québec - Université Laval - Hôtel-Dieu de Québec

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

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

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Athens Medical Center; Dept. of Oncology

location_facility: Woj. Wielospec. Centrum Onkologii i Traumatologii

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

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

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Concord Repatriation General Hospital; Concord Cancer Centre

location_facility: Nebraska Cancer Specialists; Oncology Hematology West, PC

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Friendship Hospital, Capital Medical University

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: Virginia Cancer Specialists - Alexandria

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

summary: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.


title: TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

ReferenceCitation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17. Review.

ipd_sharing_description:
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Denmark
Spain
Ireland
Italy
Australia
United Kingdom
Canada
United States
France
Israel
Belgium
Germany

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: Presidio Ospedaliero Santa Chiara di Trento

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Walter Reed National Military Medical Center

location_facility: Adelaide & Meath Hospital, Incorporating the National Children's Hospital

location_facility: Marques de Valdecilla University Hospital (HUMV)

location_facility: Alegent Health Bergan Mercy Hospital , GU Research Network

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Premier MEdical Group of the Hudson Valley PC

location_facility: Barwon Health, University Hospital Geelong

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Oxford Cancer Centre, Medical Oncology Unit

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Rambam Health Care Campus (RHCC), Rambam Medical Center

location_facility: Centre Hospitalier Universitaire Dr-Georges-L.-Dumont

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: Apotheke des Städtischen Klinikums Braunschweig

location_facility: Lakeridge Health Medical Specialty Medical Oncology

location_facility: Hospital General Universitario de Guadalajara

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: University of Florida Health Cancer Center

location_facility: Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

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

location_facility: Medical Oncology Hematology Consultants - USOR

location_facility: University of Washington Fred Hutchinson Cancer Research Center

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Hospital Universitario Central de Asturias

location_facility: Northwest Cancer Specialist DBA Compass Oncology


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

summary: This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

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.

lead_sponsor: Acerta Pharma BV

location_country:
Spain
Italy
Ukraine
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Mexico
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
New Zealand
Vietnam
Korea, Republic of
France


title: Risk-based, Response-adapted, Phase II Open-label Trial of Nivolumab + Brentuximab Vedotin (N + Bv) for Children, Adolescents, and Young Adults With Relapsed/Refractory (R/R) CD30 + Classic Hodgkin Lymphoma (cHL) After Failure of First-line Therapy, Followed by Brentuximab + Bendamustine (Bv + B) for Participants With a Suboptimal Response (CheckMate 744: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation)

acronym: CheckMate 744

summary: The purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with Hodgkin's lymphoma (cHL). Eligible patients are children, adolescents, and young adults relapsed or refractory to first line.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
United States
France
Germany
Czechia

location_facility: Childrens Hospital Of Pittsburgh Of Upmc

location_facility: The Montreal Children's Hospital of the MUHC

location_facility: Cincinnati Children'S Hospital Medical Center

location_facility: Nemours / A. I. duPont Hospital for Children

location_facility: Washington University School Of Medicine

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Smilow Cancer Hospital At Yale New Haven Hospital

location_facility: Children'S Hospital & Research Center At Oakland

location_facility: Dell Children'S Medical Center Of Central Texas

location_facility: Lucile Packard Children'S Research Hospital/Stanford Univ

location_facility: University Of Mississippi Medical Center


title: A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome (Cohort 2)

summary: The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet syndrome.

ReferenceType: result

ReferenceCitation: Nabbout R, Mistry A, Zuberi S, Villeneuve N, Gil-Nagel A, Sanchez-Carpintero R, Stephani U, Laux L, Wirrell E, Knupp K, Chiron C, Farfel G, Galer BS, Morrison G, Lock M, Agarwal A, Auvin S; FAiRE, DS Study Group. Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens: A Randomized Clinical Trial. JAMA Neurol. 2020 Mar 1;77(3):300-308. doi: 10.1001/jamaneurol.2019.4113.

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.

ReferenceCitation: Sullivan J, Perry MS, Wheless JW, Galer B, Gammaitoni A. Fenfluramine responder analyses and numbers needed to treat: Translating epilepsy trial data into clinical practice. Eur J Paediatr Neurol. 2021 Mar;31:10-14. doi: 10.1016/j.ejpn.2021.01.005. Epub 2021 Jan 22.

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

location_country:
Spain
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: HÔPITAL FEMME-MÈRE-ENFANT Hôpital Service de Neurologie Pédiatrique

location_facility: Kleinwachau Sächsisches Epilepsiezentrum Radeberg

location_facility: Bc Children'S Hospital Division of Neurology

location_facility: Cliníca Universidad de Navarra Nidad de Neuropediatría

location_facility: Great Ormond Street Hospital For Children Nhs Foundation Trust

location_facility: Hospital Ruber Internacional-Servicio de Neurología

location_facility: Ann & Robert H. Lurie Children'S Hospital of Chicago

location_facility: Chu Sainte-Justine Hospital Neurology Clinic

location_facility: Universitätsklinikum Schleswig-Holstein, Klinik Für Neuropädiatrie

location_facility: Krankenhaus Mara, Epilepsie-Zentrum Bethel

location_facility: Hôpital de La Timone, Service de Neuro-Métabolisme Pédiatrique

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Evelina London Children'S Hospital, Paediatric Neurosciences

location_facility: Alder Hey Children'S Nhs Foundation Trust, Littlewood'S Neurosciences Unit

location_facility: Chu Amiens Picardie Service de Neurologie Pédiatrique

location_facility: Royal Hospital For Children, Queen Elizabeth University, Institute of Neurosciences Hospital


title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Canada
Ukraine
Sweden
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: The University of Chicago Medical Center

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Kobe City Medical Center General Hospital

location_facility: University of New Mexico School of Medicine

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

location_facility: Hospital of the University of Pennsylvania

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Heart of England NHS Foundation Trust - Heartlands Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

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

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: West Virginia University Hospitals, Inc.

location_facility: A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

location_facility: East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hospital Universitario Central de Asturias

summary:
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone:

High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide, and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor [G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).
Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).
BSC.


acronym: Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis (ASCEND-D)

title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

ReferenceCitation: Singh AK, Carroll K, Perkovic V, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Więcek A, Blackorby A, Cizman B, Cobitz AR, Davies R, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2325-2335. doi: 10.1056/NEJMoa2113379. Epub 2021 Nov 5.

ReferenceCitation: Singh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
New Zealand
Korea, Republic of
France
Netherlands

summary: The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.


title: Randomized Efficacy and Safety Trial With Oral S 44819 After Recent Ischemic Cerebral Event. International, Multi-centre, Randomized, Doubleblind Placebo-controlled Phase II Study. (RESTORE BRAIN Study)

summary: The purpose of this study is to assess the efficacy and safety of S 44819 in enhancing functional recovery after an ischemic stroke.

ReferenceType: background

ReferenceCitation: Chabriat H, Bassetti CL, Marx U, Picarel-Blanchot F, Sors A, Gruget C, Saba B, Wattez M, Audoli ML, Hermann DM. Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study. Trials. 2020 Feb 3;21(1):136. doi: 10.1186/s13063-020-4072-2.

ReferenceCitation: Chabriat H, Bassetti CL, Marx U, Audoli-Inthavong ML, Sors A, Lambert E, Wattez M, Hermann DM; RESTORE BRAIN study investigators. Safety and efficacy of GABA(A) α5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2020 Mar;19(3):226-233. doi: 10.1016/S1474-4422(20)30004-1.

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

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Sweden
Hungary
Korea, Republic of
France
Belgium
Germany
Czechia

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz Neurologiai Osztaly

location_facility: Gosford Hospital Neurosciences Department

location_facility: Hôpital Sainte-Anne Service de Neurologie

location_facility: H. Virgen del Rocío Servicio de Neurología

location_facility: Hôpital Sud-Francilien Unité Neurovasculaire

location_facility: B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly

location_facility: Royal United Hospital Older People's Unit

location_facility: Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Klinik und Poliklinik für

location_facility: Istituto Neurologico mediterraneo NEUROMED Dipartimento di Medicina Riabilitativa e Specialistica Repar

location_facility: Kreisklinikum Siegen Klinik fuer Neurologie

location_facility: Dong-A University Medical Center Department of Neurology

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo Ambulatório de Neurologia

location_facility: Royal Melbourne Hospital Department of Neurology

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet Neurologiai Osztaly

location_facility: Canisius Wilhelmina Ziekenhuis Afdeling Neurologie

location_facility: Hospital Carlos Fernando Malzone Departamento de Neurologia

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Monash Medical Centre Department of Neurology

location_facility: Universitätsklinikum Erlangen Neurologische Klinik

location_facility: Policlinico Umberto I Emergency Department Stroke Unit

location_facility: Seoul National University Bundang Hospital Department of Orthopaedic

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Oddzial Neurologii

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Szpital Specjalistyczny sw. Lukasza Oddzial Neurologii i Oddzial Udarowy

location_facility: St George's University Hospitals Stroke Research office

location_facility: Hassleholms Sjukhus Stroke- och rehabiliteringsavdelningen 9

location_facility: H. Germans Trias I Pujol Servicio de Neurología

location_facility: Johannes Wesling Klinik Minden Klinik für Neurologie

location_facility: University Hospital Department of Neurology

location_facility: Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii

location_facility: H. Valle de Hebrón Servicio de Neurología

location_facility: Miejskie Centrum Medyczne Jonscher Szpital Dr K. Jonschera

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

location_facility: M. Kopernika Provincial Specialist Hospital Dpt of Neurology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgy Albert Klinikai Kozpont

location_facility: Sint Andries Ziekenhuis Dienst Neurologie

location_facility: Clínica Neurológica e Neurocirúrgica de Joinville

location_facility: Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy

location_facility: Kyungpook National University Hospital Department of Neurology

location_facility: Hôpital Lariboisière, Fernand-Vidal Service de Neurologie

location_facility: Josa Andras Oktatokorhaz Neurologiai Osztaly

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Fakultni nemocnice Brno Neurologicka klinika

location_facility: Universitätsklinikum Ulm Neurologische Klinik (RKU)

location_facility: Universitaetsklinikum Essen Neurologische Universitätsklinik Essen

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica RS Setor de Pesquisa Clínica

location_facility: Royal Stoke University Hospital Stroke Team Office

location_facility: CHU Bdx-Hôpital Pellegrin-Tripode Service de Neurologie

location_facility: Akademiska Sjukhuset Strokeavdelningen 85B

location_facility: Ospedale Sacro Cuore Don Calabria Negrar NEUROLOGY DEPT

location_facility: Ospedale San Giuseppe UOC di Neurologia e Stroke Unit

location_facility: H. Clinic de Barcelona Comprehensive Stroke Center

location_facility: Hospital Universitari de Bellvitge Servicio de Neurología-Unidad de Ictus-Planta 9

location_facility: Hospital Universitario La Fe Servicio de Neurología

location_facility: Klinikum Altenburger Land GmbH Neurologische Klinik

location_facility: Leicester Royal Infirmary Dpt of Neurology

location_facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Hospital Quinta D'or Departamento de Neurologia

location_facility: CHU-Hôpital de la Milétrie Service de Neurologie

location_facility: H. Universitario La Princesa Servicio de Neurología

location_facility: Kanizsai Dorottya Korhaz Neurologiai Osztaly

location_facility: CHU-Hôpital Gui de Chaulliac Unité de Neuropshysiologie Clinique

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Neurologiai Klinika

location_facility: Hospital das Clinicas da Fac. de med. de Ribeirao Preto Unidade de Emergiancia

location_facility: Wojewodzki Szpital Specjalistyczny SPZOZ nr 3 w Rybniku

location_facility: CHRU-Hôpital Roger Salengro Service de Neurologie

location_facility: H. Universitario de Donosti Servicio de Neurología

location_facility: Royal Adelaide Hospital Department of Neurology

location_facility: Zuyderland Medisch Centrum Afdeling Neurologie

location_facility: Chonnam National University Hospital Department of Neurology

location_facility: Lyell McEwin Hospital Neurology Department

location_facility: Soproni Erzsebet Oktato Korhaz Neurologiai Osztaly

location_facility: IMV Pesquisa Neurológica Setor de Pesquisa Clinica

location_facility: H. General de Albacete Servicio de Neurología

location_facility: UNIFESP - Universidade Federal de Sao Paulo Centro de Pesquisa em Neurologia

location_facility: Universitätsklinik der Eberhard-Karls Universtiät Tübingen Hertie-Institut für Klinische Hirnforschung

location_facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

location_facility: Fakultni nemocnice u sv. Anny Neurologicka klinika

location_facility: Vseobecna fakultni nemocnice II. interni klinika VFN a 1. LF UK

location_facility: Royal Brisbane & Women's Hospital Department of Neurology

location_facility: ASAN Medical Center Department of Neurology

location_facility: Hospital das Clinicas da Fac. de Med. de Ribeirao Preto Unidade de Emergencia - Centro de Estudo

location_facility: Vivantes Klinikum Neukölln Klinik für Neurologie mit Stroke Unit


acronym: Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non Dialysis (ASCEND-ND)

title: A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

ReferenceCitation: Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Więcek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.

ReferenceCitation: Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Colombia
Netherlands

summary: The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.


title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Poland
Russian Federation
Argentina
Turkey
Mexico
Brazil
Canada
Switzerland
Hungary
Germany
Greece
France
Chile
Netherlands

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Kentucky One Health St. Joseph East Cancer Center

location_facility: Gene Upshaw Memorial Tahoe Forest Cancer Center

location_facility: Azienda Ospedaliera Universitaria Senese

summary: A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.


title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

acronym: CHARM

summary:
The primary objective of Part 1 of the study is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI). The secondary objectives of Part 1 of the study are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI.

The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Czechia
Portugal
Russian Federation
Australia
Israel
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France

location_facility:
Research SIte
Reseach Site
Research Site
Reserch Site


acronym: CheckMate 647

title: A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)

location_country:
Brazil
Hong Kong
Italy
Russian Federation
Canada
Hungary
France
United States
Israel
Singapore
Japan
Germany
Czechia

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: H. Lee Moffitt Cancer Center & Research Inst, Inc

location_facility: I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze

summary: The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)


acronym: Galahad

title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Ståhl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.

location_country:
Denmark
Taiwan
Brazil
Spain
United Kingdom
Russian Federation
Australia
Canada
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Netherlands

summary: The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.


title: NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug

acronym: NIMES-ROC

summary: Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug

study_type: Observational

time_perspective: Prospective

lead_sponsor: PharmaMar

location_country: Spain Italy France Belgium Germany

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin

location_facility: Strasbourg Oncologie Libérale Centre de radiothérapie

location_facility: Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula

location_facility: Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Policlinico Universitario Agostino Gemelli Università Cattolica di Roma

location_facility: Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde

location_facility: Centre d'Oncologie et de Radiothérapie du Parc

location_facility: Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie

location_facility: Institut d'Oncologie Hauts-de-Seine Nord


title: A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: CheckMate 714

summary: A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Belgium
Czechia
Russian Federation
Argentina
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Ireland
Finland
France
Chile
Netherlands

location_facility: CHU de Quebec - Universite Laval - Hopital de l'Enfant Jesus

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: Centro de Investigacion Pergamino SA- Clinica Pergamino

location_facility: Istituto Nazionale Tumori Fondazione Pascale


title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)

acronym: CLEAR

summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review [IIR] using Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

ReferenceCitation: Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study. Lancet Oncol. 2022 Jun;23(6):768-780. doi: 10.1016/S1470-2045(22)00212-1. Epub 2022 Apr 27.

ReferenceCitation: Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, Grünwald V, Hutson TE, Kopyltsov E, Méndez-Vidal MJ, Kozlov V, Alyasova A, Hong SH, Kapoor A, Alonso Gordoa T, Merchan JR, Winquist E, Maroto P, Goh JC, Kim M, Gurney H, Patel V, Peer A, Procopio G, Takagi T, Melichar B, Rolland F, De Giorgi U, Wong S, Bedke J, Schmidinger M, Dutcus CE, Smith AD, Dutta L, Mody K, Perini RF, Xing D, Choueiri TK; CLEAR Trial Investigators. Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma. N Engl J Med. 2021 Apr 8;384(14):1289-1300. doi: 10.1056/NEJMoa2035716. Epub 2021 Feb 13.

ReferenceCitation: Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10:CD012796. doi: 10.1002/14651858.CD012796.pub2.

lead_sponsor: Eisai Inc.

location_country:
Poland
Spain
Greece
Austria
Australia
Ireland
Canada
Italy
Netherlands
Russian Federation
Switzerland
Korea, Republic of
United States
France
Israel
United Kingdom
Belgium
Japan
Germany
Czechia

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

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

location_facility: SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie

location_facility: Fakultni nemocnice Olomouc, Neurologicka klinika

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Florida Cancer Specialists ( North Region)

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Asan Medical Center: Medical Oncology Department

location_facility: Department of Internal Medicine Division of Hematology/Oncology Cancer center 11F

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Oncology

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: FBHI Privolzhskiy District Medical Centre FMBA of Russia

location_facility: Krankenhaus der barmherzigen Schwestern Linz

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Clinico San Carlos

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Azienda Ospedaliera Santa Maria Degli Angeli

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Adelaide and Meath Hospital Incorp The National Children's Hospital

location_facility: Sunnybrook Research Institute - University of Toronto

location_facility: FSBI "National Medical Research Radiological Center" of the MoH of the RF

location_facility: ICO l'Hospitalet - Hospital Duran I Reynals

location_facility: Institut Regional du Cancer de Montpellier

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin - Department of Urology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Hospital Universitario Central de Asturias

location_facility: Mission Hospital_ Cancer Care of Western North Carolina

location_facility: Weill Cornell Medical College New York Presbyterian Hospital

location_facility: SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"

location_facility: FSBI "Moscow scientific research oncology institute n.a. P.A. Gertsen" of MoH of RF


title: Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

acronym: OPAL

summary: The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.

lead_sponsor: Janssen Biotech, Inc.

location_country:
Spain
Greece
Austria
Canada
Korea, Republic of
United States
France
Germany
Czechia