title: A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

summary: This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

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 requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Japan
Poland
Portugal
Russian Federation
Australia
Turkey
Brazil
Canada
China
Germany
Taiwan
Thailand
Vietnam
Korea, Republic of
France
Colombia


type: EudraCT Number

type: Registry Identifier

title: A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

summary: The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Greece
Italy
Australia
United Kingdom
Argentina
Canada
United States
France
Netherlands

location_facility: Arizona Oncology - Tucson - Wilmot Road Location

location_facility: Columbia University Medical Center Herbert Irving Pavilion

location_facility: Willamette Valley Cancer Institute And Research Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Medical oncology Hematology Consultants PA, Helen F Graham Cancer Center

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

location_facility: Texas Oncology - Fort Worth Cancer Center

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition

acronym: MONETTE

summary: Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhibition.

ipd_sharing: Yes

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: AstraZeneca

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


title: A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET

acronym: SORENTO

summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

ipd_sharing: No

lead_sponsor: Camurus AB

location_country:
Romania
Spain
Italy
Netherlands
Canada
Hungary
United States
France
Israel
Belgium
Germany

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale

location_facility: Szegedi Tudományegyetem; I.Belgyógyászati Klinika

location_facility: Mayo Clinic Cancer Center (MCCC) - Phoenix

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Notre-Dame - Hermalle

location_facility: Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)

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

location_facility: Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Charite - UB - CVK - Medizinische Klinik

location_facility: White Plains Hospital - Center for Cancer Care

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - L'Hopital General

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

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

location_facility: Hospital Universitario Central de Asturias

location_facility: Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Hospital Universitario Marques de Valdecilla (HUMV)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

location_facility: CHRU Brest - Hopital Morvan - Institut de Cancerologie et d'Hematologie

location_facility: Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)

location_facility: University of Kentucky (UK) - Markey Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

location_facility: Hospital Universitario Fundación Alcorcón

intervention_type: Drug


title: EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor

summary: The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country: Denmark Poland Portugal Spain Greece Ireland Italy Canada Finland Hungary France Belgium Germany Bulgaria Slovakia Czechia


type: Other Identifier

title: A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma

The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Denmark
Taiwan
Hong Kong
Spain
Italy
Russian Federation
United Kingdom
Argentina
Ukraine
Guatemala
Hungary
Korea, Republic of
United States
Chile
China
Costa Rica
France
Japan
Turkey

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)

location_facility: National Cheng Kung University Hospital ( Site 6004)

location_facility: The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 9008)

location_facility: Institut De Cancerologie De Lorraine ( Site 1010)

location_facility: Nottingham University Hospital NHS Trust ( Site 1910)

location_facility: Institut De Cancerologie De L Ouest ( Site 1003)

location_facility: Harbin Medical University Cancer Hospital ( Site 8009)

location_facility: The Third Xiangya Hospital of Central South University ( Site 8046)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1905)

location_facility: Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)

location_facility: Hospital Universitario General de Asturias ( Site 1601)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)

location_facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)

location_facility: The Second Affiliated Hospital of Anhui Medical University ( Site 8026)

location_facility: National Taiwan University Hospital ( Site 6001)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 1304)

location_facility: Podillya Regional Center of Oncology ( Site 1809)

location_facility: Volyn Regional Oncological Dispensary ( Site 1816)

location_facility: Cambridge University Hospitals NHSFT ( Site 1908)

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 1811)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1806)

location_facility: China Medical University Hospital ( Site 6003)

location_facility: The First Affiliated Hospital of Hainan Medical University ( Site 8042)

location_facility: Shanxi Provincial Cancer Hospital ( Site 8019)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 1712)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)

location_facility: National Cancer Center Hospital East ( Site 9002)

location_facility: Humanitas Research Hospital ( Site 1309)

location_facility: UMASS Memorial Medical Center ( Site 0120)

location_facility: Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)

location_facility: Fujian Provincial Cancer Hospital ( Site 8029)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1203)

location_facility: The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)

location_facility: National Cancer Center Hospital ( Site 9001)

location_facility: The Affiliated Hospital of Xuzhou Medical University ( Site 8015)

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

location_facility: A.O. Universitaria di Modena ( Site 1307)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 9019)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)

location_facility: SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1604)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)

location_facility: Affiliated Hospital of Jining Medical University ( Site 8017)

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

location_facility: Affiliated hospital of Jiangnan university ( Site 8049)

location_facility: Kharkiv Regional Clinical Oncology Center ( Site 1812)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 9010)

location_facility: Johns Hopkins Bayview Medical Center ( Site 0152)

location_facility: SBHI Leningrad Regional Oncology Dispensary ( Site 1502)

location_facility: Korea University Guro Hospital ( Site 5001)

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

location_facility: Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)

location_facility: Centre Georges Francois Leclerc ( Site 1008)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1602)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)

location_facility: Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0132)

location_facility: Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)

location_facility: Taipei Veterans General Hospital ( Site 6006)

location_facility: Ibaraki Prefectural Central Hospital ( Site 9007)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)

location_facility: Seattle Cancer Care Alliance ( Site 0145)

location_facility: Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0412)

location_facility: Weill Cornell Medical College ( Site 0133)

location_facility: Institut du Cancer de Montpellier ( Site 1002)

location_facility: Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 8003)

location_facility: Seoul National University Bundang Hospital ( Site 5006)

location_facility: Orszagos Onkologiai Intezet ( Site 1207)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1607)

location_facility: The Christie NHS Foundation Trust ( Site 1909)

location_facility: James Graham Brown Cancer Center ( Site 0117)

location_facility: Kindai University Hospital- Osakasayama Campus ( Site 9017)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)

location_facility: Osaka General Medical Center ( Site 9018)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1901)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 8041)

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)

location_facility: Medeniyet Universitesi Tip Fakultesi ( Site 1703)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 8035)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0604)

location_facility: Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)

location_facility: Hematology-Oncology Associates of CNY ( Site 0173)

location_facility: Southern Medical University Nanfang Hospital ( Site 8031)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)

location_facility: The Cancer Institute Hospital of JFCR ( Site 9005)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)

location_facility: Osaka International Cancer Institute ( Site 9009)

location_facility: Ninewells Hospital and Medical School ( Site 1907)

location_facility: West China Hospital of Sichuan University ( Site 8048)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)

location_facility: Soluciones Gastrointestinales S.A. ( Site 0607)

location_facility: CHRU de Tours - Hopital Bretonneau ( Site 1018)


title: A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

summary:
The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Russian Federation
Australia
Israel
Turkey
Norway
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Can C

location_facility: NYU Clinical Cancer Center Dept of NYU Clin CancerCenter

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd


type: U.S. NIH Grant/Contract

title: A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients With Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) (BMT CTN 2002)

summary: This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

lead_sponsor: Xenikos

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

location_facility: University of Texas Southwestern Medical Center


title: A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

acronym: BOUQUET

summary: This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

design_allocation: Non-Randomized

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

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Switzerland
Korea, Republic of
United States
France
Turkey
Belgium
Germany
Czechia

location_facility: University of Washington - Seattle Cancer Care Alliance; Medical Oncology

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Pinnacle Health; Harrisburg Hospital Pharmacy

location_facility: Chelyabisnk regional clinical center for oncology and nuclear medicine

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: A.O. U. Consorziale Policlinico di Bari; Oncologia Ginecologica

location_facility: McGill University Health Centre - Glen Site

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

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

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: FSBI "Federal Medical Research Center n.a. V.A.Almazov"

location_facility: I.R.C.C. Candiolo; Oncologia Medica e Ematologia

location_facility: Hôpitaux Universitaires de Genève; Département d'oncologie

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: University of Oklahoma Health Sciences Center; Stephenson Cancer Center

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia


title: A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)

summary: The purpose of the study is the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This is the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

status: Active, not recruiting

primary_purpose: Other

enrollment_type: Actual

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

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

location_country: Denmark Poland Spain Italy Austria Hungary France Netherlands Slovakia Czechia

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ospedale Sant'Andrea Neurologia - Università La Sapienza

location_facility: Instytut Psychiatrii i Neurologii - Dept of Neurology II

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Instituto Nazionale Neurologico "Carlo Besta"

location_facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

location_facility: Policlinico Università della Campania L. Vanvitelli

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

location_facility: Centre hospitalier de la Côte Basque - Saint Léon


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)

summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

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

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Philippines
Poland
Portugal
Slovenia
Russian Federation
Australia
Turkey
Norway
Brazil
Canada
Hungary
China
Germany
Greece
Finland
Korea, Republic of
France
Colombia

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Acibadem University School of Medicine Altunizade Hospital Oncology Service

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly)

location_facility: Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center

location_facility: The Second Affiliated Hospital, Zhejiang University

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: FSBSI "N. N. Blokhin Russian Cancer Research Center"

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: MVZ II Zentrum für Hämatologie und Onkologie der Niels Stensen Kliniken

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

location_facility: Haukeland universitetssjukehus, Avd. for kreftbehandling og medisinsk fysikk

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

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

location_facility: University General Hospital of Heraklion;Internal Medicine-Oncology Clinic

location_facility: Hospital Universitario Quiron Madrid; Servicio de Oncologia

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

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii

location_facility: Sykehuset Østfold Kalnes; Onkologisk seksjon

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi

location_facility: St. Luke's Medical Center; Human Cancer Biobank Research Center

location_facility: Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team

location_facility: Oslo Universitetssykehus HF; Ullevål sykehus

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Centre Alexis Vautrin; Oncologie Medicale

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

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: CHUS (Centre Hospitalier Universitaire de Sherbrooke)

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Ospedale Policlinico San Martino; Ist. di Ricovero e Cura a Carattere Scientifico per l'Oncologia

location_facility: Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: St. Petersburg Clinical Scientific Center of special services medical assis (oncology)

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

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: State Healthcare Institution "Regional Clinical Oncology Dispensary"

location_facility: Zhejiang Provincial People's Hospital; Oncology& Breast

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Cebu Doctors' University Hospital; Research Office

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

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

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center

location_facility: Alexandras General Hospital of Athens; Oncology Department

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

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

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej

intervention_type: Other


title: An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

acronym: PSMAddition

summary: The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.

location_country:
Denmark
Poland
Taiwan
Spain
United Kingdom
Austria
Netherlands
Canada
Switzerland
Sweden
Korea, Republic of
United States
France
China
Singapore
Belgium
Japan
Germany

location_facility: UT Health San Antonio Mays Cancer Center

location_facility: Washington University School of Medicine

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med

location_facility: Anschutz Medical Center Anschutz Medical Campus

location_facility: Northwestern University Northwestern (6)

location_facility: University of Pittsburgh Cancer Institute SC-3

location_facility: University of California Irvine ALS and Neuromuscular

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Texas Oncology Texas Oncology - Plano West

location_facility: Oncology Hematology Associates of Southeast Virginia Roanoke Loc

location_facility: University of Texas Southwestern Medical Center

location_facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Centers

location_facility: Georgetown University/Lombardi Cancer Center


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

summary: To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).

lead_sponsor: Jiangsu HengRui Medicine Co., Ltd.

location_country:
Poland
Taiwan
Spain
United Kingdom
Russian Federation
Australia
Hungary
Korea, Republic of
United States
France
China
Belgium
Czechia

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

location_facility: The Second Hospital Of Anhui Medical University

location_facility: CHA Bundang Medical Center CHA University

location_facility: Genesis Cancer Care-CHURCHILL Hospital Headington

location_facility: Cancer hospital Chinese academy of medical science

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

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie

location_facility: The Urology Surgery department of Zhongshan Hospital

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: The Affiliated Tumor Hospital of Xinjiang Medical University-Department of Urology

location_facility: Bashkortostan Republican Clinical Oncology Dispensary

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital General Universitario Gregorio Marano

location_facility: Urological Associates of Southern Arizona PC

location_facility: San Bernardino Urological Associates Medical Group

location_facility: XiangYa hospital central south university

location_facility: Centre Hospitalier Universitaire de Nimes, Institut de Cancerologie du Gard

location_facility: The Second Affiliated Hospital of Nanchang University-DepartmentDepartment of Urology

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Affiliated Hospital of Guizhou Medical University

location_facility: Desert Hematology Oncology Medical Group Inc

location_facility: Changhai Hospital of Shanghai-Department of Urology

location_facility: The Second Hospital Of TianJin medical University

location_facility: Hospital Clinico Universitario San Carlos

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

location_facility: Fujian Medical University Union Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau

location_facility: Wuxi People's Hospital-Department of Urinary Surgery

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

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Instituto Catalán de Oncología - Hospital Universitario Dr. Josep Trueta

location_facility: Chang Gung Memorial Hospital CGMH - Linkou Branch

location_facility: First Hospital of Shanxi Medical University

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

location_facility: The First affiliatared hospital of Fujian medical university

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: The First Affiliated Hospital Of Anhui Medical University

location_facility: Dolnoslaskie Centrum Onkologii - Lower Silesian Oncology Center

location_facility: Institut Univ du Cancer de Toulouse-Oncopole

location_facility: Szpital Wojewdzki w Koszalinie im. Mikoaja Kopernika

location_facility: The first affiliated hospital of guangxi medical university

location_facility: Regionalny Szpital Specjalistyczny im.dr. Wladyslawa Bieganskiego

location_facility: Shanghai Tenth People's Hospital-Department of Urology

location_facility: West China Hospital of Sichuan University

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan University Hospital NTUH

location_facility: Strasbourg Oncologie Liberale- Clinique Sainte Anne

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University

location_facility: Centre Hospitalier Departemental Vendee CHD

location_facility: Urology Ward 2，Harbin Medical University Cancer Hospital

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Fundacion Instituto Valenciano de Oncologia IVO


title: A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors

summary: This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level.

lead_sponsor: HUYABIO International, LLC.

location_country:
Brazil
Spain
Italy
Austria
Australia
New Zealand
United Kingdom
United States
France
South Africa
Belgium
Germany
Czechia

location_facility: Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: Universitaetsklinikum Mannheim, Klinik f. Dermatologie, Venerologie, Allergologle,

location_facility: Thomas Jefferson University Medical Oncology Clinic

location_facility: Universitaetsklinikum Freiburg, Klinik fuer Dermatologie und Venerologie

location_facility: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Froedtert Hospital, Medical College of Wisconsin

location_facility: Fakultni nemocnice Ostrava Kozni oddeleni

location_facility: Universitatsklinikum Essen Klinik fur Dermatologie Studienambulanz

location_facility: Vivantes Klinikum Spandau, Dermatologie und Allergologie

location_facility: Helios Klinikum Erfurt, Dermatologie und Allergologie

location_facility: CHRU Lille - Hôpital Claude Huriez, Clinique de Dermatologie

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: California Cancer Associates for Research and Excellence, Inc. (cCARE)

location_facility: Centro Gaúcho Integrado de Oncologia, Hematologia

location_facility: Hospital Universitario Clinico San Carlos

location_facility: A.O.U Senese Policlinico Santa Maria alle Scotte-UOC Immunoterapia Oncologica

location_facility: Studienzentrum Dermao-Onkologie, Universitaetsklinikum Tuebingen

location_facility: Policlinico G.B. Rossi-Borgo Roma-Centro Ricerche Cliniche di Verona

location_facility: Hospital Regional Universitario de Málaga

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Hautklinik

location_facility: Edinburgh Cancer Center Western General Hospital

location_facility: Hospital Universitario Fundación Jimenez Diaz

location_facility: Institut Gustave Roussy, Service de Dermatologie

location_facility: ICO Badalona-Hospital Universitari Germans Trias I Pujol

location_facility: Medical University of Graz Department of Dermatology and Venerology

location_facility: Cape Town Oncology Trials Cape Gate Oncology Centre

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Univ.-Lkinik für Dermatologie, Venerologie und Allergologie

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale, Oncologia Medica e Terapia Innovativa

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck

location_facility: Hopital de Câncer de Barretos-Fundação Pio XII

location_facility: Universitaetsklinikum Koeln, Dermatologie und Venerologie,


title: Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)

source: euctr

location_country:
Spain
Italy
United Kingdom
United States
Costa Rica
Belgium
Japan
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Turkey
Canada
Guatemala
China
Germany
Taiwan
Ireland
Korea, Republic of
France
Chile
Colombia

location_facility: National Cheng Kung University Hospital ( Site 2904)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0032)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)

location_facility: Nantong Tumor Hospital-Digestive Oncology ( Site 2464)

location_facility: AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)

location_facility: Hospital Universitario General de Asturias ( Site 1901)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)

location_facility: Georgetown University Medical Center ( Site 0009)

location_facility: Hallym University Sacred Heart Hospital ( Site 2806)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0101)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 2007)

location_facility: Changzhou Cancer Hospital-Department of Oncology ( Site 2458)

location_facility: China Medical University Hospital ( Site 2903)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 2902)

location_facility: James Graham Brown Cancer Center ( Site 0017)

location_facility: CHU UCL Namur Site de Godinne ( Site 1005)

location_facility: National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2446)

location_facility: Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)

location_facility: Ninewells Hospital and Medical School ( Site 2207)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 1808)

location_facility: Princess Margaret Hospital. ( Site 2502)

location_facility: LinYi Cancer Hospital-Gastrology department ( Site 2463)

location_facility: Centre Hospitalier Annecy Genevois ( Site 1117)

location_facility: National Cancer Center Hospital East ( Site 2601)

location_facility: National Cancer Center Hospital ( Site 2602)

location_facility: Severance Hospital Yonsei University Health System ( Site 2800)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 0504)

location_facility: Aichi Cancer Center Hospital ( Site 2603)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 0025)

location_facility: Soluciones Gastrointestinales S.A. ( Site 0706)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 2414)

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

location_facility: The Cancer Institute Hospital of JFCR ( Site 2605)

location_facility: Institut du Cancer Avignon-Provence ( Site 1103)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)

location_facility: First Hospital of Lanzhou University ( Site 2417)

location_facility: Blokhin National Medical Oncology ( Site 1800)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)

location_facility: Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 1502)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2610)

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

location_facility: Klinikum Rechts der Isar der TU Muenchen ( Site 1200)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 0705)

location_facility: Medizinische Hochschule Hannover ( Site 1210)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0003)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0414)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2202)

location_facility: The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment

location_facility: Kobe City Medical Center General Hospital ( Site 2606)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2618)

location_facility: Hamilton Health Sciences - Juravinski Site ( Site 0106)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2612)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: National Taiwan University Hospital ( Site 2901)

location_facility: Korea University Guro Hospital ( Site 2808)

location_facility: Charite Berlin Campus Virchow-Klinikum ( Site 1202)

location_facility: The Christie NHS Foundation Trust ( Site 2209)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)

location_facility: Washington University School of Medicine ( Site 0027)

location_facility: Universitaetsklinikum Regensburg ( Site 1203)

location_facility: Harbin Medical University Cancer Hospital ( Site 2410)

location_facility: Hillel Yaffe Medical Center ( Site 1503)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2000)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)

location_facility: Hollywood Private Hospital-Medical Oncology ( Site 2308)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2420)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1902)

location_facility: UMASS Memorial Medical Center ( Site 0020)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 2201)

location_facility: Centre Georges Francois Leclerc ( Site 1106)

location_facility: Clinica Universidad Catolica del Maule ( Site 0411)

location_facility: Hospital Privado de Cordoba ( Site 0204)

location_facility: Kansai Medical University Hospital ( Site 2622)

location_facility: AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)

location_facility: Humanitas Research Hospital ( Site 1600)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 1603)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 2441)

location_facility: Royal Brisbane and Women s Hospital ( Site 2304)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)

location_facility: Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)

location_facility: Leningrad Regional Oncology Center ( Site 1810)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)

location_facility: Universitaetsklinikum Leipzig ( Site 1211)

location_facility: Instituto Medico Alexander Fleming ( Site 0208)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1907)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)

location_facility: Oncologos del Occidente S.A. ( Site 0525)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1501)

location_facility: Hospital General Gregorio Maranon de Madrid ( Site 1904)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)

location_facility: Osaka International Cancer Institute ( Site 2607)

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1801)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 2204)

location_facility: Seoul National University Bundang Hospital ( Site 2804)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 2447)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)

location_facility: Nanjing Drum Tower Hospital ( Site 2419)

location_facility: Fujian Provincial Cancer Hospital ( Site 2408)

summary:
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.

The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.


title: A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease

lead_sponsor: UCB Biopharma SRL

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

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

summary: The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.


title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

acronym: PROVENT

summary: This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

ReferenceCitation: CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html. Published 2020. Accessed 01 July 2020.

ReferenceCitation: Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP. Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.

ReferenceCitation: Furer V, Rondaan C, Heijstek MW, Agmon-Levin N, van Assen S, Bijl M, Breedveld FC, D'Amelio R, Dougados M, Kapetanovic MC, van Laar JM, de Thurah A, Landewé RB, Molto A, Müller-Ladner U, Schreiber K, Smolar L, Walker J, Warnatz K, Wulffraat NM, Elkayam O. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan;79(1):39-52. doi: 10.1136/annrheumdis-2019-215882. Epub 2019 Aug 14.

ReferenceCitation: Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

ReferenceCitation: Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3). pii: e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.

ReferenceCitation: Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simões EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556. Erratum in: N Engl J Med. 2020 Aug 13;383(7):698.

ReferenceCitation: Lamb EJ, Levey AS, Stevens PE. The Kidney Disease Improving Global Outcomes (KDIGO) guideline update for chronic kidney disease: evolution not revolution. Clin Chem. 2013 Mar;59(3):462-5. doi: 10.1373/clinchem.2012.184259.

ReferenceCitation: Li F. Structure, Function, and Evolution of Coronavirus Spike Proteins. Annu Rev Virol. 2016 Sep 29;3(1):237-261. Epub 2016 Aug 25. Review.

ReferenceCitation: Morand EF, Furie RA. Anifrolumab in Systemic Lupus Erythematosus. Reply. N Engl J Med. 2020 Apr 23;382(17):1666. doi: 10.1056/NEJMc2002191.

ReferenceCitation: Poland GA, Ovsyannikova IG, Kennedy RB. Personalized vaccinology: A review. Vaccine. 2018 Aug 28;36(36):5350-5357. doi: 10.1016/j.vaccine.2017.07.062. Epub 2017 Jul 31. Review.

ReferenceCitation: Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.

ReferenceCitation: Wagner A, Weinberger B. Vaccines to Prevent Infectious Diseases in the Older Population: Immunological Challenges and Future Perspectives. Front Immunol. 2020 Apr 23;11:717. doi: 10.3389/fimmu.2020.00717. eCollection 2020. Review.

ReferenceCitation: WHO. WHO Coronavirus Disease (COVID-19) Dashboard. 2020a.

ReferenceCitation: WHO. WHO R&D Blueprint COVID-19 Therapeutic Trial Synopsis Draft 18 February 2020. https://www.who.int/blueprint/priority-diseases/key-action/COVID19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf. Published 2020b. Accessed 25 September 2020.

ReferenceCitation: Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.

ReferenceCitation: Zimmermann P, Curtis N. Factors That Influence the Immune Response to Vaccination. Clin Microbiol Rev. 2019 Mar 13;32(2). pii: e00084-18. doi: 10.1128/CMR.00084-18. Print 2019 Mar 20. Review.

ReferenceCitation: Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6.

ReferenceType: derived

ReferenceCitation: Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6:CD014945. doi: 10.1002/14651858.CD014945.pub2. Review.

ReferenceCitation: Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A, Yuan Y, Seegobin S, Ellery A, Levinson DJ, Ambery P, Arends RH, Beavon R, Dey K, Garbes P, Kelly EJ, Koh GCKW, Near KA, Padilla KW, Psachoulia K, Sharbaugh A, Streicher K, Pangalos MN, Esser MT; PROVENT Study Group. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022 Jun 9;386(23):2188-2200. doi: 10.1056/NEJMoa2116620. Epub 2022 Apr 20.

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

location_country:
United Kingdom
Spain
United States
France
Belgium


status: Completed

acronym: A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis

title: A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism

study_completion_date_type: Actual

lead_sponsor: Vertex Pharmaceuticals Incorporated

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

location_country: Spain Italy Australia France Belgium Netherlands Czechia

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Azienda Ospedaliero Universitaria Federico II Napoli

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Centre Hospitalier Universitaire De Nantes - G. R. Laennec

summary: This study will evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.

status_simplified: Completed


title: A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study

acronym: TALON Ext

summary:
The purpose of this extension study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective is to assess brolucizumab's potential for long durability up to 20 weeks.

All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study.

The study period is 56 weeks including post-treatment follow-up.

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 review 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 availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/

location_country:
Taiwan
Portugal
Spain
Italy
Australia
Netherlands
Switzerland
Sweden
Korea, Republic of
United States
France
Israel
Malaysia
Belgium
Germany
Czechia


title: A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

summary: Study to determine the effect of the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF) in patients with Primary Biliary Cholangitis (also known as PBC).

ReferenceCitation: Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906.

ReferenceCitation: European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Croatia
Poland
Spain
Greece
Austria
Australia
Estonia
Ireland
Lithuania
Netherlands
United Kingdom
Sweden
Hungary
Korea, Republic of
France
Israel
Belgium
Norway
Germany
Czechia

location_facility: Artroscan s.r.o., Gastroenterologicka ambulance

location_facility: Sebészeti, Transzplantációs és Gasztroenterológiai Klinika, Semmelweis Egyetem, Általános Orvostudományi Kar

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Fundacio Clinic Per La Recerca Biomedica

location_facility: NHS Grampian - Aberdeen Royal Infirmary ARI

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: University of Athens - Hippokration General Hospital

location_facility: Groupe Hospitalier Pitié Salpêtrière - Assistance publique - Hôpitaux de Paris

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

location_facility: Narodowy Instytut Onkologii, Klinika Gastroenterologii Onkologicznej

location_facility: Hospital of Lithuanian University of Health Sciences, Kauno Klinikos

location_facility: Consorcio Hospital General Universitario

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hadassah Ein-Karem Medical Center - Liver unit

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

location_facility: Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa

location_facility: Institute of Cellular Medicine, Newcastle University

location_facility: Universitetet i Oslo - Akershus Universitetssykehus (AHUS)

location_facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Seoul National University Bundang Hospital

location_facility: Hull University Teaching Hospitals NHS Trust


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

acronym: ASPEN

summary: The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

ReferenceCitation: Chalmers JD, Usansky H, Rubino CM, Teper A, Fernandez C, Zou J, Mange KC. Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. Clin Pharmacokinet. 2022 Oct;61(10):1457-1469. doi: 10.1007/s40262-022-01147-w. Epub 2022 Jul 25.

lead_sponsor: Insmed Incorporated

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Mexico
Malaysia
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Latvia
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

summary: The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Poland
Taiwan
Romania
Spain
Italy
Austria
United Kingdom
Finland
Hungary
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Norway
Turkey

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

location_facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Westchester Medical Center Advanced Oncology

location_facility: Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: The First Hospital of Lanzhou University

location_facility: Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

location_facility: The Second Affiliated Hospital of Xi an Jiaotong University

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: Pusan National University Yangsan Hospital

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: National Cheng Kung University (Ncku) Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Augusta University - Medical College of Georgia

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Hospital General Universitario Vall D Hebron

location_facility: A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi

location_facility: Hospital of the University of Occupation and Environmental Health

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

location_facility: New Jersey Hematology Oncology Associates Llc

location_facility: Fujian Medical University Union Hospital

location_facility: Spitalul Clinic Coltea - Clinica Hematologie

location_facility: Xuanwu Hospital Capital Medical University

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: The Second Affiliated Hospital of Kunming Medical University

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

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

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Ondokuz Mayis University Medicine Faculty

location_facility: Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie

location_facility: The Catholic University of Korea Seoul St. Mary?S Hospital

location_facility: The First Hospital of China Medical University

location_facility: Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

location_facility: Univ. Di Roma Facolta Di Armacia E Medicina

location_facility: Advent Health Hendersonville Park Ridge Hospital Hendersonville

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Hospital General Unviersitario de Alicante

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Stamford Hospital - Medical Oncology Hematology

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Harbin Institute of Hematology and Oncology

location_facility: Peking University People'S Hospital (Pkuph) - Institute of Hematology

location_facility: Samson Assuta Ashdod University Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Gazi University Hospital Gazi University Faculty of Medicine

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

location_facility: Morristown Medical Center - Atlantic Health System


ipd_sharing: Undecided

acronym: ELATIVE

title: A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

lead_sponsor: Genfit

location_country:
Brazil
Spain
Italy
United Kingdom
Argentina
Canada
Switzerland
United States
Chile
France
South Africa
Belgium
Turkey
Germany

location_facility: Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary

location_facility: King's College Hospital. King's College NHS Foundation Trust

location_facility: Hospital Universitario Puerta de Hierro -Madrid

location_facility: Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond

location_facility: Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology

location_facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)

location_facility: University of California, Davis Medical Center

location_facility: St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research

location_facility: Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)

location_facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale

location_facility: Intermountain Medical Center - Transplant Services

location_facility: Centro de Investigacion Clinica Universidad Catolica CICUC

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie

location_facility: Medical University of South Carolina- College of Medicine

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)

location_facility: Encore Borland-Groover Clinical Research

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP

location_facility: Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads

location_facility: Carolinas Centre for Liver disease/ Atrium Health

location_facility: Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center

location_facility: Columbia University Medical Center - Center for Liver Disease and Transplantation

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

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

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

location_facility: Center for Gastroenterology and Hepatology (GHZ) Kiel

location_facility: Belfast Health and Social Care Trust-Royal Victoria Hospital

location_facility: ASST Monza - Ospedale San Gerardo, Gastroenterologia

location_facility: The Ohio State University Wexner Medical Center

location_facility: Texas Digestive Disease Consultants dba GI Alliance

location_facility: University of Colorado Denver and Hospital

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia

location_facility: Frimley Health NHS Foundation Trust - Frimley Park Hospital

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital

location_facility: Centro de Investigaciones Clinicas (CIC)

location_facility: The New York-Presbyterian Hospital, David H. Koch Center

location_facility: The University of Texas Southwestern Medical Center-IDS Aston Pharmacy

location_facility: Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.

location_facility: University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition

location_facility: Groote Schuur Hospital, University of Cape Town - Clinical Research Centre

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: CHU Grenoble Alpes - Hôpital Albert Michallon

location_facility: Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre

location_facility: Yale School of Medicine, Digestive Diseases

location_facility: Hospital Universitario Marqués de Valdecilla

summary: The main objective of the study is to evaluate the effect of daily oral administration of 80mg elafibranor on cholestasis (impairment of bile formation and/or bile accumulation) in patients with PBC and inadequate response or intolerance to Ursodeoxycholic Acid (UCDA)


title: A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants

summary:
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study.

Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only.

Participants take BI 1358894, quetiapine, or placebo as tablets twice a day. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine.

Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms.

The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Spain
Russian Federation
Australia
Hungary
United States
France
Japan
Germany
Slovakia
Czechia

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: FSBEI of HE Smolensk State Medical University

location_facility: FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro

location_facility: Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

location_facility: National Center of Neurology and Psychiatry

location_facility: Peninsula Therapeutic and Research Group

location_facility: CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinic

location_facility: Federal State Budget Institution "Mental Health Research Center"

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Global Medical Institutes, LLC, Scranton Medical Institute

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"

location_facility: Specialist Psychiatric Healthcare Centre in Lodz

location_facility: Praxis für Psychiatrie und Psychotherapie

location_facility: The Ohio State University Wexner Medical Center

location_facility: SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"

location_facility: Zentrum für klinische Forschung Dr. Schöll, Dr. Steidl & Kollegen

location_facility: SBHI "Psychiatric Hospital #1 P.P.Kashchenko"

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: University of Kansas School of Medicine-Wichita

location_facility: Hospital Universitario Fundación Alcorcón


status: Terminated

title: A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Spain
Italy
Russian Federation
United Kingdom
France
United States
Belgium
Czechia

location_facility: University of California, Los Angeles (UCLA)

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: Istituto Nazionale Tumori, Fondazione G. Pascale Napoli

location_facility: Fondazione IRCCS - Istituto Tumori Milano

location_facility: Foundation IRCCS Casa Sollievo della Sofferenza

location_facility: VHIO Valle de Hebron Instituto de Oncologia

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Arkangelsk Clinical Oncological Dyspensary

location_facility: Russian Cancer research center n.a. N.N. Blokhin

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: Dept. of Oncology Faculty Hospital Motol

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhina" of the MoH of the RF

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chiara

location_facility: SAHI Republican Clinical Oncology Dispensary

location_facility: Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Kursk Regional Clinical Oncology Dispensary

summary: The purpose of this study is to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.

status_simplified: Unknown


title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2

lead_sponsor: Eli Lilly and Company

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

location_country:
Romania
Spain
Italy
Russian Federation
Mexico
Netherlands
United Kingdom
Puerto Rico
India
United States
France
Belgium
Japan
Germany

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Limited Liability Company University Clinic of headaches

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Spitalul clinic de urgenta pentru copii Sf. Maria

location_facility: Bhaktivedanta Hospital and Research Institute

location_facility: Houston Neurology Clinical & Diagnostic Consultants

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: MemorialCare Health System - Long Beach Medical Center

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: Spitalul Clinic de Urgenta pentru Copii Brasov

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Spezielle Schmerztherapie

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Colorado Springs Neurological Associates

location_facility: New England Regional Headache Center, Inc

location_facility: Seattle Women's: Health, Research, Gynecology

location_facility: Integrated Clinical Trial Services, Inc.

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

location_facility: Pirogov Russian National Research Medical University

location_facility: New England Institute for Clinical Research

location_facility: University of Kentucky Chandler Medical Center

location_facility: Hospital de la Santa Creu I Sant Pau - NEURO

location_facility: Josephson Wallack Munshower Neurology, PC

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Japanese Red Cross Kyoto Daiichi Hospital

location_facility: University of North Carolina School of Medicine - Children's Hospital - Children's Research Institute

location_facility: Fondazione Istituto Neurologico C. Mondino

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Ziekenhuis Oost - Limburg ZOL - Kinderneurologie

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Orange County Research Institute - Ontario

location_facility: Sawai Man Singh Medical College Hospital (SMS Hospital)

location_facility: Children's Hospital of New Orleans LCMC Health

summary: The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.


title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Children Mercy Pediatric Clinical Research Unit

location_facility: PMG Research, Inc. d/b/a PMG Research of Piedmont Care

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Limited Liability Company University Clinic of headaches

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Spitalul clinic de urgenta pentru copii Sf. Maria

location_facility: Bhaktivedanta Hospital and Research Institute

location_facility: Houston Neurology Clinical & Diagnostic Consultants

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: University of Miami Don Suffer Clinical Research Building

location_facility: MemorialCare Health System - Long Beach Medical Center

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: Spitalul Clinic de Urgenta pentru Copii Brasov

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Spezielle Schmerztherapie

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Colorado Springs Neurological Associates

location_facility: New England Regional Headache Center, Inc

location_facility: Integrated Clinical Trial Services, Inc.

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

location_facility: Pirogov Russian National Research Medical University

location_facility: New England Institute for Clinical Research

location_facility: University of Kentucky College of Medicine

summary: The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.