acronym: SELUNE

title: A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
Mauritius
Romania
Japan
Philippines
South Africa
Czechia
Portugal
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Guatemala
China
Germany
Denmark
Taiwan
Greece
Latvia
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia

location_facility: Novartis Investigational Site /Hospital for Special Surgery

location_facility: Novartis Investigational Site /Medical University of South Carolina (MUSC)

location_facility: Ahmed Arif Medical Research Center (AAMRC)

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Feinstein Institute for Medical Research-Northwell Health

location_facility: Novartis Investigational Site /UCLA Division of Rheumatology

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Oklahoma Medical Research Foundation Rheumatology Center of Excellence

location_facility: Novartis Investigational Site /Texas Arthritis Center

location_facility: Center for Arthritis and Rheumatic Diseases

summary: The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).


ipd_sharing: Yes

status: Withdrawn

primary_purpose: Treatment

intervention_type: Biological

title: A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis

study_completion_date_type: Actual

lead_sponsor: CSL Behring

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description:
CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

enrollment_type: Actual

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: Universita Degli Studi Di Bari Aldo Moro

location_facility: Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

location_facility: University Clinical Centre, Medical University of Gdansk

location_facility: Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: Sanatorio Parque S.A y Consultorios Externos Asociados

location_facility: Louisiana State University Health Sciences Center

location_facility: Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP)

location_facility: Lombardi Cancer Center-Georgetown University

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Universita degli Studi di Napoli Federico II

location_facility: University of Pennsylvania - Perelman Center

location_facility: Centro De Estudios De Investigation Basica Y Clinica S.C

location_facility: Centro de Investigacion y Tratamiento Reumatologico S.C.

location_facility: Hospital Universitari Materno Infantil Vall Dhebron

location_facility: Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis

location_facility: John Hunter Hospital / Autoimmune Resource and Research Centre

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Universitaetsmedizin der Johannes Gutenberg

location_facility: Royal Free Hospital-Royal Free London NHS Foundation Trust

location_facility: Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital

location_facility: The University Of Texas Medical School At Houston (Utms)

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion

location_facility: Klinika Dermatologii Szpital im. Dzieciątka Jezus

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Internal Medicine, Nantes University Hospital

location_facility: Centro de Alta Especialidad en Reumatologia

location_facility: Uniwersytecki Szpital Kliniczny W Bialymstoku

location_facility: APRILLUS Asistencia e Investigacion Clinica

summary:
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.

Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

lead_sponsor_type: industriel

status_simplified: Unknown


status: Completed

intervention_type: Other

acronym: Tuscany 2

title: A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

lead_sponsor: Pfizer

type: Other Identifier

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
South Africa
Japan
Poland
Russian Federation
Australia
India
Turkey
Mexico
Slovakia
Hungary
Germany
Bulgaria
Thailand
France
Colombia

location_facility: The University of Chicago Medical Center

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Bulent Ecevit Universitesi Tip Fakultesi

location_facility: Gastroenterology Associates, PA of Greenville

location_facility: Studiengesellschaft BSF UG (haftungsbeschränkt)

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez

location_facility: Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: Medical center of Limited Liability Company "Health Clinic", medical clinical research center

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

location_facility: Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

location_facility: Medical Centre Medical Clinic Blagomed LLC

location_facility: Clinical Hospital named after S.R. Mirotvortsev

location_facility: Grant Medical Foundation, Ruby Hall Clinic

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: University Hospitals Leuven/Department of Gastroenterology

location_facility: Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"

location_facility: The University of Chicago Medical Center (clinic address)

location_facility: Allegiance Internal Medicine and Allegiance Research Specialists

location_facility: Research Institute of Antimicrobial Chemotherapy

location_facility: Endoscopy Facility - Orpington Endoscopy Centre

location_facility: Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC

location_facility: Endoscopy Facility - Spire Little Aston Hospital

location_facility: S.R. Kalla Memorial Gastro & General Hospital

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"

location_facility: MeDiNova North London Quality Research Site

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"

location_facility: Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump

location_facility: Gastroenterology Consultants of San Antonio, PA

location_facility: Perm Clinical Centre of the Federal Medical-Biological Agency

location_facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

location_facility: Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"

location_facility: Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent

location_facility: New York Presbyterian Hospital - Weill Cornell Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Limited Liability Company "Medicinsky Center SibNovoMed"

location_facility: Gastroenterology Associates of Northern VA

location_facility: Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"

location_facility: Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija

location_facility: Clinexpert Tatabanya, Szent Borbala Hospital

location_facility: "ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD

location_facility: Tokyo Medical And Dental University Hospital

location_facility: MeDiNova Northamptonshire Quality Research Site

location_facility: M.S. Ramaiah Medical College and Hospitals

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: IRCCS "Saverio de Bellis", UOC Gastroenterologia

location_facility: Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"

location_facility: Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Chest X-ray Facility - BMI Bishops Wood Hospital

location_facility: Medical Research Center Of Connecticut, LLC

summary: This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

status_simplified: Completed


title: An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B and C), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B and C), to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Taiwan
Spain
Italy
Korea, Republic of
United States
France
China
Puerto Rico
Japan
Germany

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Washington University School of Medicine

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Bethune Hospital of Jilin University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Oncologic Hospital, Puerto Rico Medical Center

location_facility: The Fifth Affiliated Hospital of Guangzhou Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: USC - Norris Comprehensive Cancer Center

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

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: The Second Affiliated Hospital of Kunming Medical University

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

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: West China School of Medicine/West China Hospital, Sichuan University

intervention_type: Drug

status_simplified: Ongoing


acronym: CheckMate 7A8

title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Australia
Canada
Puerto Rico
United States
France
Belgium
Germany

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Northside Hospital,Inc.- Central Research Department

location_facility: Centre de Cancerologie du Grand Montpellier

location_facility: Hospital Clinico Universitario De Valencia

summary: A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer


ipd_sharing: No

title: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

lead_sponsor: Incyte Corporation

ReferenceType: derived

ReferenceCitation: Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.

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

location_facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge

location_facility: University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: Synexus Affiliate - Krakowskie Centrum Medyczne

location_facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie

location_facility: University Hospital " Prof. Dr Stoyan Kirkovich"

location_facility: Center For Dermatology Cosmetic and Laser Surgery

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Hospital La Paz (Hospital Universitario La Paz )

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: IDEI (Instituto de Dermatología Integral).

location_facility: Synexus Polska Sp. Z o.o. Oddział w Częstochowie

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Uci Beckman Laser Institute and Medical Clinic

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Diagnostic Consultative Center II Sofia EOOD

location_facility: Diagnostic Consultative Center Ii Sofia Eood

location_facility: University Hospital Prof Dr Stoyan Kirkovich

location_facility: CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR

location_facility: UCI Health Beckman Laser Institute and Medical Center

summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).


title: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

summary: The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

ReferenceCitation: Leal TA, Ramalingam SS. Neoadjuvant therapy gains FDA approval in non-small cell lung cancer. Cell Rep Med. 2022 Jul 19;3(7):100691. doi: 10.1016/j.xcrm.2022.100691.

ReferenceCitation: Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
Mexico
Brazil
Canada
China
Germany
Taiwan
Ireland
France
Netherlands

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Thomas Jefferson University - Clinical Trials Office-Medical Oncology


status: Active, not recruiting

acronym: CULMINATE

title: A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

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

location_country:
Brazil
Spain
Italy
Russian Federation
Australia
Switzerland
France
Israel
Turkey

location_facility: Ankara University Medical Faculty Hematology Department - Hematology

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

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

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

location_facility: Division of Hematology, Cardarelli Hospital

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Nizhniy Novgorod Region Clinical Hospital

summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.


title: A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia

acronym: SAPPHIRE

summary: The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

ReferenceCitation: Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M, Perl S, Rikte T, Erlandsson F, Perkovic V. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia. Nephrol Dial Transplant. 2022 Jul 26;37(8):1461-1471. doi: 10.1093/ndt/gfab237.

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
Romania
Spain
Italy
Hungary
United States
France
Israel
South Africa
Mexico
Slovakia
Czechia


title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

acronym: MELODY

summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

primary_purpose: Prevention

ReferenceCitation: Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wählby Hamrén U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11.

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


title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation

summary: This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

lead_sponsor: Dizal Pharmaceuticals

location_country:
Taiwan
Spain
Italy
Australia
Korea, Republic of
United States
France
Japan
Malaysia

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: Hospital Regional Universitario de Malaga

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

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Innovative Clinical Research Institute, LLC

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

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

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: CHU de Montpellier Hôpital Arnaud de Villeneuve

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

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

location_facility: Peter MacCallum Cancer Centre - East Melbourne

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: Northwell Health - Centers for Advanced Medicine


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

summary: The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

ReferenceCitation: Bril V, Benatar M, Andersen H, Vissing J, Brock M, Greve B, Kiessling P, Woltering F, Griffin L, Van den Bergh P; MG0002 Investigators. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis: A Phase 2 Randomized Control Trial. Neurology. 2021 Feb 9;96(6):e853-e865. doi: 10.1212/WNL.0000000000011108. Epub 2020 Nov 20.

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.

lead_sponsor: UCB Biopharma SRL

location_country:
Denmark
Poland
Taiwan
Serbia
Spain
Italy
Georgia
Russian Federation
United Kingdom
Canada
Hungary
United States
France
Belgium
Japan
Germany
Czechia


acronym: BREEZE-AD-PEDS

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis

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:
Poland
Taiwan
Brazil
Spain
United Kingdom
Austria
Australia
Russian Federation
Argentina
Hungary
France
India
Israel
Mexico
Japan
Germany
Czechia

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika

location_facility: Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital

location_facility: Dr. D. Y. Patil Medical College & Hospital

location_facility: Tula Regional Clinical Dermatovenerological Dispensary

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Instituto de Neumonología Y Dermatología

location_facility: Dermatology and Ophthalmology Kume Clinic

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: Japan National Hospital Organization Mie Hospital

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: CRI Centro Regiomontano de Investigación

location_facility: Consultorio Privado de la Dra. Villanueva

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

summary: The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.


title: A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

summary: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

location_country:
Poland
Taiwan
Hong Kong
United Kingdom
Italy
Russian Federation
Argentina
Thailand
Korea, Republic of
United States
Chile
China
France
India
Japan
Turkey
Bulgaria


acronym: POWER

title: A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

lead_sponsor: Janssen-Cilag Ltd.

ReferenceCitation: Ten Bokkel Huinink S, Biemans V, Duijvestein M, Pierik M, Hoentjen F, West RL, van der Woude CJ, de Vries AC. Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e783-e788. doi: 10.1097/MEG.0000000000002256.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
United Kingdom
Sweden
Korea, Republic of
United States
France
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Universitätsklinikum Frankfurt/ Medizinische Klinik 1

location_facility: Universitätsklinikum Ulm, Klinik für Innere Medizin II

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Southampton University Hospitals NHS Trust

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Gloucestershire Hospitals NHS Foundation Trust - Cheltenham

location_facility: University of Kentucky Chandler Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Gastroenterology Research of America, LLC

location_facility: Pennine Acute Hospitals-Fairfield General Hospital

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

summary: The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.


acronym: MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC

title: A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

location_country:
Spain
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Ireland
Korea, Republic of
France
Chile
Colombia

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0450)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0251)

location_facility: Royal Marsden Hospital - Fulham Road London ( Site 1609)

location_facility: Oncologos del Occidente S.A. ( Site 0310)

location_facility: Loyola University Medical Center [Maywood, IL] ( Site 1817)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0554)

location_facility: Hospital Universitario La Paz ( Site 1201)

location_facility: National Taiwan University Hospital ( Site 1300)

location_facility: Universitaetsklinikum Hamburg Eppendorf ( Site 0407)

location_facility: University of Kansas Cancer Center ( Site 2004)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1920)

location_facility: UVA Health System - Emily Couric Cancer Center ( Site 1826)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0300)

location_facility: Hospital Universitario Austral ( Site 0009)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0654)

location_facility: Universitaetsklinikum Koeln ( Site 0413)

location_facility: Wake Forest Compenhensive Cancer Center ( Site 2029)

location_facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)

location_facility: National Cancer Center Hospital ( Site 0650)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)

location_facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)

location_facility: Washington University School of Medicine ( Site 1800)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0660)

location_facility: Medizinische Universität Wien ( Site 1903)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 1604)

location_facility: The University of New Mexico Comprehensive Cancer Center ( Site 1882)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)

location_facility: Providence Portland Medical Center ( Site 1843)

location_facility: Tokyo Medical University Hospital ( Site 0659)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0704)

location_facility: Weill Cornell Medical College ( Site 2050)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0355)

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

location_facility: University of Utah, Huntsman Cancer Institute ( Site 1855)

location_facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)

location_facility: Aichi Cancer Center Hospital ( Site 0658)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)

location_facility: Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 1818)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)

location_facility: Fundacion Estudios Clinicos-Oncology ( Site 0017)

location_facility: Hospital Britanico de Buenos Aires ( Site 0012)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 1859)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1206)

location_facility: Clinical oncology dispensary of Dnipro ( Site 1706)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)

location_facility: Kyiv City Clinical Oncology Centre ( Site 1701)

location_facility: Hiroshima University Hospital ( Site 0655)

location_facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)

location_facility: St. Joseph Heritage Healthcare ( Site 1806)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 0935)

location_facility: George Washington University Medical Faculty Associates ( Site 2035)

location_facility: Taichung Veterans General Hospital ( Site 1301)

location_facility: The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1702)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)

location_facility: Chaim Sheba Medical Center. ( Site 0553)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)

location_facility: Yokohama City University Hospital ( Site 0657)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)

location_facility: Northwell Health Cancer Institute ( Site 2030)

location_facility: Instituto de Oncologia de Rosario ( Site 0002)

location_facility: McGill University Health Centre ( Site 0210)

location_facility: Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)

location_facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)

location_facility: Instituto de Oncología Angel Roffo ( Site 0003)

location_facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)

location_facility: National Cancer Center Hospital East ( Site 0661)

location_facility: Universitaetsklinikum Frankfurt ( Site 0403)

location_facility: Rush University Medical Center ( Site 1823)

location_facility: National Cheng Kung University Hospital ( Site 1302)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)

location_facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)

location_facility: Inova Schar Cancer Institute ( Site 2026)

location_facility: University of Southern California Norris Comprehensive Cancer Center ( Site 1850)

location_facility: Oregon Health Sciences University ( Site 1871)

location_facility: Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)

location_facility: University of Massachusetts Memorial Medical Center ( Site 1875)

location_facility: Orlando Health Cancer Institute ( Site 2061)

location_facility: UT Southwestern Medical Center ( Site 1841)

location_facility: Ukrainian Center of Tomotherapy ( Site 1708)

location_facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)

location_facility: Hospital Clinico Universitario de Santiago ( Site 1207)

location_facility: University of Vermont Medical Center ( Site 2009)

location_facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)

location_facility: Hoag Memoriall Hospital Presbyterian ( Site 2056)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0171)

location_facility: Hospital Provincial del Centenario ( Site 0008)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)

location_facility: Severance Hospital, Yonsei University Health System ( Site 0701)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)

location_facility: Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)

location_facility: Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)

location_facility: Hopital Europeen Georges Pompidou ( Site 0358)

location_facility: University of Colorado Cancer Center ( Site 1838)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0165)

location_facility: Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)

location_facility: Universitätsklinikum Schleswig-Holstein ( Site 0411)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1857)

location_facility: Royal Brisbane and Women s Hospital ( Site 0050)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont ( Site 0453)

location_facility: Seoul National University Bundang Hospital ( Site 0703)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0153)

location_facility: Chonnam National University Hwasun Hospital ( Site 0705)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0406)

location_facility: Saint Alphonsus Regional Medical Center ( Site 2021)

location_facility: Orszagos Onkologiai Intezet ( Site 0454)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0550)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)

location_facility: Hospital Aleman Buenos Aires Argentina ( Site 0004)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 2034)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)

location_facility: Centro Regional Integrado de Oncologia ( Site 0160)

location_facility: NorthShore University HealthSystem ( Site 1812)

location_facility: St. Luke's University Health Network ( Site 1801)

location_facility: Centro de Investigacion Clinica del Country ( Site 0304)

summary: This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

summary: The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

lead_sponsor: Rigel Pharmaceuticals

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Czechia
Austria
Australia
Russian Federation
Norway
Canada
Hungary
Germany
Bulgaria
Denmark
Belarus
Georgia
France
Netherlands

location_facility: Institut d'hématologie de Basse Normandie, CHU Caen

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

location_facility: The Royal London Hospital, Bart's Health NHS Trust

location_facility: Texas Oncology - Baylor Research Institute

location_facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

location_facility: "University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski " EAD, Clinic of Clinical Hematology, Department of Clinical Hematology

location_facility: American Oncology Network Vista Oncology Division

location_facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia

location_facility: ASST degli Spedali Civili di Brescia, Ematologia UOC

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Universitätsklinik Innsbruck - Innere Medizin V

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region "City Clinical Hospital №2"

location_facility: Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Aarhus University Hospital - Dept of Hematology

location_facility: University of Leipzig Medical Center, Medical Department I - Haematology and Cell Therapy, Medical Oncology, Hemophilia

location_facility: "Specialized Hospital for Active Treatment of Hematological Diseases" EAD, Sofia, Clinic of Clinical Haematology

location_facility: Ospedale Maggiore, SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina

location_facility: State Budgetary Healthcare Institution of Moscow city "City Clinical Hospital No 40 Department of Healthcare of Moscow city"

location_facility: Clinical Centre of Vojvodina, Clinic for Hematology

location_facility: Cherkasy Regional Oncology Dispensary, Hematology Center

location_facility: Clinical Center Nis, Clinic for Hematology

location_facility: Semmelweis Egyetem, Általános Orvostudományi Kar, I.sz. Belgyógyászati Klinika, Haematológiai Osztály,

location_facility: Princess Alexandra Hospital - Cancer Trials Unit

location_facility: CHU Estaing - Chirurgie digestive et Médecine interne

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: City Clinical Hospital № 4, Hematology Center

location_facility: University Hospital Medical Center "Bezanijska Kosa", Department of Hematology

location_facility: "University Multiprofile Hospital for Active Treatment 'Alexandrovska" EAD, Clinic of Clinical Haematology

location_facility: Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

location_facility: Kyiv City Clinical Hospital №9, hematology department №1

location_facility: Universitair Ziekenhuis Antwerpen - Hematologie

location_facility: The Oncology Institute of Hope and Innovation

location_facility: ULSS8 Berica Ospedale San Bortolo - Unità Operativa Complessa di Ematologia

location_facility: State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

location_facility: Rutgers - Robert Wood Johnson Medical School

location_facility: SCDU Ematologia AOU "Maggiore della Carità"

location_facility: Arizona Oncology Associates, PC--HOPE Division

location_facility: Hospital Universitario y Politecnico La Fe - Servicio de Hematología

location_facility: "University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski" EAD, Pleven, Clinic of Clinical Haematology

location_facility: CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: Fakultni nemocnice Ostrava Klinika hematoonkologie

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Hamilton Health Sciences- McMaster University Medical Centre

location_facility: Marshfield Clinic Cancer Center - Stevens Point

location_facility: East Kent Haemophilia Centre, Kent and Canterbury Hospital

location_facility: Pécsi Tudományegyetem, Klinikai Központ, I.számú Belgyógyászati Klinikai, Hematológiai Tanszék

location_facility: "University Multiprofile Hospital for Active Treatment "Sveta Marina"" EAD, Varna, Clinic of Clinical Haematology


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

summary: This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD).

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

ReferenceCitation: Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001. Review.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
New Zealand
Russian Federation
Switzerland
United States
Chile
France
United Kingdom
Japan
Germany

location_facility: German Center for Neurodegenerative Diseases (DZNE)

location_facility: Washington University School of Medicine

location_facility: CenExel Rocky Mountain Clinical Research, LLC

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen

location_facility: Auckland DHB - Neurlogy Department; Neurology Department

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Uniklinik RWTH Aachen; Klinik für Neurologie

location_facility: Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

location_facility: Aberdeen Royal Infirmary; Medical Genectics

location_facility: Сlinical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy

location_facility: Wellington Hospital; Department of Neurology

location_facility: CHU Angers, Batiement Larrey 2, Neurologie

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: John Hopkins University School of Medicine

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

location_facility: Fundacion Jimenez Diaz; Servicio de Neurología

location_facility: National Hospital For Neurology and Neurosurgery

location_facility: Georgetown University; Research Division, Psychiatry

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

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

location_facility: Hopital Roger Salengro; Service de Neurologie

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

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: WESTMEAD HOSPITAL; Deparment of Neurology

location_facility: University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

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

location_facility: St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration

location_facility: University of California Davis Medical System

location_facility: Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.

location_facility: Hospital Universitario de Badajoz; Servicio de Neurología

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Centro de Trastornos del Movimiento (CETRAM); CETRAM

location_facility: Research Center of Neurology; Neurology Department #5

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique

location_facility: Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit

location_facility: Hopital Henri Mondor; Service de Neurologie

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital

location_facility: Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine

location_facility: George-Huntington- Institut GmbH; Technologiepark Münster

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare

location_facility: University of Utah Clinical Neurosciences Center

location_facility: The University of Texas Health Science Center at Houston; McGovern Medical School

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: National Hospital Organization Niigata National Hospital

location_facility: Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica


acronym: METEORIC-HF

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance

lead_sponsor: Cytokinetics

ReferenceCitation: Lewis GD, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Böhm M, Teerlink JR, Docherty KF, Lopes RD, Divanji PH, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Felker GM. Effect of Omecamtiv Mecarbil on Exercise Capacity in Chronic Heart Failure With Reduced Ejection Fraction: The METEORIC-HF Randomized Clinical Trial. JAMA. 2022 Jul 19;328(3):259-269. doi: 10.1001/jama.2022.11016.

ReferenceCitation: Lewis GD, Docherty KF, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Ponikowski P, Böhm M, Teerlink JR, Heitner SB, Kupfer S, Malik FI, Meng L, Felker GM. Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF. Circ Heart Fail. 2022 May;15(5):e008970. doi: 10.1161/CIRCHEARTFAILURE.121.008970. Epub 2022 Mar 3. Review.

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

location_country:
Poland
Italy
Netherlands
Canada
Sweden
Hungary
United States
France
Germany

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil

location_facility: Glacier View Research Institute, Cardiology

location_facility: Broward Research Center - Pembroke Pines

location_facility: Mcgill University Health Centre (MUHC)-The Montreal General Hospital (MGH)

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Massachusetts General Hospital (MGH) - Cardiac Unit Associates

location_facility: Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer

location_facility: Wake Forest University School of Medicine

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologiczny

location_facility: Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Erasmus MC - Universitair Medisch Centrum Rotterdam

location_facility: Universitair Medisch Centrum Utrecht - Wilhelmina Kinderziekenhuis

location_facility: Universite de Montreal Institut de Cardiologie de Montreal ICM Montreal Heart Institute MHI

location_facility: Divisione di Cardiologia con Utic ed Emodinamica

location_facility: Uniwersyteckie Centrum Kliniczne Kliniczne Centrum Kardiologii

location_facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Hartford Hospital-University of Connecticut School of Medicine

location_facility: University of Texas - Southwestern Medical Center

location_facility: Oddzial Kliniczny Choroby Wiencowej i Niewydolnosci Serca z Pododdzialem Intensywnego Nadzoru Kardiologicznego

location_facility: Baylor Scott and White Heart and Vascular Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

location_facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

location_facility: Centrum Chorob Serca, Uniwersytecki Szpital Kllniczny im. Jana Mikulicza Radeckiego we Wrociawiu

location_facility: London Health Sciences Centre - University Hospital

location_facility: Universite De Nantes - L'Institut Du Thorax

location_facility: Instytut Kardiologii Heart Failure Clinic

location_facility: Enhet Klinisk forskning, hjartmedicin, Skanes Universitet Sjukhus

location_facility: Onze Lieve Vrouwe Gasthuis (OLVG) Locatie West

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

summary: The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo


title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

acronym: CYCLONE 2

summary: This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

location_country:
Denmark
Spain
United Kingdom
Australia
Netherlands
Korea, Republic of
United States
France
China
Romania
Japan
Germany

location_facility: HuaShan Hospital Affiliated To Fudan University

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: Yijishan Hospital of Wannan Medical College

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

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Harbin Medical University Cancer Hospital

location_facility: Associated Medical Professionals - Urology

location_facility: Kobe City Medical Center General Hospital

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

location_facility: St. Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Centre de Cancérologie du Grand Montpellier

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

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Urologie am Nordplatz - Urologische Facharztpraxis Dr. med. Silvio Szymula

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: Urologische Arztpraxis in Eisleben - Dr. med. Ralf Eckert

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Second affiliated hospital of anhui medical university

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: First Affiliated Hosp of College of Med, Zhejiang University


title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)

ReferenceCitation: Tabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Costa Rica
Peru
South Africa
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Switzerland
Guatemala
Hungary
China
Germany
Denmark
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Chile
Colombia

location_facility: University of Debrecen Medical Center Clinic of Oncology ( Site 3300)

location_facility: Peking University Shenzhen Hospital ( Site 2442)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1204)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2611)

location_facility: Cancer Treatment Centers of America - Philadelphia ( Site 0112)

location_facility: National Cheng Kung University Hospital ( Site 2901)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2605)

location_facility: Universitaetsspital Zuerich ( Site 1902)

location_facility: Tallaght University Hospital ( Site 1202)

location_facility: Kobe City Medical Center General Hospital ( Site 2603)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)

location_facility: Kansai Medical University Hospital ( Site 2608)

location_facility: Instituto Nacional de Cancerologia. ( Site 0804)

location_facility: Greater Baltimore Medical Center ( Site 0102)

location_facility: Soroka University Medical Center ( Site 1305)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2015)

location_facility: Clinic of National Cancer Institute ( Site 2203)

location_facility: Fujian Provincial Cancer Hospital ( Site 2414)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)

location_facility: Kitasato University Hospital ( Site 2618)

location_facility: MI Odessa Regional Oncological Centre ( Site 2212)

location_facility: Universitaetsklinikum Leipzig ( Site 1114)

location_facility: Kumamoto University Hospital ( Site 2602)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

location_facility: Fujian Medical University Union Hospital ( Site 2410)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2609)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1614)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

location_facility: Xiangya Hospital Central-South University ( Site 2419)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

location_facility: Minnesota Oncology Hematology, PA ( Site 8000)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0400)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0403)

location_facility: Instituto Medico Alexander Fleming ( Site 0307)

location_facility: Universitas Annex National Hospital ( Site 1701)

location_facility: Cancercare Rondebosch Oncology ( Site 1709)

location_facility: Princess Margaret Hospital. ( Site 2502)

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

location_facility: Masarykuv onkologicky ustav ( Site 3103)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2213)

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)

location_facility: Christus Muguerza Clinica Vidriera ( Site 0802)

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

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

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)

location_facility: Princess Margaret Cancer Centre ( Site 0203)

location_facility: The First Hospital of Jilin University ( Site 2416)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 3104)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)

location_facility: Medical Centre LLC Oncolife ( Site 2202)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1907)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0809)

location_facility: Niigata Cancer Center Hospital ( Site 2613)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 1503)

location_facility: Edith Wolfson Medical Center ( Site 1307)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0500)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)

location_facility: Centro Oncologico Riojano Integral ( Site 0313)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)

location_facility: National Cancer Center Hospital East ( Site 2617)

location_facility: Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)

location_facility: Peking Union Medical College Hospital ( Site 2425)

location_facility: National Cancer Center Hospital ( Site 2606)

location_facility: Zhejiang Provincial People's Hospital ( Site 2446)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0605)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)

location_facility: Hospital Universitario General de Asturias ( Site 1802)

location_facility: University College London Hospital ( Site 1211)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)

location_facility: National Taiwan University Hospital ( Site 2900)

location_facility: The Oncology Centre Overport and Umhlanga ( Site 1705)

location_facility: Fakultni Thomayerova nemocnice ( Site 3101)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)

location_facility: Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)

location_facility: Instituto de Investigaciones Metabolicas ( Site 0312)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0501)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1804)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 1413)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2204)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 1704)

location_facility: Blokhin National Medical Oncology ( Site 1604)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1700)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0604)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1101)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 1616)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0902)

location_facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)

location_facility: Instituto do Cancer do Ceara ( Site 0407)

location_facility: Hospital General Universitario de Elche ( Site 1803)

location_facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1703)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)

location_facility: The Affiliated Hospital of Qingdao University ( Site 2405)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)

location_facility: Zhongshan Hospital Xiamen University ( Site 2447)

location_facility: Orszagos Onkologiai Intezet ( Site 3303)

location_facility: Aichi Cancer Center Hospital ( Site 2619)

location_facility: Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1301)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2612)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)

location_facility: Istituto Europeo di Oncologia ( Site 1411)

location_facility: City Clinical Oncology Center ( Site 1603)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0502)

location_facility: Hospital de Caridade de Ijui ( Site 0402)

location_facility: Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2430)

location_facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

location_facility: Harbin Medical University Cancer Hospital ( Site 2401)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 2440)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

location_facility: Hacettepe University Medical Faculty ( Site 2017)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2610)

location_facility: 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)

location_facility: Aalborg University Hospital ( Site 3204)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1801)

location_facility: Yancheng First People s Hospital ( Site 2426)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 1007)

location_facility: Osaka International Cancer Institute ( Site 2607)

location_facility: Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 2407)

location_facility: Sunnybrook Research Institute ( Site 0202)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 2436)

location_facility: UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0703)

location_facility: Southern Medical Day Care Centre ( Site 2303)

location_facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)

location_facility: Odense Universitets Hospital ( Site 3201)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)

location_facility: McGill University Health Centre ( Site 0208)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)

location_facility: Fundacion Favaloro - Hospital Universitario ( Site 0302)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)

summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.

The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).


title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Oropharyngeal Cancer (OPC)

summary: This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.

lead_sponsor: ISA Pharmaceuticals

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Mexico
Netherlands
Hungary
France
United States
Belgium
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Instituto de Oncologia do Paraná - IOP Pesquisa

location_facility: National Cancer Institute Regina Elena, IRCCS

location_facility: Hospital Universitario Marqués de Valdecilla Santander

location_facility: Maria Sklodowska-Curie National Institute of Oncology

location_facility: ASST Spedali Civili Brescia, Department of Medical Oncology

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: University of Pecs Department of Oncotherapy

location_facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"

location_facility: Instituto COI - Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: University of Cincinnati Cancer Institute

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

location_facility: Robert H. Lurie Comprehensive Cancer Center

location_facility: Centro Integral de Reumatologia S.A. de C.V (CIRSA)

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Revive Research Institute, Inc. - Farmington Hills

location_facility: Hospital Duran i Reynals - Institut Catala dOncologia ICO

location_facility: Instituto do Cancer do Estado de Sao Paulo

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: HSRT, Human Science Research Trials S de RL de C.V

location_facility: FUNFARME Hospital de Base de São José do Rio Preto

location_facility: Hopitaux Universitaires Pitié Salpêtrière Charles Foix

location_facility: Azienda Ospedaliera San Paolo Polo Universitario

location_facility: IKrankenhaus Nordwest gGmbH, nstitut für Klinisch-Onkologische Forschung

location_facility: Nicolaus Copernicus Provincial Multispecialty Oncology

location_facility: UOC Oncologia Medica Ospedale di Sondrio


title: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. Review.

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Canada
Puerto Rico
United States
Chile
France
Singapore
Belgium
Norway
Germany
Czechia

location_facility: Universitatsklinikum Carl Gustav Carus Dresden


title: XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease

summary: The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

ReferenceCitation: Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Portugal
Spain
Greece
Italy
Australia
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: Kortrijk - HOSP AZ Groeninge Kennedylaan

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Regional Universitario de Málaga

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

location_facility: Hematology Oncology Associates of Rockland

location_facility: University Hospital of Larisa, Oncology Clinic

location_facility: University General Hospital of Heraklion

location_facility: Istituto Nazionale IRCCS Tumori Fondazione Pascale

location_facility: Euromedica Kyanous Stavros General Hospital

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: CHU de Quebec-Universite Laval Research Centre


status: Terminated

title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Japan
Poland
Russian Federation
Argentina
Turkey
Mexico
Sweden
Malaysia
Brazil
Hungary
Germany
Bulgaria
Taiwan
Thailand
Korea, Republic of
France

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej

location_facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Hospital de Messejana dr. Carlos Alberto Studart Gomes

location_facility: Department of Pediatrics University of Pavia, Policlinico San Matteo

location_facility: Dipartimento di Pediatria dell'Ospedale Luigi Sacco

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

location_facility: Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii

location_facility: Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy

location_facility: Children Outpatient Clinic 45 Of Nevskiy Region

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

location_facility: Queen Sirikit National Institute of Child Health

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Yaroslavl State Medical University Based On Children Polyclinics #5

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Shirao Clinic of Pediatrics and Pediatric Allergy

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

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

location_facility: City Children Clinical Outpatient Clinic #5

location_facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

location_facility: ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Osrodek Badan Klinicznych In-Vivo Sp. z o.o.

location_facility: Infectious Clinical Hospital #1 Of The Moscow City Health Department

location_facility: Tropical Medicine Hospital, Mahidol University

location_facility: Santa Casa de Misericórdia de Votuporanga

location_facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

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

location_facility: CMPC - Consultoria Médica e Pesquisa Clínica

location_facility: Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Nucleo de Pesquisa do Hospital Pequeno Princípe

location_facility: Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

location_facility: Debreceni Egyetem Klinikai Központ,Infektológiai Klinika

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

summary: The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).


title: An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

acronym: ALITHIOS

summary:
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

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:
Croatia
Spain
United Kingdom
Lithuania
United States
Peru
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
Estonia
Finland
Thailand
France
Netherlands