acronym: Spotlight

title: A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

lead_sponsor: Astellas Pharma Global Development, Inc.

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

location_country:
Poland
Taiwan
Brazil
Spain
Colombia
Italy
Australia
Mexico
Canada
United Kingdom
Korea, Republic of
United States
Chile
China
France
Belgium
Israel
Germany
Peru
Japan

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Angeles Clinic and Research Institute

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: University of Oklahoma Health Science Center

location_facility: Precision Cancer Research -Dayton Physicians Network

location_facility: The University of Arizona Medical Center

location_facility: Rhode Island Hospital-Lifespan Cancer Institute

location_facility: University of Maryland Medical Center(UMMC)Transplant Center

location_facility: The Ohio State University Medical Center

location_facility: University of California - San Francisco

location_facility: Cancer Treatment Centers of America, Atlanta

location_facility: Cancer Treatment Centers of America, Philadelphia

summary:
A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Why is this study being done?

SPOTLIGHT is a new clinical study for adult patients who have any of:

advanced unresectable gastric or GEJ cancer
metastatic gastric or GEJ cancer These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.

For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.

Patients will be assigned to one of two groups by chance and given either:

zolbetuximab with mFOLFOX6; or
a placebo with mFOLFOX6 A placebo is a treatment that looks like the experimental medicine, but contains no medicine.

The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.


type: EudraCT Number

type: Other Identifier

title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus

acronym: STEP

summary: The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Spain
Russian Federation
Australia
Netherlands
Argentina
Ukraine
Sweden
Korea, Republic of
United States
France
Japan
Malaysia
Bulgaria

location_facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Proszowicach

location_facility: Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1

location_facility: Japanese Red Cross Society Nagano Hospital

location_facility: State Health Care Institution of Voronezh region 'Voronezh regional clinical infectious hospital'

location_facility: Japanese Red Cross Nagasaki Genbaku Isahaya Hospital

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: State Health Care Institution 'Engels city hospital #2'

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

location_facility: National Hospital Organization Higashinagoya National Hospital

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: National Hospital Organization Ibarakihigashi

location_facility: Barwon Health - University Hospital Geelong

location_facility: Northwestern University - Northwestern Memorial Hospital - Infectious Disease Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Wojewódzki Szpital Specjalistyczny im. św. Rafała w Czerwonej Górze

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: National Hospital Organization Tenryu Hospital

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

location_facility: Seoul National University Bundang Hospital

location_facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

location_facility: Regional State Health Care Institution 'Clinical Hospital #1'

location_facility: Saint-Petersburg State Public Health Organization City Clinical Hospital #26

location_facility: Saint-Petersburg State Health Care Institution 'Vvedenskaya Hospital'

location_facility: Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: Bukovian State Medical University, Dept. of Infectious Disease and Epidemiology

location_facility: Kharkiv National Medical University, Regional Clinical Infectious Hospital

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika

location_facility: Hospital Privado-Universitario de Cordoba

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Taipei Medical University Shuang Ho Hospital

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

location_facility: Tohoku Medical And Pharmaceutical University Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

acronym: REVERSE

summary: The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

lead_sponsor: Intercept Pharmaceuticals

location_country:
Poland
Spain
United Kingdom
Australia
New Zealand
Canada
Ukraine
Hungary
Puerto Rico
United States
France
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Washington University School of Medicine

location_facility: Carolinas Health Care System Center for Liver Disease

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Walter Reed National Military Medical Center

location_facility: University of California, Davis Medical Center

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Digestive Health Specialists of the Southeast

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department

location_facility: London Health Sciences Centre-University Hospital

location_facility: Carolinas Center for Liver Disease/Carolinas HealthCare System

location_facility: Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours

location_facility: Hospital General Universitario de Valencia

location_facility: Center Hospitalier Universitaire Grenoble Alpes

location_facility: Derby Teaching Hospitals NHS Foundation Trust

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads

location_facility: The University of Texas Medical School at Houston

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Gastroenterology Consultants of Southwest Virginia

location_facility: Synexus Polska Sp. z o.o., Oddział w Łodzi

location_facility: University of California, San Francisco-Fresno

location_facility: Synexus Polska Sp. z o.o., Oddział w Katowicach

location_facility: Synexus Polska Sp. z o.o., Oddział w Warszawie

location_facility: Objective GI d/b/a North Alabama GI Research Center

location_facility: University at Buffalo, Clinical and Translational Research Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Ichan School of Medicine at Mount Sinai Beth Israel

location_facility: Clinique de medecine Urbaine du Quartier Latin

location_facility: Hospital Universitari i Politécnic La Fe

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Synexus Polska Sp. z o.o., Oddział w Poznaniu

location_facility: Nepean Blue Mountains Local Health District, Nepean Hospital

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute

location_facility: Royal Free Hospital NHS Foundation Trust

location_facility: CHU de Rouen-Centre Hospitalier Universitaire

location_facility: Baylor Scott and White All Saints Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Synexus Polska Sp. Z.o.o., Oddział w Gdyni

location_facility: University of Colorado Denver and Hospital

location_facility: Methodist Healthcare University Hospital

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: The University of Vermont Medical Center

location_facility: The Pennsylvania State University and the Milton S. Hershey Medical Center

location_facility: Synexus Polska Sp. z o.o., Oddział w Częstochowie

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Tulane University Health Sciences Center

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Nottingham University Hospitals NHS Trust

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department

location_facility: Chronic Viral Illness/McGill University Health Centre (MUHC)

location_facility: University of North Carolina at Chapel Hill, School of Medicine

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: Diabetes & Endocrinology Consultants, PC

location_facility: Synexus Polska Sp. z o.o., Oddział w Wrocławiu

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

location_facility: Synexus Polska Sp. z.o.o., Oddział w Gdańsku

status_simplified: Completed


title: A Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients Who Have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

ipd_sharing: No

lead_sponsor: Incyte Corporation

location_country:
Denmark
Taiwan
Spain
Ireland
Italy
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Turkey
Japan
Germany

location_facility: Medical University of South Carolina-Hollings Cancer Center

location_facility: University of California Irvine Medical Center

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Clinic of Bashkortostan State Medical University

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Medical Hospital, Tokyo Medical And Dental University

location_facility: Oklahoma Cancer Specialists & Research Institute

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet

location_facility: Marmara Universitesi Pendik Arastirma ve Uyg. Hastanesi

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: National Medical Research Radiological Centre

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Yusen Logistics Co Ltd,. Haneda Logistics Center (MSD DC)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

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

location_facility: Klinikum rechts der Isar der Technischen Universitat

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Hospital Clinico Universitario de Santiago

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

location_facility: University of Tennessee Medical Center Knoxville

location_facility: Severance Hospital Yonsei University Health System

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH


ipd_sharing: Yes

title: A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)

lead_sponsor: Merck KGaA, Darmstadt, Germany

source: euctr

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

location_country:
Denmark
Poland
Portugal
Spain
Greece
Austria
Italy
United Kingdom
Finland
Lithuania
Sweden
Hungary
France
Belgium
Norway
Netherlands
Slovakia
Czechia

location_facility: Hospital Universitario Nuestra Senora de la Candelaria (4776)

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

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

location_facility: GM LCRN - Great Manchester Local Clinical Research Network

location_facility: Hospital General Universitario Gregorio Marañón (5030)

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Azienda Ospedaliera Sant'Andrea Università La Sapienza

location_facility: Vseobecna fakultni nemocnice v Praze (11163)

location_facility: Complejo Hospitalario Universitario de Santiago

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

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Instituto Nazionale Neurologico "Carlo Besta"

location_facility: Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: Centre hospitalier de la Côte Basque - Saint Léon

location_facility: Seconda Univesità degli Studi di Napoli, AOU

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Azienda Ospedaliera S. Camillo Forlanini (8025)

location_facility: Centro Hospitalar do Porto E.P.E. Hospital de Santo António

summary: The main purpose of the study is to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) subjects treated with Mavenclad® for 2 years (24 months).


title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) or Placebo in Participants With Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo in participants with cisplatin-ineligible urothelial carcinoma.

location_country:
Poland
Taiwan
Spain
Ireland
Italy
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Ukraine
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: GU Research Network-Urology Cancer Center

location_facility: Medical University of South Carolina-Hollings Cancer Center

location_facility: University of California Irvine Medical Center

location_facility: Krankenhaus der Barmherzigen Brueder Trier

location_facility: Xarxa Assistencial Universitaria Manresa

location_facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Clinic of Bashkortostan State Medical University

location_facility: Consorci Hospitalari Parc Tauli de Sabadell

location_facility: Medical Hospital, Tokyo Medical And Dental University

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Hospital General Universitari Vall d Hebron

location_facility: National Medical Research Radiological Centre

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II

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

location_facility: GLOBE Badania Kliniczne Oddzial we Wroclawiu

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: RMI Sumy Regional Clinical Oncology Dispensary

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Klinikum rechts der Isar der Technischen Universitat

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Moncton Hospital - Horizon Health Network

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC

location_facility: Universitaetsklinikum Schleswig-Holstein. Campus Luebeck

location_facility: Szpital Sw. Elzbiety Mokotowskie Centrum Medyczne

location_facility: University of Tennessee Medical Center Knoxville

location_facility: Severance Hospital Yonsei University Health System

location_facility: Chang Gung Medical Foundation - Kaohsiung

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone


title: A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).

summary: This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561. Review.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Poland
Taiwan
Portugal
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
Korea, Republic of
France
United States
Belgium
Germany
Czechia

status_simplified: Ongoing


ipd_sharing: Undecided

status: Recruiting

acronym: B-FAST

title: A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, Cobo M, Andric Z, Barrios CH, Yamaguchi M, Dansin E, Danchaivijitr P, Johnson M, Novello S, Mathisen MS, Shagan SM, Schleifman E, Wang J, Yan M, Mocci S, Voong D, Fabrizio DA, Shames DS, Riehl T, Gandara DR, Mok T. Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial. Nat Med. 2022 Sep;28(9):1831-1839. doi: 10.1038/s41591-022-01933-w. Epub 2022 Aug 22.

enrollment_type: Anticipated

location_country:
Serbia
Spain
Italy
United States
Costa Rica
Peru
Belgium
Japan
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Panama
Turkey
Mexico
Singapore
Brazil
Canada
China
Germany
Taiwan
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: The Prince Charles Hospital; Oncology Dept.

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

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie

location_facility: Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

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

location_facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

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

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

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: Clinical Oncology Dispensary; Chemotherapy

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: CancerCare Manitoba; Department of Medical Oncology

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

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

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Yonsei University Health System/Severance Hospital

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: National Cancer Centre; Medical Oncology

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Niigata University Medical & Dental Hospital

location_facility: Henry Ford Health System; Hematology/Oncology

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: London Health Sciences Centre · Victoria Hospital; Department of Medicine

location_facility: Hemato Oncología de Panamá Especializada

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Medipol University MF; Oncology Department

location_facility: Hopital Bretonneau; Pneumologie Oncologie

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: University of Kentucky; Markey Cancer Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

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

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Krakowski Szpital Specjalistyczny im.Jana Pawla II

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

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

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Pendik Training and Research Hospital; Medical Oncology

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

summary: This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.


title: A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])

summary: This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Celgene

location_country:
Denmark
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Sweden
France
Belgium
Norway
Germany

location_facility: A.O Bianchi Melacrino Morelli - Presidio Riuniti

location_facility: S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate

location_facility: Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Klinikum Nord, Klinik für Innere Medizin 5

location_facility: Northern Health and Social Care Trust -Antrim Area Hospital

location_facility: Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover

location_facility: Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie

location_facility: MVZ Mitte - Onkologische Schwerpunktpraxis

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

location_facility: UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita

location_facility: Charité - Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Internistische Facharztzentrum mit Dialyse

location_facility: Servizio immunoematologia e medicina trasfusionale-ASP

location_facility: Hôpital privé d'Antony - Ramsay Générale de Santé

location_facility: "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche

location_facility: Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

location_facility: Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust

location_facility: UO di Ematologia Osp. S. Carlo - Potenza

location_facility: South Eastern Health and Social Care Trust - The Ulster Hospital

location_facility: Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL

location_facility: Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano

location_facility: Betsi Cadwaladr University Health Board - Glan Clwyd Hospital

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

location_facility: Southmead Hospital -North Bristol NHS Trust

location_facility: UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Midlands Regional Hospital , Hematology/Oncology

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -

location_facility: Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital

location_facility: Centro di Riferimento Oncologico di Aviano


title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

summary: This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).

ReferenceCitation: O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, López JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.

ReferenceCitation: Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20.

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

lead_sponsor: Amgen

location_country: Denmark Portugal Italy Sweden France Belgium Germany

location_facility: Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Otto von Guericke UniversitÃ¤t Magdeburg

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Deutsches Rotes Kreuz Kliniken Berlin KÃ¶penick

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden

location_facility: Centre Hospitalier RÃ©gional Universitaire de Tours - HÃ´pital Trousseau

location_facility: Centre Hospitalier de Pau - Hopital Francois Mitterrand

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

location_facility: Centres Hospitaliers Jolimont - Hopital de Jolimont

location_facility: Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier

location_facility: Centre for Clinical and Basic Research Ballerup

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Herz-GefÃ¤ÃŸ-Zentrum Nymphenburg am Klinikum Dritter Orden

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Center for Clinical and Basic Research Aalborg

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Cliniques universitaires de Bruxelles Hopital Erasme

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen

location_facility: Center for Clinical and Basic Research Vejle

location_facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Deutsches Herzzentrum MÃ¼nchen des Freistaates Bayern

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Centre Hospitalier Intercommunal Haute Saone

location_facility: Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer

ReferenceCitation: Kotani N, Wilkins JJ, Wade JR, Dang S, Sutaria DS, Yoshida K, Sundrani S, Ding H, Garcia J, Hinton H, Sane R, Chanu P. Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study. Cancer Chemother Pharmacol. 2022 Dec;90(6):511-521. doi: 10.1007/s00280-022-04488-2. Epub 2022 Oct 28.

ReferenceCitation: Sweeney C, Bracarda S, Sternberg CN, Chi KN, Olmos D, Sandhu S, Massard C, Matsubara N, Alekseev B, Parnis F, Atduev V, Buchschacher GL Jr, Gafanov R, Corrales L, Borre M, Stroyakovskiy D, Alves GV, Bournakis E, Puente J, Harle-Yge ML, Gallo J, Chen G, Hanover J, Wongchenko MJ, Garcia J, de Bono JS. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2021 Jul 10;398(10295):131-142. doi: 10.1016/S0140-6736(21)00580-8.

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

location_country:
Spain
Italy
United Kingdom
United States
Costa Rica
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Mexico
Norway
Brazil
Canada
Hungary
China
Denmark
Taiwan
Greece
Ireland
Thailand
Korea, Republic of
France

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

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

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: A.O. San Carlo Borromeo; U.O.C. Oncologia

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

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

location_facility: Kaiser Permanente San Diego - Los Angeles

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Miami Cancer Institute of Baptist Health, Inc.

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

location_facility: Centro Medico Culiacan SA de CV; Consultorio Medico 303 B

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

location_facility: Urology Cancer Center & GU Research Network

location_facility: Chang Gung Memorial Hospital-LinKou; Urology

location_facility: Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Sykehuset Østfold Kalnes; Onkologisk seksjon

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: Blokhin Cancer Research Center; Urological Dept

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

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

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

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

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

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: HUC; Servico de Urologia e Transplantacao Renal

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

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: University Hospital of Patras Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Hackensack Univ Medical Center; John Theurer Cancer Ctr

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

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Belinson Medical Center, Division of Oncology

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

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: Royal Wolverhampton hospital; McHale Building

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: Hospital Clinic i Provincial; Servicio de Urología

location_facility: KAOHSIUNG MEDICAL UNI CHUNG-HO HOSPITAL; Dept. Of Urology

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Chaim Sheba medical center, Oncology division

location_facility: Woj. Wielospec. Centrum Onkologii i Traumatologii

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

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

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: China Medical University Hospital; Urology

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Seoul National University Bundang Hospital

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Aarhus Universitetshospital, Urologisk Afd. K

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

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

location_facility: Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

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

summary: The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).


acronym: INBUILD®

title: A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Ogura T, Suda T, Inase N, Nishioka Y, Azuma A, Okamoto M, Takizawa A, Ito T, Rohr KB, Inoue Y. Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases: Further subset analysis from the whole INBUILD trial. Respir Investig. 2022 Nov;60(6):787-797. doi: 10.1016/j.resinv.2022.06.009. Epub 2022 Aug 1.

ReferenceCitation: Cottin V, Martinez FJ, Jenkins RG, Belperio JA, Kitamura H, Molina-Molina M, Tschoepe I, Coeck C, Lievens D, Costabel U. Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. Respir Res. 2022 Apr 7;23(1):85. doi: 10.1186/s12931-022-01974-2.

ReferenceCitation: Swigris JJ, Bushnell DM, Rohr K, Mueller H, Baldwin M, Inoue Y. Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases. BMJ Open Respir Res. 2022 Mar;9(1). pii: e001167. doi: 10.1136/bmjresp-2021-001167.

ReferenceCitation: Inoue Y, Suda T, Kitamura H, Okamoto M, Azuma A, Inase N, Kuwana M, Makino S, Nishioka Y, Ogura T, Takizawa A, Ugai H, Stowasser S, Schlenker-Herceg R, Takeuchi T. Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial. Respir Med. 2021 Oct;187:106574. doi: 10.1016/j.rmed.2021.106574. Epub 2021 Aug 12.

ReferenceCitation: Flaherty KR, Wells AU, Cottin V, Devaraj A, Inoue Y, Richeldi L, Walsh SLF, Kolb M, Koschel D, Moua T, Stowasser S, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial. Eur Respir J. 2022 Mar 17;59(3). pii: 2004538. doi: 10.1183/13993003.04538-2020. Print 2022 Mar.

ReferenceCitation: Maher TM, Brown KK, Kreuter M, Devaraj A, Walsh SLF, Lancaster LH, Belloli EA, Padilla M, Behr J, Goeldner RG, Tetzlaff K, Schlenker-Herceg R, Flaherty KR; INBUILD trial investigators. Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. Eur Respir J. 2022 Feb 3;59(2). pii: 2004587. doi: 10.1183/13993003.04587-2020. Print 2022 Feb.

ReferenceCitation: Cottin V, Richeldi L, Rosas I, Otaola M, Song JW, Tomassetti S, Wijsenbeek M, Schmitz M, Coeck C, Stowasser S, Schlenker-Herceg R, Kolb M; INBUILD Trial Investigators. Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Respir Res. 2021 Mar 16;22(1):84. doi: 10.1186/s12931-021-01668-1.

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6). pii: 2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

ReferenceCitation: Wells AU, Flaherty KR, Brown KK, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts WA, Stowasser S, Quaresma M, Goeldner RG, Schlenker-Herceg R, Kolb M; INBUILD trial investigators. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020 May;8(5):453-460. doi: 10.1016/S2213-2600(20)30036-9. Epub 2020 Mar 5.

ReferenceCitation: Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29.

ReferenceCitation: Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg R. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017.

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Argentina
Canada
Korea, Republic of
United States
Chile
China
France
Belgium
Japan
Germany

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: Kobe City Medical Center General Hospital

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

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

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: The First Hospital of Chinese Medical University

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: University of Maryland School of Medicine

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: University of Florida College of Medicine

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Scientific Research Institute of Pulmonology

location_facility: The Ohio State University Wexner Medical Center

location_facility: Pulmonology Scientific Research Institute

location_facility: University of Utah Health Sciences Center

location_facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: National Hospital Organization Himeji Medical Center

summary: The aim of the current study is to investigate the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as patients who present with features of diffuse fibrosing lung disease of >10% extent on high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment with unapproved medications used in clinical practice to treat ILD. There is currently no efficacious treatment available for PF-ILD. Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated that Nintedanib will be a new treatment option for patients with PF-ILD.


title: A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

summary: The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

ReferenceCitation: Roubaud G, Özgüroğlu M, Penel N, Matsubara N, Mehra N, Kolinsky MP, Procopio G, Feyerabend S, Joung JY, Gravis G, Nishimura K, Gedye C, Padua C, Shore N, Thiery-Vuillemin A, Saad F, van Alphen R, Carducci MA, Desai C, Brickel N, Poehlein C, Del Rosario P, Fizazi K. Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study. Eur J Cancer. 2022 Jul;170:73-84. doi: 10.1016/j.ejca.2022.04.016. Epub 2022 May 19.

ReferenceCitation: Matsubara N, Nishimura K, Kawakami S, Joung JY, Uemura H, Goto T, Kwon TG, Sugimoto M, Kato M, Wang SS, Pang ST, Chen CH, Fujita T, Nii M, Shen L, Dujka M, Hussain M, de Bono J. Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis. Jpn J Clin Oncol. 2022 May 5;52(5):441-448. doi: 10.1093/jjco/hyac015.

ReferenceCitation: Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. doi: 10.1016/S1470-2045(22)00017-1. Epub 2022 Feb 11. Erratum in: Lancet Oncol. 2022 Apr;23(4):e161.

ReferenceCitation: Hussain M, Corcoran C, Sibilla C, Fizazi K, Saad F, Shore N, Sandhu S, Mateo J, Olmos D, Mehra N, Kolinsky MP, Roubaud G, Özgüroǧlu M, Matsubara N, Gedye C, Choi YD, Padua C, Kohlmann A, Huisden R, Elvin JA, Kang J, Adelman CA, Allen A, Poehlein C, de Bono J. Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib). Clin Cancer Res. 2022 Apr 14;28(8):1518-1530. doi: 10.1158/1078-0432.CCR-21-3940.

ReferenceCitation: Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Özgüroğlu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. doi: 10.1056/NEJMoa2022485. Epub 2020 Sep 20.

ReferenceCitation: de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28.

location_country:
Denmark
Taiwan
Brazil
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Norway
Turkey
Japan
Germany


title: Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation

summary:
When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.

Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters.

Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

ReferenceCitation: Van Mieghem NM, Unverdorben M, Hengstenberg C, Möllmann H, Mehran R, López-Otero D, Nombela-Franco L, Moreno R, Nordbeck P, Thiele H, Lang I, Zamorano JL, Shawl F, Yamamoto M, Watanabe Y, Hayashida K, Hambrecht R, Meincke F, Vranckx P, Jin J, Boersma E, Rodés-Cabau J, Ohlmann P, Capranzano P, Kim HS, Pilgrim T, Anderson R, Baber U, Duggal A, Laeis P, Lanz H, Chen C, Valgimigli M, Veltkamp R, Saito S, Dangas GD; ENVISAGE-TAVI AF Investigators. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med. 2021 Dec 2;385(23):2150-2160. doi: 10.1056/NEJMoa2111016. Epub 2021 Aug 28.

ReferenceCitation: Giacoppo D. Anticoagulation After Transcatheter Aortic Valve Replacement: Evolving Answers and Still Unaddressed Questions. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1714-1716. doi: 10.1016/j.jcin.2021.06.004. Epub 2021 Jul 14. Erratum in: JACC Cardiovasc Interv. 2021 Oct 25;14(20):2311-2313.

ReferenceCitation: Van Mieghem NM, Unverdorben M, Valgimigli M, Mehran R, Boersma E, Baber U, Hengstenberg C, Shi M, Chen C, Saito S, Veltkamp R, Vranckx P, Dangas GD. Edoxaban Versus standard of care and their effects on clinical outcomes in patients having undergone Transcatheter Aortic Valve Implantation in Atrial Fibrillation-Rationale and design of the ENVISAGE-TAVI AF trial. Am Heart J. 2018 Nov;205:63-69. doi: 10.1016/j.ahj.2018.07.006. Epub 2018 Aug 29.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Universitätsklinik für Innere Medizin II

location_facility: Universitatsmedizin Mainz, Zentrum fur Kardiologie

location_facility: Newmarket Cardiac Surgery Research Incorporated

location_facility: Azienda Socio Sanitaria Territoriale di Lecco

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Michigan Heart, St. Joseph Mercy Health System

location_facility: University Hospitals of Leicester NHS Trust

location_facility: ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

location_facility: Universitatsklinikum Essen, Klinik fur Kardiologie

location_facility: A.A Dei Colli Monaldi UOC Cardiologia Interventistica

location_facility: Complexo hospitalario universitario de Santiago de Compostela

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: ASST Ovest Milanese - Presidio Ospedallero di Legnana

location_facility: University of Arizona Sarver Heart Center

location_facility: Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie

location_facility: Penn State Health, Milton S. Hershey Medical Center

location_facility: Oxford University Hospitals, John Radcliffe Hospital

location_facility: Doylestown Health Cardiothoracic Surgery

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Heart Center Dresden, University Clinic Technical University Dresden

location_facility: University of Massachusetts Memorial Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital Clinico y Provincial de Barcelona

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: University of Texas Health Science Center Houston

location_facility: Universitaetsklinik Schleswig-Holstein Campus Kiel

location_facility: Hospital General Universitario de Alicante

location_facility: Universitaetsklinik fuer Innere Medizin III

location_facility: Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Clinique du Millenaire Service de Cardiologie Interventionelle

location_facility: University of California - San Francisco

location_facility: Complexo Hospitalario Universitario de A Coruna

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III

location_facility: University of Iowa Hospitals and Clinics

location_facility: NY Presbyterian - Brooklyn Methodist Hospital

location_facility: ASST Spedali Civili di Brescia-UO Cardiologia

location_facility: AOU Careggi, Interventistica Cardiologica Strutturale

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Providence Sacred Heart Medical Research Center

location_facility: Hospital Universitario Central de Asturias

location_facility: University Hospital of Wales, Heath Park

location_facility: Asklepios St. Georg Abteilung fuer Kardiologie


intervention_type: Other

title: A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

lead_sponsor: Shire

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Singapore
Canada
Switzerland
Hungary
China
Germany
Greece
New Zealand
Korea, Republic of
France

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Ospedale Infantile Regina Margherita - INCIPIT - PIN

location_facility: VA Puget Sound Health Care System - NAVREF - PPDS

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Martin Luther Universitat Halle Wittenberg

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Kirov Research Institute of Haematology and Blood Transfusion

location_facility: Southampton University Hospitals NHS Trust

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Maryland School of Medicine

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS

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

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Joan and sandford I. Weill Medical College of Cornell University Clinic

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

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

location_facility: Nanfang Hospital Southern Medical University

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: First St. Petersburg State Medical University n.a. I.P Pavlov

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Xiangya Hospital Central South University

location_facility: MTZ Clinical Research Sp z o o - PRATIA - PPDS

location_facility: ICO l'Hospitalet Hospital Duran i Reynals

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

location_facility: Saint Davids South Austin Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

summary:
This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir.

Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it.

After treatment, each participant will be followed up for up to 12 weeks.

Participants will visit their study clinic up to 18 times during the study.


title: A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

acronym: EMINENT

summary: The EMINENT study is a prospective, multi-center study confirming the superior effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

ReferenceCitation: Gouëffic Y, Torsello G, Zeller T, Esposito G, Vermassen F, Hausegger KA, Tepe G, Thieme M, Gschwandtner M, Kahlberg A, Schindewolf M, Sapoval M, Diaz-Cartelle J, Stavroulakis K; EMINENT Investigators. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Circulation. 2022 Oct 18:101161CIRCULATIONAHA122059606. doi: 10.1161/CIRCULATIONAHA.122.059606. [Epub ahead of print]

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Switzerland
France
Belgium
Germany

location_facility: Manchester University NHS Foundation Trust

location_facility: University Hospital Schleswig-Holstein Campus Kiel

location_facility: University Medical Center of Johannes Gutenberg-Mainz

location_facility: Krankenhäuser Landkreis Freudenstadt GmbH

location_facility: Klinikum Nordoberpfalz AG, Klinikum Weiden

intervention_type: Device


title: An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: CheckMate 651

summary: The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

ReferenceCitation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. Erratum in: Lancet Oncol. 2021 Apr;22(4):e134.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Austria
Australia
Ireland
Italy
United Kingdom
Switzerland
Korea, Republic of
United States
France
Israel
Mexico
Japan
Germany

location_facility:
Local Institution - 0068
Local Institution - 0148
Local Institution - 0078
Local Institution - 0036
Local Institution - 0138
Local Institution - 0127
Local Institution - 0128
Local Institution - 0069
Local Institution - 0033
Local Institution - 0042
Local Institution - 0076
Local Institution - 0075
Local Institution - 0026
Local Institution - 0073
Local Institution - 0108
Local Institution - 0100
Local Institution - 0001
Local Institution - 0081
Local Institution - 0019
Local Institution - 0149
Local Institution - 0013
Local Institution - 0097
Local Institution - 0050
Local Institution - 0066
Local Institution - 0043
Beth Israel Deaconess Medical Center
University Of Virginia Health System
Local Institution - 0124
Local Institution - 0077
Local Institution - 0117
Local Institution - 0070
Local Institution - 0006
Local Institution - 0147
Local Institution - 0022
Local Institution - 0107
Local Institution - 0106
Local Institution - 0139
Local Institution - 0040
Local Institution - 0062
Local Institution - 0131
Local Institution - 0122
Local Institution - 0071
Local Institution - 0102
Local Institution - 0141
Local Institution - 0034
Local Institution - 0023
Local Institution - 0115
Local Institution - 0060
Local Institution - 0084
Local Institution - 0109
Local Institution - 0039
Local Institution - 0064
Local Institution - 0035
Local Institution
Local Institution - 0046
Local Institution - 0121
Local Institution - 0055
Local Institution - 0058
Local Institution - 0045
Local Institution - 0004
Local Institution - 0089
Local Institution - 0116
Local Institution - 0104
Local Institution - 0094
Local Institution - 0047
Local Institution - 0135
Local Institution - 0061
Local Institution - 0051
Local Institution - 0015
Local Institution - 0110
St. Mary Medical Center
Local Institution - 0025
Local Institution - 0030
Local Institution - 0082
Local Institution - 0114
Local Institution - 0151
Local Institution - 0101
Local Institution - 0123
Local Institution - 0085
Local Institution - 0028
Local Institution - 0054
Local Institution - 0065
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0007
Local Institution - 0083
Local Institution - 0079
Local Institution - 0063
Local Institution - 0095
Local Institution - 0126
Local Institution - 0072
Local Institution - 0153
Local Institution - 0032
Local Institution - 0017
Local Institution - 0152
Local Institution - 0130
Local Institution - 0049
Local Institution - 0037
Local Institution - 0111
Local Institution - 0012
Local Institution - 0096
Local Institution - 0059
Local Institution - 0113
Local Institution - 0005
Local Institution - 0090
Local Institution - 0125
Local Institution - 0132
Local Institution - 0021
Local Institution - 0105
Local Institution - 0088
Local Institution - 0018
Local Institution - 0098
Local Institution - 0092
Local Institution - 0140
Mass General Hospital
Local Institution - 0134
Local Institution - 0120
Local Institution - 0020
Local Institution - 0031
Local Institution - 0142
Local Institution - 0150
Local Institution - 0146
Local Institution - 0074
Local Institution - 0091
Local Institution - 0118
Local Institution - 0014
Local Institution - 0009
Local Institution - 0044
Local Institution - 0008
Local Institution - 0067

intervention_type: Biological


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

acronym: CheckMate 384

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

location_country:
Spain
Italy
Austria
Australia
Canada
United States
France
Germany

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Tri-County Hematology & Oncology Associates, Inc

location_facility: Southern California Permanente Medical Group

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Kaiser Permanente Medical Center (clinic+DSL)


title: A Multicenter, Randomized, Double-Blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With 131I-Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 mg Daily Will Provide Comparable Efficacy to a 24-mg Starting Dose, But Have a Better Safety Profile

lead_sponsor: Eisai Inc.

ReferenceCitation: Brose MS, Panaseykin Y, Konda B, de la Fouchardiere C, Hughes BGM, Gianoukakis AG, Joo Park Y, Romanov I, Krzyzanowska MK, Leboulleux S, Binder TA, Dutcus C, Xie R, Taylor MH. A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2022 Feb 17;107(3):776-787. doi: 10.1210/clinem/dgab731.

location_country:
Denmark
Poland
Romania
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility:
Facility#1
Royal Brisbane and Women's Hospital
Facility#2
Facility #2
Facility #5
Facility #3
Facility #4
Facility #7
Facility #1
Facility #6

summary: This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.


primary_purpose: Prevention

title: Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

lead_sponsor: GlaxoSmithKline

ReferenceType: background

ReferenceCitation: Ocran-Appiah J, Boutry C, Hervé C, Soni J, Schuind A; ZOSTER-056 Study Group. Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients. Vaccine. 2021 Jan 3;39(1):6-10. doi: 10.1016/j.vaccine.2020.10.029. Epub 2020 Dec 1.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

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

summary: The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).


acronym: JAVELIN Renal 101

title: A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

lead_sponsor: Pfizer

ReferenceCitation: Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3.

ReferenceCitation: Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27.

ReferenceCitation: Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.

ReferenceCitation: Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23. Erratum in: ESMO Open. 2021 Aug;6(4):100177.

ReferenceCitation: Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.

ReferenceCitation: Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.

ReferenceCitation: Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.

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:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Austria
Australia
Russian Federation
Israel
Mexico
Sweden
Canada
Hungary
Germany
Denmark
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Washington University School of Medicine

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: Chungnam National University Hospital, Clinical Pharmacy

location_facility: Sahlgrenska University Hospital, Dept of Oncology

location_facility: Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Clinical Hospital #122 n.a. L. G. Sokolov

location_facility: Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center

location_facility: Seoul National University Bundang Hospital, Clinical Pharmacy

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Netherlands Cancer Institute / Apotheek MC Slotervaart

location_facility: Moffitt Cancer Center and Research Institute

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Investigational Drug Service, University of Pennsylvania

location_facility: Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely

location_facility: Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus

location_facility: Clinical Trial Pharmacy, National Cancer Center

location_facility: Monash Health Translational Precinct, Monash Medical Centre

location_facility: NS HI "Road Clinical Hospital of JSC "Russian Railways""

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,

location_facility: BC Cancer GU Clinic - Fairmont Medical Building

location_facility: East Jefferson Hematology-Oncology Metairie Physician Service Inc.

location_facility: Hospital of the University of Pennsylvania

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - South County

location_facility: CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke

location_facility: Centre Eugene Marquis Service Pharmacie - Essais Cliniques

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer

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

location_facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

location_facility: Novant Health Clinical Research Onocolgy

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

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Niigata University Medical & Dental Hospital

location_facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA

location_facility: LLC "Clinical Diagnostic Center "Medex-pert"

location_facility: Tokyo Women's Medical University Hospital

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters

location_facility: Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy

location_facility: MedStar Health Cardiology Associates, LLC.

location_facility: R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health

location_facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

location_facility: Cleveland Clinic Investigational Pharmacy

location_facility: Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen

location_facility: Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital

location_facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)

location_facility: Mount Vernon Cancer Centre, East & North Herts NHS Trust

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Hirosaki University School of Medicine & Hospital

location_facility: Kyungpook National University Medical Center

location_facility: Department of Medical Oncology, The Christie NHS Foundation Trust

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Winship Cancer Institute, Emory University

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center

location_facility: Krankenhaus der Barmherzigen Schwestern Wien

location_facility: SHI YR Regional Clinical Oncology Hospital

location_facility: Massachusetts General Hospital Clinical Trials Pharmacy

location_facility: Tauranga Hospital, Bay of Plenty Clinical Trials Unit

location_facility: Investigational Drug Service- Emory University

location_facility: Beth Israel Deaconess Medical Center Pharmacy - BIDMC

location_facility: FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF

location_facility: Seoul National University Hospital, Clinical Pharmacy

location_facility: Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital

location_facility: Ballarat Oncology & Haematology Services

location_facility: Washington University Infusion Center Pharmacy

location_facility: Seoul National University Bundang Hospital

location_facility: Kyungpook National University Medical Center, Clinical Pharmacy

location_facility: Barnes-Jewish Hospital, Siteman Cancer Center - West County

location_facility: British Columbia Cancer Agency - Kelowna

location_facility: Russian Research Center for Radiology and Surgical Technologies

location_facility: Addenbrooke's Hospital, Central Pharmacy, Level 1

location_facility: Private medical institution "Euromedservice"

location_facility: "Prof. Dr. Ion Chiricuta" Oncology Institute

location_facility: Institut de Cancerologie de Lorraine (ICL)

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone

location_facility: St Bartholomew's Hospital, Barts Health NHS Trust

location_facility: Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: University of Colorado Cancer Center Anschutz Cancer Pavilion

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"

location_facility: SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"

summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma