title: A Multicentre, Phase II, Single-Arm, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy (CT), Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy (CRT) and Consolidation Durvalumab, in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)

acronym: MDT-BRIDGE

summary: The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.

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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Portugal
Hungary
Sweden
Austria
United States
Spain
Czechia
Canada
France


type: Registry Identifier

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

summary: The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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).

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_country:
Germany
New Zealand
Japan
Brazil
Thailand
Turkey
Canada
France
Hong Kong
United States
Belgium
China
Puerto Rico
Italy
Singapore
Korea, Republic of
Spain
South Africa
Taiwan

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

location_facility: Hospital Clinic i Provincial; Servicio de Hepatología

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

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

location_facility: Xi'an Inernational Medical Center Hospital

location_facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi)

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Shengjing Hospital of China Medical University

location_facility: China Medical University Hospital; Surgery

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

location_facility: Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins

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

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Gastroenterologia

location_facility: Christchurch Hospital; Gastroenterology Dept

location_facility: Swedish Cancer Institute - Edmonds Campus

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: Hospital Clinico de Valencia; Servicio de Hepatologia

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: The First Affliated Hospital Of Fujian Medical University; Intervention Department

location_facility: PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center

location_facility: Hospital Universitario de Burgos; Oncología

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo

location_facility: A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Clinica Universitaria de Navarra; Servicio de Hepatologia

location_facility: Chonnam National University Hwasun Hospital

location_facility: Clinica Universitaria de Navarra de Madrid; Servicio de Hepatologia; Servicio de Hepatologia

location_facility: James J Peters VA Hospital / Mental Illness Research Education and Clinic Center

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: West China Hospital - Sichuan University

location_facility: Hospital Universitario Central de Asturias; Servicio de Hepatología

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University

location_facility: National Cheng Kung University Hospital; Oncology

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

location_facility: McGill University Health Centre - Glen Site

location_facility: National Cancer Centre; Medical Oncology

location_facility: Hopital Dupuytren; Hepatologie Gastro Enterologie

location_facility: Hopital Paul Brousse; Centre Hepatologie Biliaire

location_facility: Khon Kaen Uni ; Faculty of Medicine, Division of Gastroenterology

location_facility: Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Capt. James A. Lovell Federal Health Care Center

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

location_facility: Universität Tübingen; Med. Klinik; Innere Medizin I

location_facility: The First Affiliate Hospital of Guangxi Medical University

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

acronym: ProvIDHe

summary: A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

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

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Servier Affaires Médicales

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Spain
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

location_facility: Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf

location_facility: Universiteit Maastricht UM - Maastricht University Medical Centre MUMC

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Casa Sollievo della Sofferenza (CSS)

location_facility: Universitaetsklinik fuer Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum

location_facility: Centre Hospitalier Universitaire de Nantes CHU de Nantes

location_facility: Medizinische Universitaet Wien Universitaetsklinik fuer Innere Medizin I

location_facility: University Hospitals Birmingham (UHB) NHS Foundation Trust - Queen Elizabeth Hospital Birmingham (QEHB)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University College London Hospital NHS Trust

location_facility: Cliniques Univ St Luc - Gastro-Enterology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Medizinische Fakultaet der Universitaet Freiburg

location_facility: Klinikum der Universitaet Muenchen-Grosshadern

location_facility: The Beatson Institute West of Scotland Cancer Research

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Hospital Universitari Vall d'Hebron/Vall Hebron Institute of Oncology (VHIO)


type: Other Identifier

title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

summary: The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

ipd_sharing: No

lead_sponsor: Gilead Sciences

location_country:
Poland
Australia
Brazil
Japan
Czechia
Canada
France
Hong Kong
United States
Belgium
China
Italy
Singapore
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Maria Sklodowska - Curie Institute of Oncology

location_facility: Investigational Drug Services, AdventHealth Orlando

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie

location_facility: Yale-New Haven Hospital-Yale Cancer Center

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

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

location_facility: CHU de Québec-Université Laval, Hôpital du Saint-Sacrement

location_facility: Institut Regional du Cancer de Montpellier

location_facility: National Hospital Organization Hokkaido Cancer Center

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

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universitätsklinik für Innere Medizin 3 der PMU

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Seoul National University Bundang Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute

location_facility: Oncology Institute Rambam Health Care Campus

location_facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Centre Jean Bernard Service d'Oncologie Médicale


title: A Multicentre Randomized, Double-blind, Placebo Controlled, Dose-finding, Phase 2 Study (MARS-17) of GSK3858279 in Adult Participants With Moderate to Severe Pain Due to Knee Osteoarthritis

summary: This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United Kingdom
Argentina
Australia
Japan
Mexico
United States
China
Korea, Republic of
Spain
South Africa
Canada
France


title: Randomised, Double-blind, Placebo-controlled, Phase IIb/Phase III Study to Evaluate the Efficacy and Safety of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa. Lunsayil 1.

summary:
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part.

This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment.

In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment.

Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

ipd_sharing_description:
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms o

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Japan
Chile
Canada
France
Lithuania
Slovakia
Denmark
Switzerland
United States
Belgium
Malaysia
Philippines
Italy
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Israel

location_facility: Vilnius University Hospital, Santariskiu

location_facility: Hospital Raja Perempuan Zainab II, Kota Bharu

location_facility: NSZOZ Termedica Clinical Research Center

location_facility: Hôpitaux Universitaires Genève (HUG) Dermatologie et vénéréologie

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Instituto de Especialidades de la Salud Rosario

location_facility: Istituto Dermopatico Dell'Immacolata - IDI - IRCCS

location_facility: Japan Community Healthcare Organization Chukyo Hospital

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Centro de Investigaciones Médicas Mar del Plata

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Complexo Hospitalario Universitario De Santiago

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Center for Skin Research, Testing and Product Development

location_facility: SimcoDerm Medical and Surgical Dermatology Centre

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: DOST sro - Sanatorium-Type Dermatovenereological Department

location_facility: Centro Internacional de Estudios Clínicos (CIEC)

location_facility: Shiga University of Medical Science Hospital

location_facility: University Hospital Bern/Inselspital Bern

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: York Dermatology Clinic and Research Centre


title: Cold Agglutinin Disease Real World Evidence Registry

acronym: CADENCE

summary: This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

lead_sponsor: Sanofi

location_country:
United States
Italy
Austria
France

location_facility: Orchard Heathcare Research Inc. Site Number : 1202

location_facility: SUNY Upstate Medical University Site Number : 1221

location_facility: Northwell Health-Monter Cancer Center-North Shore University Hospital and Steven and Alexandra Cohen Children's Medical Center of New York (Schneider Children's Hospital)-North Shore Long Island Jewis Site Number : 1231

location_facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220

location_facility: University of Alabama at Birmingham Site Number : 1230

location_facility: Center for Blood Disorders Site Number : 1214

location_facility: SLO Oncology and Hematology Site Number : 1235

location_facility: Hematology Oncology Associates, PC Site Number : 1211

location_facility: Brody School of Medicine at East Carolina University Site Number : 1203

location_facility: Reliant Medical Group Site Number : 1205


title: A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared With Placebo in Patients With Idiopathic Pulmonary Fibrosis and in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease

summary: The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks.

lead_sponsor: Genentech, Inc.

location_country:
Italy
Poland
New Zealand
Israel
Argentina
Brazil
Belgium
United States
Korea, Republic of
Spain
Greece
South Africa
Chile
Taiwan
France

location_facility: Hospital de Clinicas de Porto Alegre HCPA PPDS

location_facility: Hospital Universitario Virgen de la Victoria

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

location_facility: EMED Centrum Uslug Medycznych Ewa Smialek

location_facility: Hannibal Regional Healthcare System HRMG Hannibal

location_facility: University General Hospital of Heraklion

location_facility: Presidio Ospedaliero GB Morgagni L Pierantoni

location_facility: Centro de Investigaciones Reumatologicas

location_facility: IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine

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

location_facility: El Paso Pulmonary Association Elligo PPDS

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: University of California, San Francisco Medical Center

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele


title: A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination With Chemotherapy for the First Line Treatment for Patients With Advanced Biliary Tract Cancers (TOURMALINE)

acronym: TOURMALINE

summary: A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Italy
Singapore
Japan
United States
Korea, Republic of
Spain
France


title: A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

acronym: ROCKET-ASTRO

summary: The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent subjects.

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:
Germany
Poland
Japan
Brazil
Thailand
Chile
Canada
France
Hungary
United States
Romania
Belgium
China
Puerto Rico
Italy
Korea, Republic of
Spain
Greece
Taiwan

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main

location_facility: Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Dalian Women and Childrens Medical Group

location_facility: Centre Hospitalier Universitaire de Toulouse, Hopital Larrey

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Industrial Medicine Associates Clinical Research Advanced Dermatology Care

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz

location_facility: Henry Ford Medical Center - New Center One

location_facility: Cahaba Dermatology and Skin Health Center

location_facility: The Catholic Univ of Korea Seoul St Marys Hospital

location_facility: Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia LTDA

location_facility: Dermatology Research Center of Oklahoma, PLLC

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Childrens Hospital of Chongqing Medical University

location_facility: Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo

location_facility: Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"

location_facility: Dr. Leventer Centre: Clinică Dermatologie București

location_facility: Velocity Clinical Research - Grants Pass

location_facility: Clinical Associates of Orlando Limited Liability Company

location_facility: Center for Dermatology Clinical Research Inc

location_facility: Ippokratio General Hospital of Thessaloniki

location_facility: sms Clinical Research Limited Liability Company

location_facility: The University of Texas Health Science Center at Houston

location_facility: Yeshiva University - Montefiore Medical Center

location_facility: Dermatology and Ophthalmology Kume Clinic

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center

location_facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

location_facility: Thoracic General Hospital Of Athens Sotiria

location_facility: University of California at Davis Medical Center

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: IBPClin Instituto Brasil de Pesquisa Clinica

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo

location_facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli

location_facility: NorthShore University HealthSystem Clinical Trials Center

location_facility: Athens General Childrens Hospital Panagioti And Aglaia Kyriakou

location_facility: Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine

location_facility: Academic Alliance in Dermatology - Saint Petersburg Office

location_facility: Centro Internacional de Estudios Clinicos

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne

location_facility: National Allergy and Asthma Research, LLC


title: Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

acronym: DOMINICA

summary: A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to < 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and uncontrolled asthma receiving high-dose inhaled corticosteroid (ICS) plus at least one additional controller medication.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All requests will be evaluated as per the AZ disclosure commitment:

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

sponsor_collaborators: AstraZeneca Parexel

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
United States
Korea, Republic of
Spain
Taiwan
Canada
France


title: A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

summary: The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Switzerland
United States
India
Belgium
China
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
South Africa
Israel

location_facility: University of Iowa-Holden Comprehensive Cancer Center ( Site 0107)

location_facility: Universitätsklinikum Leipzig ( Site 0762)

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 1360)

location_facility: Tianjin Medical University Cancer Institute & Hospital-Biotherapy ( Site 1671)

location_facility: Ondokuz Mayıs Universitesi-Oncology department ( Site 1359)

location_facility: St. James's Hospital-Cancer clinical trials office ( Site 0900)

location_facility: Azienda Ospedaliero Universitaria Senese ( Site 1005)

location_facility: University College London Hospital ( Site 1405)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site

location_facility: Clinica Adventista Belgrano-Oncology ( Site 0211)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 1304)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0355)

location_facility: Cancercare Rondebosch Oncology-Clinical trials ( Site 1159)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0142)

location_facility: Sun Yat-sen University Cancer Center-melanoma ( Site 1655)

location_facility: Xinjiang Medical University Cancer Hospital - Urumqi-Bone and Soft Tissue Department ( Site 1674)

location_facility: Johannes Wesling Klinikum Minden-Skin Cancer Center Minden ( Site 0759)

location_facility: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1401)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1058)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1252)

location_facility: centre hospitalier lyon sud-Service de dermatologie ( Site 0714)

location_facility: Children's Hospital of Pittsburgh ( Site 0141)

location_facility: UCSF Medical Center at Mission Bay ( Site 0130)

location_facility: Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1501)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 0950)

location_facility: Hacettepe Universite Hastaneleri ( Site 1363)

location_facility: Universitaetsklinikum Essen-Klinik für Dermatologie, Venerologie und Allergologie ( Site 0761)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte-Hauttumorcentrum Charité (HTCC) ( Site 0756)

location_facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 1151)

location_facility: Universitätsklinikum St. Pölten-Department of Dermatology ( Site 0606)

location_facility: Medizinische Hochschule Hannover ( Site 0758)

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

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0653)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1004)

location_facility: Centro Avançado de Tratamento Oncológico- CENANTRON ( Site 0256)

location_facility: Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 1464)

location_facility: Jiangsu Province Hospital-Oncology Department ( Site 1663)

location_facility: UniversitätsSpital Zürich-Dermatology ( Site 1300)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1203)

location_facility: The Second Xiangya Hospital of Central South University-Oncology ( Site 1673)

location_facility: Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0204)

location_facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1455)

location_facility: Hopital Claude Huriez - CHU de Lille-Clinique de Dermatologie ( Site 0700)

location_facility: Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 0706)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0108)

location_facility: Royal Adelaide Hospital-RAH Cancer Centre ( Site 1457)

location_facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1054)

location_facility: Chongqing University Cancer Hospital ( Site 1651)

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

location_facility: Uniklinikum Salzburg-Department of Dermatology and Allergology ( Site 0604)

location_facility: Centre Hospitalier de Valence-Service de Dermatologie ( Site 0702)

location_facility: Universitätsmedizin Mannheim ( Site 0751)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1000)

location_facility: Medizinische Universität Wien-Department of Dermatology ( Site 0600)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 1664)

location_facility: California Pacific Medical Center - Pacific Campus ( Site 0111)

location_facility: Hospital General Universitario de Valencia ( Site 1200)

location_facility: Liv Hospital Ankara-Oncology ( Site 1353)

location_facility: New Zealand Clinical Research (Christchurch) ( Site 1509)

location_facility: A. C. Camargo Cancer Center ( Site 0258)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1056)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1205)

location_facility: Instituto Tumori Giovanni Paolo II ( Site 1003)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Dermatologie ( Site 0766)

location_facility: Clínica UC San Carlos de Apoquindo ( Site 0305)

location_facility: Seoul National University Hospital-Oncology ( Site 1600)

location_facility: Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0754)

location_facility: Georgetown University Medical Center ( Site 0144)

location_facility: Princess Margaret Cancer Centre ( Site 0006)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1602)

location_facility: All India Institute of Medical Sciences-Medical oncology ( Site 1552)

location_facility: Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 1306)

location_facility: The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0004)

location_facility: Gustave Roussy-Dermatologie ( Site 0713)

location_facility: GZA Ziekenhuizen campus Sint-Augustinus ( Site 0655)

location_facility: Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1355)

location_facility: Ankara City Hospital-Medical Oncology ( Site 1357)

location_facility: Bialostockie Centrum Onkologii ( Site 1065)

location_facility: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 1161)

location_facility: Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1307)

location_facility: Advocate Medical Group-Oncology ( Site 0102)

location_facility: Osaka International Cancer Institute ( Site 1754)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1204)

location_facility: Inova Schar Cancer Institute ( Site 0103)

location_facility: Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0113)

location_facility: Tata Memorial Hospital-Medical Oncology ( Site 1550)

location_facility: Fujian Provincial Cancer Hospital ( Site 1659)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 1451)

location_facility: Istituto Europeo di Oncologia IRCCS ( Site 1008)

location_facility: Universitaetsklinikum Erlangen-Hautklinik ( Site 0750)

location_facility: Medical Oncology Centre of Rosebank ( Site 1160)

location_facility: Fourth Hospital of Hebei Medical University ( Site 1669)

location_facility: Associação Hospitalar Beneficente São Vicente de Paulo-Instituto do Câncer ( Site 0259)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service de Dermatologie et Cancérologi

location_facility: Azienda Ospedaliero Universitaria ( Site 1002)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 1652)

location_facility: H.R.U Málaga - Hospital General-Oncology ( Site 1201)

location_facility: Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0601)

location_facility: UZ Leuven-General Medical Oncology ( Site 0650)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0955)

location_facility: The Melanoma & Skin Cancer Institute ( Site 0120)

location_facility: Instituto de Oncología de Rosario ( Site 0206)

location_facility: Hospital de Cancer de Londrina-Clinical Research Unit ( Site 0252)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1001)

location_facility: P3 Research - Palmerston North ( Site 1510)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0752)

location_facility: National Cancer Center Hospital ( Site 1750)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 0119)

location_facility: Universitaetsklinikum Heidelberg ( Site 0765)

location_facility: Sanford Fargo Medical Center ( Site 0127)

location_facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 0902)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Dermatologie ( Site 0602)

location_facility: The First Hospital of Jilin University-Oncology ( Site 1665)

location_facility: ANIMI - Unidade de Tratamento Oncologico ( Site 0255)

location_facility: A.O.U. Policlinico Paolo Giaccone-Depatment of Discipline Chirurgiche, Oncologiche e Stomatologiche

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1061)

location_facility: R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0132)

location_facility: Szpital Kliniczny im. H. Swiecickiego nr 2-Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej (

location_facility: West China Hospital, Sichuan University-Head and Neck Oncology ( Site 1667)

location_facility: Beijing Ji Shui Tan Hospital ( Site 1657)

location_facility: Cairns Hospital-Clinical Research Unit ( Site 1458)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 1668)

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0146)

location_facility: Melanoma Institute Australia-Clinical Trials Unit ( Site 1450)

location_facility: Rabin Medical Center-Oncology ( Site 0954)

location_facility: The Third Hospital of Zhengzhou-Oncology ( Site 1653)

location_facility: Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1361)

location_facility: Institut Català d'Oncologia - L'Hospitalet ( Site 1202)

location_facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1152)

location_facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

location_facility: Zachodniopomorskie Centrum Onkologii ( Site 1063)

location_facility: Emek Medical Center-oncology ( Site 0952)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1358)

location_facility: Calvary Mater Newcastle-Medical Oncology ( Site 1462)

location_facility: Medizinische Universitaet Innsbruck-Univ Klinik für Dermatologie, Venerologie und Allergologie ( Sit

location_facility: Northwestern Memorial Hospital ( Site 0109)

location_facility: AO Santa Maria della Misericordia ( Site 1006)

location_facility: Instituto Alexander Fleming-Alexander Fleming ( Site 0209)

location_facility: Mediservis del Tolima IPS S.A.S ( Site 0357)

location_facility: Fudan University Shanghai Cancer Center ( Site 1658)

location_facility: Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 1650)

location_facility: The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123)

location_facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0200)

location_facility: Ospedale Regionale Bellinzona e Valli ( Site 1308)

location_facility: Zhejiang Cancer Hospital-Oncology ( Site 1661)

location_facility: Niigata Cancer Center Hospital ( Site 1751)

location_facility: Länssjukhuset Ryhov-Onkologkliniken ( Site 1253)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1601)

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0110)

location_facility: Sunnybrook Research Institute ( Site 0003)

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia ( Site 0262)

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1064)

intervention_type: Biological


title: HERMES: Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

acronym: HERMES

summary: This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Thailand
Turkey
Croatia
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
North Macedonia
India
Romania
Belgium
China
Malaysia
Estonia
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel


acronym: INShore

summary: This open-label, randomized multicenter study is to assess the efficacy, safety, and pharmacokinetics (PK)/pharmacodynamics (PD) of obinutuzumab compared with mycophenolate mofetil (MMF) in children and young adults (aged >= 2-25 years) with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

location_facility: Lucile Packard Children's Hospital - Stanford

location_facility: National Center for Child Health and Development

location_facility: Hyogo prefectural Kobe Children's Hospital

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

location_facility: University of Utah - Primary Children's Hospital - PPDS

location_facility: UNC Hospitals Outpatient Center at Eastowne

location_facility: University of California Benioff Children's Hospital

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - Clinica De Marchi - INCIPIT - PIN

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

location_facility: CHU Montpellier- Hopital Arnaud de VIlleneuve

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Shiga University Of Medical Science Hospital

title: A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome

source: euctr

location_country:
Italy
Poland
Japan
Brazil
Belgium
United States
Spain
France


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa

summary: The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week extension period.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
United States
Spain
Bulgaria
Canada
France

location_facility:
Investigative Site US214
Investigative Site ES205
Investigative Site GB200
Investigative Site US220
Investigative Site AU203
Investigative Site US218
Investigative Site CA203
Investigative Site PL203
Investigative Site PL200
Investigative Site AU205
Investigative Site DE205
Investigative Site FR202
Investigative Site PL202
Investigative Site DE202
Investigative Site BG203
Investigative Site CA204
Investigative Site AU202
Investigative Site FR205
Investigative Site CA202
Investigative Site DE206
Investigative Site ES201
Investigative Site DK200
Investigative Site GB201
Investigative Site CA207
Investigative Site GB204
Investigative Site DE204
Investigative Site CA206
Investigative Site US204
Investigative Site DE208
Investigative Site DE203
Investigative Site US227
Investigative Site US233
Investigative Site GB202
Investigative Site IT202
Investigative Site CA205
Investigative Site US202
Investigative Site IT200
Investigative Site PL201
Investigative Site ES204
Investigative Site US212
Investigative Site IT203
Investigative Site ES202
Investigative Site US230
Investigative Site ES200
Investigative Site IT201
Investigative Site DE200
Investigative Site IT204
Investigative Site FR203
Investigative Site IT206
Investigative Site US209
Investigative Site GB203
Investigative Site BG201
Investigative Site US200
Investigative Site DK201
Investigative Site US215
Investigative Site FR201
Investigative Site AU204
Investigative Site FR206
Investigative Site AU201
Investigative Site IT207
Investigative Site US201
Investigative Site AU207
Investigative Site CA200
Investigative Site BG200
Investigative Site US205
Investigative Site US224
Investigative Site US223
Investigative Site US203
Investigative Site BG202
Investigative Site US217
Investigative Site US222
Investigative Site FR200
Investigative Site US229
Investigative Site US221
Investigative Site AU206
Investigative Site BG204
Investigative Site DE207
Investigative Site US208
Investigative Site US213
Investigative Site FR204
Investigative Site US206
Investigative Site US232
Investigative Site US226
Investigative Site ES203
Investigative Site US207
Investigative Site US228
Investigative Site US210
Investigative Site IT205
Investigative Site DE201
Investigative Site US225


title: A Randomized, Open-Label, Phase 2 Study of Botensilimab (AGEN1181) as Monotherapy and in Combination With Balstilimab (AGEN2034) or Investigator's Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer

summary: This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

status: Active, not recruiting

lead_sponsor: Agenus Inc.

location_country:
Italy
Brazil
Belgium
United States
Spain
Russian Federation
France

location_facility: Fondazione IRCCS Instituto Nazionale dei Tumori

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

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: "Clinical Hospital "RZD-Medicine" of Saint Petersburg"

location_facility: BHI of the Omsk region "Clinical oncological dispensary"

location_facility: Oregon Health & Science University (OHSU)

location_facility: ASST Grande Ospedale Metropolitano Niguarda

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

location_facility: Florida Cancer Specialists and Research Institute - Lake Mary

location_facility: RSBIHC "Altai Region Oncology Dispansery"

location_facility: FSAEI of HE I.M. Sechenov First Moscow State Medical University of the MoH of the RF

location_facility: CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)

location_facility: State Budgetary Healthcare Institution "Saint-Petersburg clinical scientific and practical center for specialised types of medical care (oncological)"

location_facility: Atlantic Health System - Morristown Medical Center

location_facility: Northwest Cancer Center Specialists - Vancouver Cancer Center - Compass Oncology Vancouver

location_facility: Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Petrov" оf the Ministry of Health of the Russian Federation

location_facility: Unversite Paris-Saclay Gustave Roussy Cancer Center Campus Paris

location_facility: SBIH of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Department of Health of the City of Moscow"

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Virginia Cancer Specialists/NEXT Virginia

location_facility: Vanderbilt University School of Medicine

location_facility: Hôpital Saint Antoine/AP-HP Hopital Saint Antoine (Pierre and Marie Curie University)

location_facility: Closed Joint Stock Company Medical Center "AVICENNA"

location_facility: Clínica Universidad de Navarra - Sede Madrid

location_facility: Branch office of " Hadassah Medical Ltd"

location_facility: Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho

location_facility: Clínica Universidad de Navarra - Sede Pamplona

location_facility: Earle A. Chiles Research Institute - Robert W. Franz Cancer Center - Providence Cancer Institute

location_facility: Instituto Sul Mineiro de Oncologia - ONCOMINAS

location_facility: "Kursk Oncological Research and Clinical Center named after G. E. Ostroverkhova"

location_facility: Service d'Oncologie Medicale - CHRU Besancon

location_facility: FSBI N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation

location_facility: SAHI "Orenburg Regional Clinical Oncological Dispensary"

location_facility: SBHI "Clinical Oncological Dispensary #1"

location_facility: Lifespan Clinical Research Center/Cancer Institute (Providence Rhode Island)

location_facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

location_facility: Keck School of Medicine of the University of Southern California

location_facility: Tennessee Oncology Nashville (Sarah Cannon)

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Santa Chiara

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia


title: A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

summary: This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

ipd_sharing_description:
Arcus 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.

For more information, please visit our website.

lead_sponsor: Arcus Biosciences, Inc.

sponsor_collaborators:
Arcus Biosciences, Inc.
Gilead Sciences

location_country:
Australia
Brazil
Japan
Thailand
Chile
Canada
Serbia
France
Lithuania
Portugal
Hungary
Hong Kong
United States
Romania
Malaysia
Philippines
Italy
Guatemala
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Georgia
Israel

location_facility: Centro Hospitalar e Universitário de Coimbra

location_facility: Kaiser Permanente - Los Angeles Medical Center

location_facility: Liga Contra o Câncer - Centro Avançado de Oncologia

location_facility: Dan L. Duncan Comprehensive Cancer Center at O'Quinn Medical Tower - Baylor St. Luke's Medical Center at McNair Campus

location_facility: Centre Armoricain de Radiothérapie, d?Imagerie Médicale et d?Oncologie

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Pontificia Universidad Catolica de Chile - Escuela De Medicina - Clinica UC San Carlos de Apoq

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: SCRI - Florida Cancer Specialists - Panhandle Research Office

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil

location_facility: Azienda Sanitaria Universitaria Friuli Centrale ? P.O. Santa Maria della Misericordia

location_facility: Vilniaus Universiteto Ligoninė Santariškių Klinikos

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: Bradford Hill Centro de Investigaciones Clinicas1

location_facility: General Oncology Hospital of Kifisias "Agioi Anargyroi"

location_facility: University of Texas Southwestern Medical Center

location_facility: Queen Mary Hospital (The University of Hong Kong)

location_facility: Providence Cancer Center Oncology and Hematology Care Westside Portland

location_facility: University Hospitals Cleveland Medical Center

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele

location_facility: Institute of Oncology and Radiology of Serbia (Institut za onkologiju i radiologiju Srbije)

location_facility: University Hospital Medical Center (KBC) Bezanijska Kosa

location_facility: SCRI - Florida Cancer Specialists - North Region Research Office

location_facility: Evex Hospitals - Kutaisi Referral Hospital

location_facility: Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Instituto Nacional de Cancerologia - Mexico

location_facility: SCRI - Tennessee Oncology - Nashville - Centennial

location_facility: Centro Hemato - Oncológico Privado (CHOP)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: USOR - Virginia Cancer Specialists - Fairfax Office

location_facility: Memorial Sloan Kettering Cancer Center - New York

location_facility: Humanity and Health Clinical Trial Centre

location_facility: SCRI - Florida Cancer Specialists - East Region Research Office

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor

location_facility: Clínica Universidad Católica del Maule - Talca

location_facility: University of California Irvine Health Chao Family Comprehensive Cancer Center

location_facility: Dr Pablo O. Torre Memorial Hospital - Riverside Medical Center

location_facility: Millennium Reasearch & Clinical Development'

location_facility: University of Louisville James Graham Brown Cancer Center

location_facility: Nebraska Cancer Specialists - Oncology Hematology West PC

location_facility: The Center for Cancer & Blood Disorders - Fort Worth

location_facility: Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

location_facility: ONCOSITE - Centro de Pesquisa Clinica Em Oncologia Ltda.

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: SCRI - Florida Cancer Specialists - South Region Research Office

location_facility: Centro Regional de Sub Especialidades Médicas (CRESEM) SA

location_facility: SCRI - Tennessee Oncology - Chattanooga - Memorial Plaza

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: Baguio General Hospital and Medical Center

location_facility: HealthPartners Cancer Center at Regions Hospital

location_facility: Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

location_facility: Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud

location_facility: University of Michigan Rogel Cancer Center

location_facility: Sunnybrook Health Sciences Centre - Bayview Campus

location_facility: Centro Especializado en Investigacion y Tratamiento Oncologicos SC

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Tisch Cancer Institute, Mount Sinai Hospital

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Queen Elizabeth II Health Sciences Centre-Victoria General


title: A Multicohort, Open Label, Phase 2 Study of Botensilimab (AGEN1181) for Treatment of Advanced Melanoma Refractory to Prior Checkpoint Inhibitor Therapy

summary: This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

location_country:
Germany
Italy
United Kingdom
Brazil
Switzerland
Belgium
United States
Spain
Russian Federation
France

location_facility: INCA II - Instituto Nacional de Cancer Jose Alencar Gomes da Silva

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Petrov National Medical Research Center of Oncology

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: Real e Benemerita Associaçao Portuguesa de Beneficencia - A Beneficencia Portuguesa de Sao Paulo

location_facility: Clinical Hospital Russian Railways - Medicine

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.

location_facility: Virginia K. Crosson Cancer Center at St. Jude Medical Center

location_facility: CHUV - Centre hospitalier universitaire vaudois

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Scottsdale Healthcare Hospitals DBA HonorHealth

location_facility: Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

location_facility: Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia


title: Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

lead_sponsor: Celcuity Inc

location_country:
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
Hungary
United States
India
Romania
Belgium
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Royal Marsden Hospital - London, Department of Medical Oncology

location_facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: Consultants In Medical Oncology and Hematology, P.C.

location_facility: Bacs-Kiskun County Hospital, Center for Oncoradiology

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Bon Secours St. Francis Medical Oncology Center

location_facility: University Hospital St. Poelten, Department of Internal Medicine I

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: Rosario's Oncology Institute and Medical Specialities (IOR)

location_facility: Prof. Dr. Alexandru Trestioreanu Institute of Oncology

location_facility: Local Healthcare Company of Monza (ASST Monza)

location_facility: Northwest Medical Specialties, PLLC - Tacoma

location_facility: American Oncology Partners of Maryland, PA

location_facility: Virginia Oncology Associates - Newport News

location_facility: Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)

location_facility: Caceres Hospital Complex - San Pedro de Alcantara General Hospital

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: University Hospital Complex of Santiago (CHUS), Department of Oncology

location_facility: University Hospitals Cleveland Medical Center

location_facility: Kaiser Permanente South Bay Medical Center

location_facility: University of California, Irvine Medical Center

location_facility: Thomayer University Hospital, Clinic of Oncology

location_facility: Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

location_facility: Christian Medical College, Department of Medical Oncology

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

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

location_facility: University of Debrecen Clinical Center, Institute of Oncology

location_facility: Cone Health Cancer Center at Alamance Regional, Hematology/Oncology

location_facility: ONCOSITE - Clinical Research Center in Oncology

location_facility: University Clinical Hospital Virgen de la Arrixaca, Department of Oncology

location_facility: University Hospital Graz, Department of Gynecology and Obstetrics

location_facility: LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy

location_facility: Hospital Hietzing, Department of Gynecology

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke

location_facility: Arizona Oncology (US Oncology/McKesson) - Goodyear

location_facility: Mater Hospital Brisbane, Mater Cancer Care Centre

location_facility: University Hospital Foundation Jimenez Diaz

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: University Hospital Olomouc, Clinic of Oncology

location_facility: New York Oncology Hematology, P.C. - Albany

location_facility: Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit

location_facility: The James Cancer Hospital and Solove Research Institute

location_facility: Maryland Oncology Hematology, P.A. - Rockville

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Specialists of North Florida - Jacksonville

location_facility: Torrance Memorial Physician Network - Cancer Care

location_facility: Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.

location_facility: Kaiser Permanente Medical Center - Vallejo

location_facility: Royal United Hospital, Department of Oncology/Hematology

location_facility: Salzburg Regional Hospital, Department of Internal Medicine III

location_facility: Northwest Cancer Specialists, PC - Tigard

location_facility: Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow

location_facility: University Hospital Bulovka, Institute of Radiation Oncology

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)

location_facility: Multiprofile Hospital for Active Treatment "Serdika", Sofia

location_facility: Hematology/Oncology Associates of Central New York

location_facility: University Hospital Johannes Gutenberg - University of Mainz

location_facility: Hollywood Private Hospital, Breast Cancer Research Centre

location_facility: Santa Maria della Misericordia University Hospital of Udine

location_facility: University Hospitals Leuven, Campus Gasthuisberg

location_facility: Polish Mother's Memorial Hospital-Research Institute

location_facility: St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre

location_facility: University Polyclinic Hospital of Modena

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Medical University Vienna, Department of Gynecology and Obstetrics

location_facility: University Hospital Motol, Clinic of Oncology

location_facility: South Broward Hospital District d/b/a Memorial Healthcare System

location_facility: Postgraduate Institute of Medical Education and Research (PGIMER)

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

location_facility: Administrative Society of Health Services, SC

location_facility: Prof. Dr. Ion Chiricuta Institute of Oncology

location_facility: European Institute of Oncology (IEO), IRCCS

location_facility: CHU La Timone - La Timone Children's Hospital

location_facility: Weill Cornell Medicine/New York-Presbyterian Hospital

location_facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics

location_facility: Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I

location_facility: Theageneio Anticancer Hospital of Thessaloniki

location_facility: Center for Medical Education and Clinical Research (CEMIC)

location_facility: Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic

location_facility: Illinois Cancer Specialists - Arlington Heights

location_facility: Catalan Institute of Oncology, Hospital Duran i Reynals

location_facility: Clinical Research Center Chapultepec Mexico City

location_facility: Maria Sklodowska-Curie - National Research Institute of Oncology

location_facility: Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)


type: Other Grant/Funding Number

title: A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

summary: The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Hong Kong
Denmark
Switzerland
United States
China
Italy
Austria
Korea, Republic of
Spain
Greece
Sweden

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Novant Health Presbyterian Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: Japan Community Healthcare Organization Kyushu Hospital

location_facility: Hematology-Oncology Associates of Central New York, PC

location_facility: Centre Hospitalier Universitaire d'Angers


title: Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

lead_sponsor: Revolution Medicines, Inc.

location_country:
Italy
Poland
Singapore
Australia
United States
Korea, Republic of
Spain
Thailand
Malaysia
Taiwan
Czechia
France

location_facility: Onkologicka klinika, Fakultni Nemocnice Olomouc

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Centro Ricerche Cliniche di Verona s.r.l.

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: University of Miami School of Medicine Sylvester Comprehensive Cancer Center

location_facility: Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove

location_facility: Austin Health, Olivia Newton-John Cancer Research & Wellness Centre

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center

location_facility: Columbia University Irving Medical Center

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: KontRASt-06: An Open-label Phase II Trial Evaluating the Activity and Safety of JDQ443 Single-agent as First-line Treatment for Patients With Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer With a PD-L1 Expression < 1% or a PD-L1 Expression ≥ 1% and an STK11 Co-mutation.

summary: This study aims to assess the antitumor activity and safety of JDQ443 single-agent as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor a KRAS G12C mutation and a PD-L1 expression < 1% regardless of STK11 mutation status (cohort A), or a PD-L1 expression ≥ 1% and an STK11 co-mutation (cohort B).

design_allocation: Non-Randomized

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Argentina
Brazil
Thailand
Turkey
France
Portugal
Hungary
United States
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Austria
Spain
Greece
Bulgaria

location_facility:
University of Toledo Precision Oncology
Novartis Investigative Site
The Brown University Oncology Group


title: A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

summary: This is a multicenter, randomized, open-label, controlled Phase 3 trial of XL092 + atezolizumab vs regorafenib in subjects with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed after or are intolerant to standard-of-care (SOC) therapy.

lead_sponsor: Exelixis

location_country:
Germany
Poland
Portugal
New Zealand
Hungary
Hong Kong
Singapore
Australia
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Thailand
Taiwan
France

location_facility:
Exelixis Clinical Site #96
Exelixis Clinical Site #113
Exelixis Clinical Site #29
Exelixis Clinical Site #21
Exelixis Clinical Site #101
Exelixis Clinical Site #16
Exelixis Clinical Site #1
Exelixis Clinical Site #69
Exelixis Clinical Site #80
Exelixis Clinical Site #39
Exelixis Clinical Site #12
Exelixis Clinical Site #35
Exelixis Clinical Site #60
Exelixis Clinical Site #25
Exelixis Clinical Site #94
Exelixis Clinical Site #53
Exelixis Clinical Site #103
Exelixis Clinical Site #64
Exelixis Clinical Site #92
Exelixis Clinical Site #72
Exelixis Clinical Site #108
Exelixis Clinical Site #56
Exelixis Clinical Site #99
Exelixis Clinical Site #115
Exelixis Clinical Site #4
Exelixis Clinical Site #89
Exelixis Clinical Site #30
Exelixis Clinical Site #27
Exelixis Clinical Site #86
Exelixis Clinical Site #2
Exelixis Clinical Site #84
Exelixis Clinical Site #34
Exelixis Clinical Site #38
Exelixis Clinical Site #26
Exelixis Clinical Site #106
Exelixis Clinical Site #100
Exelixis Clinical Site #8
Exelixis Clinical Site #62
Exelixis Clinical Site #78
Exelixis Clinical Site #74
Exelixis Clinical Site #13
Exelixis Clinical Site #45
Exelixis Clinical Site #32
Exelixis Clinical Site #55
Exelixis Clinical Site #10
Exelixis Clinical Site #36
Exelixis Clinical Site #98
Exelixis Clinical Site #105
Exelixis Clinical Site #37
Exelixis Clinical Site #77
Exelixis Clinical Site #90
Exelixis Clinical Site #33
Exelixis Clinical Site #66
Exelixis Clinical Site #24
Exelixis Clinical Site #65
Exelixis Clinical Site #52
Exelixis Clinical Site #7
Exelixis Clinical Site #110
Exelixis Clinical Site #51
Exelixis Clinical Site #102
Exelixis Clinical Site #40
Exelixis Clinical Site #114
Exelixis Clinical Site #104
Exelixis Clinical Site #3
Exelixis Clinical Site #83
Exelixis Clinical Site #112
Exelixis Clinical Site #107
Exelixis Clinical Site #19
Exelixis Clinical Site #87
Exelixis Clinical Site #70
Exelixis Clinical Site #88
Exelixis Clinical Site #18
Exelixis Clinical Site #14
Exelixis Clinical Site #68
Exelixis Clinical Site #41
Exelixis Clinical Site #44
Exelixis Clinical Site #22
Exelixis Clinical Site #57
Exelixis Clinical Site #23
Exelixis Clinical Site #15
Exelixis Clinical Site #91
Exelixis Clinical Site #82
Exelixis Clinical Site #6
Exelixis Clinical Site #97
Exelixis Clinical Site #31
Exelixis Clinical Site #76
Exelixis Clinical Site #20
Exelixis Clinical Site #46
Exelixis Clinical Site #47
Exelixis Clinical Site #111
Exelixis Clinical Site #11
Exelixis Clinical Site #54
Exelixis Clinical Site #109
Exelixis Clinical Site #17
Exelixis Clinical Site #81
Exelixis Clinical Site #58
Exelixis Clinical Site #28
Exelixis Clinical Site #43
Exelixis Clinical Site #48
Exelixis Clinical Site #63
Exelixis Clinical Site #95
Exelixis Clinical Site #42
Exelixis Clinical Site #85
Exelixis Clinical Site #73
Exelixis Clinical Site #49
Exelixis Clinical Site #59
Exelixis Clinical Site #79
Exelixis Clinical Site #75
Exelixis Clinical Site #9
Exelixis Clinical Site #450
Exelixis Clinical Site #67
Exelixis Clinical Site #71
Exelixis Clinical Site #5
Exelixis Clinical Site #61
Exelixis Clinical Site #93


title: A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

acronym: IRAKLIA

summary:
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms:

Arm SC: Isatuximab SC + Pd

Arm IV: Isatuximab IV + Pd

Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Hungary
United States
China
Italy
Norway
United Kingdom
Spain
Greece
Taiwan
Sweden

location_facility: Texas Oncology - San Antonio Site Number : 8400020

location_facility: Clínica São Germano Site Number : 0760001

location_facility: Hospital Mae de Deus Site Number : 0760003

location_facility: Arizona Oncology Associates, PC - HAL Site Number : 8400015

location_facility: UW Cancer Center at ProHealth Care Site Number : 8400001

location_facility: Atlantic Health System Site Number : 8400005

location_facility: Instituto COI de Educacao e Pesquisa Site Number : 0760004

location_facility: Novant Health Forsyth Medical Center Site Number : 8400114

location_facility: Texas Oncology Baylor Sammons Site Number : 8400022

location_facility: A Beneficencia Portuguesa de Sao Paulo - Hospital Beneficencia Portuguesa - BP Mirante Site Number : 0760002

location_facility: Rocky Mountain Cancer Centers, LLP Site Number : 8400021

location_facility: Oncology_Hematology Care Clinical Trials, LLC Site Number : 8400016

location_facility: George E. Wahlen Salt Lake City VA Medical Center Site Number : 8400011

location_facility: Oncology Associates Of Oregon, P.C. Site Number : 8400018

location_facility: Comprehensive Cancer Centers of Nevada Site Number : 8400019

location_facility: Gibbs Cancer Center-Spartanburg Medical Center Site Number : 8400002

location_facility: New York Oncology Hematology, P.C. Site Number : 8400017

location_facility: Hattiesburg Clinic Site Number : 8400006


title: A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma

summary: The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Italy
Poland
United Kingdom
Australia
United States
Spain
France

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Barbara Ann Karmanos Cancer Institute Site#159

location_facility: NYU Langone Laura and Isaac Perlmutter Cancer Center Site #153

location_facility: Ośrodek Badań Klinicznych Wczesnych Faz - Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia Site#650

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Rochester Skin Lymphoma Medical Group, PLLC Site #147

location_facility: University of Michigan Rogel Cancer Center

location_facility: University of Colorado Anschutz Medical Campus Site #118

location_facility: Hospital Universitario 12 de Octubre Site#710

location_facility: Fondazione IRCCS San Gerardo dei Tintori Site #655

location_facility: Hospital Universitario Marqués de Valdecilla Site#711

location_facility: U.O.C. di Ematologia Pad. 8IRCCS Azienda OspedalieroUniversitaria di Bologna Site#651

location_facility: The University of Texas MD Anderson Cancer Center Site #101

location_facility: Hospital Universitario Fundación Jiménez Díaz Site #703

location_facility: Centre de Lutte contre le Cancer - Centre Antoine Lacassagne Site#562


title: Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)

summary:
The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.

The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Finland
Germany
Italy
Portugal
Israel
United Kingdom
Sweden
Netherlands
Austria
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Universitair Medisch Centrum Groningen - Department of Medical Oncology

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: I.F.O. Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: The Ohio State University Wexner Medical Center

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Hospidal Universitario Ntra. Sra. De Valme

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

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

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC)

location_facility: Institut Universitari Dexeus-Quiron - Servei d oncologia medica - Institut Oncologic Dr. Rosell

location_facility: Rabin Medical Center Oncology Beilinson Campus


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy, Safety, Tolerability, PK, and Biomarker Effects of PTC857 in Adult Subjects With Amyotrophic Lateral Sclerosis (CARDINALS)

acronym: CARDINALS

summary: This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.

lead_sponsor: PTC Therapeutics

location_country:
Germany
Italy
Poland
Argentina
Australia
Japan
Netherlands
Sweden
Belgium
United States
Spain
Czechia
France

location_facility: Universitaetsklinikum Schleswig-Holstein (UKSH) Campus Luebeck, Klinik fuer Neurologie, Praezisionsneurologie

location_facility: University hospital Brno, Department of Neurology

location_facility: Lewis Katz School of Medicine at Temple Universtiy

location_facility: UC Irvine Health ALS and Neuromuscular Center

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Holy Cross Hospital, Phil Smith Neuroscience Institute

location_facility: Norrlands universitetssjukhus Neurologens Forskningsavdelning

location_facility: Istituti Clinici Scientifici Maugeri IRCCS

location_facility: Henry Ford Health System Department of Neurology

location_facility: Neurology Associates, P.C. / Somnos Clinical Research

location_facility: Maggiore della Carita University Hospital, Neurology department, ALS center

location_facility: IRCCS Fondazione Mondino - Reparto Neuroncologia/Neuroinfiammazione

location_facility: CHU Gui de Chauliac (Pharmacie Saint-Eloi & Gui de Chauliac, Hopital Saint-Eloi)

location_facility: National Neuromuscular Research Institute

location_facility: ALS Clinical Research Center, University Hospital Policlinico "P Giaccone"

location_facility: Skanes universitetssjukhus, VE Neurologi

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Forbes Norris MDA/ALS Research Center at California Pacific Medical Center

location_facility: University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare

location_facility: Unidad Neuromuscular. Servicio de Neurologia Hospital Universitari Vall d'Hebron

location_facility: National Hospital Organization Matsumoto Medical Center, Neurology department

location_facility: University of Kansas Medical Center (KUMC) - Landon Center on Aging


title: A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma

summary: The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

location_country:
Germany
Italy
Poland
Hong Kong
Singapore
Australia
Japan
United States
China
Korea, Republic of
Spain
Taiwan
Canada
Puerto Rico
France

location_facility: Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

location_facility: Medical College of Wisconsin/ Froedtert Hospital

location_facility: California Pacific Hematology Oncology Associates

location_facility: Harvard Medical School - Massachusetts General Hospital MGH - Cancer Center

location_facility: Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center

location_facility: Albert Einstein School of Medicine Montefiore

location_facility: Pan American Center for Oncology Trials, LLC


title: A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixed-dose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants With Later-lines of Metastatic Colorectal Cancer

summary: The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

location_country:
Germany
Poland
Argentina
Australia
Japan
Chile
Czechia
Canada
France
Switzerland
United States
Belgium
China
Puerto Rico
Italy
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

location_facility: University of Michigan - Rogel Cancer Center

location_facility: University of Wisconsin-Madison - Wisconsin Institutes for Medical Research (WIMR)

location_facility: Perelman School of Medicine at the University of Pennsylvania

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Virginia Commonwealth University Massey Cancer Center

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


title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

acronym: Prevent

summary: This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.

ReferenceCitation: Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.

lead_sponsor: AlloVir

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Alabama at Birmingham Children's of Alabama

location_facility: Institut Jules Bordet and the Childrens Hospital

location_facility: Cellular Therapy Program - CHU Sainte-Justine (McGill)

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Fondazione I.R.C.C.S. Policlinico San Matteo

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Inonu University Turgut Özal Medical Centre

location_facility: Hospital Regional Universitario de Malaga

location_facility: Queen Elizabeth University Hospital - Glasgow

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: University Hospital Gasthuisberg and Leuven

location_facility: University of Sacred Heart Policlinico A. Gemelli

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Indiana University Hospital Simon Comprehensive Cancer Center

location_facility: University of Florida (UF) - Gainesville

location_facility: University of Utah/Primary Childrens Hospital

location_facility: Gazi University Medical Faculty Hospital

location_facility: University Hospitals Bristol - Bristol Hospital for Children

location_facility: University of California, Los Angeles (UCLA)

location_facility: Great Ormond Street Hospital for Children

location_facility: UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center

location_facility: Leukemia/ BMT Program of British Columbia - Vancouver General Hospital

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (AOUI)

location_facility: University of California San Francisco - Benioff Children's Hospital

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Ankara Onkoloji Egitim Ve Arastirma Hastanesi

location_facility: Stony Brook University Hospital Cancer Center

location_facility: The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination With Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

summary: This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids

lead_sponsor: Equillium

sponsor_collaborators:
Equillium
Biocon Limited

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

location_facility: Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Sarah Cannon Research Institute, LLC (SCRI)

location_facility: John Theurer Cancer Center At Hackensack UMC

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Martin Luther Universitat Halle-Wittenberg

location_facility: AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie

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

location_facility: McGill University Health Center - Research Institute

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

location_facility: The University of Chicago Medical Center (UCMC)

location_facility: Oregon Health & Science University (OHSU)

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: University of California, Los Angeles (UCLA) - Medical Center