title: A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

summary: The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts).

location_country:
Taiwan
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
China
Malaysia
Belgium
Puerto Rico
Germany

location_facility: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

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

location_facility: University of California, Los Angeles UCLA

location_facility: Cancer & Hematology Centers of Western Michigan, PC

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: University of Maryland School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Pan American Center for Oncology Trials LLC

location_facility: The Second Hospital To Dalian Medical University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center

location_facility: Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Centre Hospitalier Regional Universitaire Besancon

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: No.1 Affiliated Hospital, Medical College of Zhejiang University

location_facility: Centre Jean Bernard - Clinique Victor Hugo

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

location_facility: Massachusetts General Hospital Cancer Center

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: University of Alabama at Birmingham - The Kirklin Clinic

location_facility: Sichuan University West China Hospital Cancer Center


type: EudraCT Number

type: Other Identifier

title: A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination With Nivolumab 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).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Johns Hopkins Medicine - Sidney Kimmel Comprehensive Cancer Center

location_facility: Medical College of Wisconsin/ Froedtert Hospital

location_facility: Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

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

location_facility: California Pacific Hematology Oncology Associates

location_facility: Albert Einstein School of Medicine Montefiore

location_facility: Pan American Center for Oncology Trials, LLC

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2 Trial to Evaluate the Safety and Efficacy of Domvanalimab (AB154) and Zimberelimab (AB122) -Based Treatment Combinations in Patients With Advanced Upper Gastrointestinal Tract Malignancies

acronym: EDGE-Gastric

summary: This study will evaluate the safety and efficacy of the anti-T cell immunoglobulin and ITIM domain (TIGIT) monoclonal antibody domvanalimab, the anti-programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy in the first-line setting, and of domvanalimab and zimberelimab in the second-line or greater setting in participants with locally advanced unresectable or metastatic esophageal, gastroesophageal junction (GEJ), and gastric adenocarcinoma.

design_allocation: Non-Randomized

ipd_sharing: Yes

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.

lead_sponsor: Arcus Biosciences, Inc.

location_country:
Korea, Republic of
United States
France

location_facility: Chonnam National University Hwasun Hospital

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

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

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

location_facility: New York-Presbyterian Columbia University Medical Center

location_facility: Greenville Health System Cancer Institute (Prisma)

location_facility: Virginia Cancer Specialists-Fairfax Office

location_facility: Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers

location_facility: Institut de Recherche en Cancerologie de Montpellier

location_facility: Kyungpook National University Chilgok Hospital

intervention_type: Drug


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

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

location_facility: Fort Wayne Medical Oncology & Hematology

location_facility: Eastern Connecticut Hematology And Oncology Associates

location_facility: Chattanooga Oncology & Hematology Associates, Pc

location_facility: The Center For Cancer And Blood Disorders

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

location_facility: VA Commonwealth University - Massey Cancer Center

location_facility: Charleston Hematology Oncology Associates CHOA


title: Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

summary: The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Argentina
Mexico
Slovakia
Brazil
Canada
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Colombia

location_facility: Tong Ren Hospital Shanghai Jiao Tong University school of medicine

location_facility: JA Hokkaido Koseiren Obihiro Kosei Hospital

location_facility: Advocate Health - Aurora St. Luke's Medical Center

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital of the University of Pennsylvania

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

location_facility: National Center of Neurology and Psychiatry

location_facility: Klinikum rechts der Isar - der Technischen Universität München

location_facility: Fujian Medical University Union Hospital

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Tokyo Women's Medical University Hospital

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Neurologicka ambulancia MUDr.Dupejova s.r.o.

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Qianfoshan hospital of Shandong Province

location_facility: Hospital Universitario Antonio Pedro - Universidades Federal Fluminense

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: St. Josef-Hospital, Ruhr-Universität Bochum

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Seconda Università degli Studi di Napoli, Neurologica

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Forbes Norris MDA/ALS Research and Treatment Center

location_facility: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

location_facility: South Shore Neurologic Associates - Patchogue

location_facility: Xiangya Hospital Central South University

location_facility: Xuanwu Hospital, Capital Medical University

location_facility: Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca


title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 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, formerly 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

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.

ipd_sharing: No

lead_sponsor: AlloVir

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

location_facility: Great Ormond Street Hospital for Children

location_facility: Washington University School of Medicine

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

location_facility: Inonu University Turgut Özal Medical Centre

location_facility: University of Sacred Heart Policlinico A. Gemelli

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University of California, San Francisco Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Stony Brook University Hospital Cancer Center

location_facility: Weil Medical College - NY Presbyterian Hospital

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

location_facility: University of Florida - Division of Hematology & Oncology

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

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Institut Claudius Regaud Cancer Comprehensive Center - IUCT Oncopole

location_facility: Unidad De Hemofilia, Hospital Regional Universitario De Malaga

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

location_facility: Leukemia/BMT Program of British Columbia

location_facility: Gazi University Medical Faculty Hospital

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Cheonam National University Hwasun Hospital

location_facility: Institut Jules Bordet and the Childrens Hospital

location_facility: University Hospital Gasthuisberg and Leuven

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

intervention_type: Biological


title: A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)

summary: A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

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

lead_sponsor: AstraZeneca

location_country:
Taiwan
Brazil
Portugal
Spain
Italy
Russian Federation
Mexico
Canada
Thailand
Vietnam
Philippines
Korea, Republic of
United States
France
China
India
Belgium
Japan
Germany
Malaysia

intervention_type: Procedure


title: A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

summary:
This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.

The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Canada
France
Germany

location_facility:
LEO Pharma Investigational Site
LEO Pharma investigational site


title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2

acronym: COMBINE 2

summary:
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes.

The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide.

Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries.

Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach.

The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls.

At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Taiwan
Brazil
Greece
Russian Federation
Canada
Switzerland
Hungary
United States
France
China
Israel
Japan
Sweden
Slovakia


type: Registry Identifier

title: A Randomized, Double-Blind, Phase 3 Study of MK-7684A Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants With Metastatic Non-Small Cell Lung Cancer

summary: The primary hypotheses are that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Taiwan
Brazil
Spain
United Kingdom
Austria
Mexico
Argentina
Korea, Republic of
United States
Chile
China
France
Colombia
Israel
Germany
Turkey
Japan

location_facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1506)

location_facility: Hospital Clinico San Carlos-Oncology Department ( Site 1107)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0206)

location_facility: UCHealth Memorial Hospital-Heme Onc ( Site 0003)

location_facility: Sourasky Medical Center-Oncology ( Site 1305)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0202)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2254)

location_facility: Hospital Provincial del Centenario ( Site 0212)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0606)

location_facility: Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 0902)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 1306)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1907)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2607)

location_facility: Hospital Insular de Gran Canaria-Oncology ( Site 1102)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 2413)

location_facility: Okayama University Hospital ( Site 2410)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1903)

location_facility: Clínica de Oncologia Reichow ( Site 0407)

location_facility: Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0913

location_facility: University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)

location_facility: Saitama Prefectural Cancer Center ( Site 2406)

location_facility: Liv Hospital Ankara-Oncology ( Site 1205)

location_facility: Oncomedica S.A.-Oncomedica S.A ( Site 0609)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2251)

location_facility: Kepler Universitätsklinikum ( Site 0707)

location_facility: Centre Hospitalier d'Avignon ( Site 0810)

location_facility: Kansai Medical University Hospital ( Site 2415)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0204)

location_facility: Trakya University-Medical Oncology ( Site 1203)

location_facility: Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)

location_facility: Meir Medical Center-oncology ( Site 1301)

location_facility: Umraniye Training and Research Hospital-medical oncology ( Site 1206)

location_facility: Chungnam national university hospital-Department of Internal Medicine ( Site 2203)

location_facility: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 2625)

location_facility: Cancer and Hematology Centers of Western Michigan ( Site 0002)

location_facility: Hospital Clínico Universitario Lozano Blesa-Oncology ( Site 1105)

location_facility: Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1906)

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hôpital-Service de pneumologie et oncologie th

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1209)

location_facility: UKGM Gießen/Marburg-Medical Clinic V ( Site 0912)

location_facility: Medizinische Universität Graz ( Site 0704)

location_facility: Kanagawa cancer center-Department of Thoracic Oncology ( Site 2405)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)

location_facility: Korea University Guro Hospital-Internal Medicine ( Site 2204)

location_facility: Institut de Cancérologie de l'Ouest ( Site 0802)

location_facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2621)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2252)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0705)

location_facility: Acibadem Altunizade Hospital-Oncology ( Site 1207)

location_facility: Hospital Civil Fray Antonio Alcalde ( Site 0307)

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0405)

location_facility: GEFOS Gesellschaft f. onkologische Studien ( Site 0909)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2618)

location_facility: University College London Hospital-Cancer Clinical Trials Unit ( Site 1509)

location_facility: The First Affiliated hospital of Xiamen University ( Site 2626)

location_facility: Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2202)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1904)

location_facility: Japanese Foundation for Cancer Research ( Site 2402)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1202)

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0203)

location_facility: Medizinische Universitaet Innsbruck ( Site 0703)

location_facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2201)

location_facility: Centrum Medyczne Ostrobramska NZOZ Magodent ( Site 1908)

location_facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)

location_facility: Stony Brook University-Cancer Center ( Site 0013)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2414)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0403)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0209)

location_facility: Administradora Country S.A. - Clinica del Country ( Site 0601)

location_facility: CENTRE HOSPITALIER REGIONAL D'ORLEANS-Service de Pneumologie ( Site 0806)

location_facility: Rambam Health Care Campus-Oncology ( Site 1303)

location_facility: Shanghai Pulmonary Hospital-Oncology Department ( Site 2601)

location_facility: New England Cancer Specialists ( Site 0008)

location_facility: CENTRO DE INFUSION E INVESTIGACION ONCOLOGIA DE SALTILLO S.C. ( Site 0304)

location_facility: Zhejiang Cancer Hospital-Oncology ( Site 2612)

location_facility: Centro de Investigación Oncológica del Norte ( Site 0504)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0502)

location_facility: University of Virginia Cancer Center ( Site 0018)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1302)

location_facility: Nippon Medical School Hospital ( Site 2404)

location_facility: CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 1106)

location_facility: China Medical University Hospital ( Site 2253)

location_facility: Centro de Oncología de Precisión ( Site 0515)

location_facility: The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site

location_facility: Centre Hospitalier d'Annecy ( Site 0807)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

location_facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2624)

location_facility: Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1103)

location_facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

location_facility: Hyogo Cancer Center-Thoracic Oncology ( Site 2409)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1208)

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust-Research and Development ( Site 1501)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0406)


title: Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma

summary:
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.

The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.

During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment.

Participants can continue treatment in the study as long as they benefit from it and can tolerate it.

Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing_description:
Once the time frame criteria given under number 4 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 outlined in the website.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Hong Kong
Portugal
Australia
Turkey
Norway
Sweden
Canada
China
Germany
Denmark
Taiwan
Greece
Ireland
Finland
France
Netherlands

location_facility: FONK, Early Phase Oncology Research Unit

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: BC Cancer Agency Vancouver Cancer Centre

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

location_facility: Princess Alexandra Hospital Division of Cancer Service

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Leids Universitair Medisch Centrum Klinische Oncologie

location_facility: Institut Universitaire du Cancer Toulouse

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Policlinico Universitario Campus Bio-Medico Oncologia Medica

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Virgen de la Victoria


acronym: FIONA

title: A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria

lead_sponsor: Bayer

source: euctr

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

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

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Israel
Turkey
Sweden
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: Health Corporation of Galilee Medical Center

location_facility: Great Ormond Street Hospital for Children

location_facility: CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

location_facility: Rigshospitalet, Dept Pediatrics & Adelescent Med.

location_facility: H Univ. Virgen Rocío | Unidad Nefrología Pediátrica

location_facility: Oregon Health and Science Univ | Doernbecher Childrens Hosp

location_facility: Children's Hospital of Athens P&A Kyriakou

location_facility: Wilf Children's Hospital Shaare Zedek Medical Center

location_facility: Pusan National University Yangsan Hospital

location_facility: Baskent Universitesi Tip Fakultesi Hastanesi

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali

location_facility: Universitätsklinikum Hamburg Eppendorf (UKE)

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Pediatric Early Phase Trial Unit, Tampere University Hospita

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)

location_facility: Children's hospital Affiliate of Vilnius University Hospital

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Hôpital Arnaud de Villeneuve - Montpellier

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Univ of Texas Health Science Center | Nephrology Res Dept

location_facility: Alberta Children's Hospital, University of Calgary

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

location_facility: Cincinnati Children's Hospital and Medical Center

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Hippokration General Hospital of Thessaloniki

location_facility: Seoul National University Bundang Hospital

location_facility: The Hospital for Sick Children (SickKids)

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie

location_facility: University General Hospital of Heraklion

location_facility: Clalit Health Services Schneider Children's Medical Center

location_facility: Medizinische Univ Graz | Kinder & Jugendheilkunde

summary:
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.

The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.

The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.

So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.

The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.

To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests.

This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:

either finerenone or the placebo, in addition to
either ACEI or ARB, whichever they take as part of their normal treatment

Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will:

have their blood pressure, heart rate, temperature, height and weight measured
have blood and urine samples taken
have physical examinations
have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)
answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer
answer questions about how they are feeling, or have their parents or guardians answer
answer question about how they like the study medication, or have their parents or guardians answer

The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

The doctors will check the participants' health about 30 days after the participants take their last treatment.


title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

summary: The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

location_country:
United Kingdom
Italy
United States
Belgium
Japan
Poland
Russian Federation
Australia
Israel
Turkey
Mexico
Norway
Brazil
Canada
China
Germany
Denmark
Ireland
New Zealand
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0027)

location_facility: Shandong Cancer Hospital-Oncology Department ( Site 0733)

location_facility: SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)

location_facility: Novant Health Forsyth Medical Center ( Site 0057)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 0720)

location_facility: Ninewells Hospital and Medical School ( Site 2826)

location_facility: Instituto de Radiomedicina-hemato-oncologia ( Site 0604)

location_facility: Wuhan Union Hospital-Medical Oncology ( Site 0735)

location_facility: Aalborg Universitetshospital, Syd ( Site 0901)

location_facility: Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)

location_facility: Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)

location_facility: Iwate Medical University Hospital ( Site 1613)

location_facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma

location_facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)

location_facility: Moscow City Oncology Hospital #62 ( Site 2214)

location_facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)

location_facility: Charité Campus Virchow-Klinikum ( Site 1201)

location_facility: Aichi Cancer Center Hospital ( Site 1610)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 2818)

location_facility: Fujian Provincial Cancer Hospital ( Site 0713)

location_facility: MetroHealth Medical Center-Cancer Care Center ( Site 0047)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)

location_facility: Texas Oncology - The Woodlands_Lee ( Site 0043)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 1603)

location_facility: Westmorland General Hospital ( Site 2815)

location_facility: Clínica Universitaria Colombia ( Site 0806)

location_facility: Roswell Park Cancer Institute ( Site 0039)

location_facility: Ege University Medicine of Faculty ( Site 2702)

location_facility: Japanese Foundation for Cancer Research ( Site 1605)

location_facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1803)

location_facility: St. James's Hospital-Cancer clinical trials office ( Site 2821)

location_facility: National Cancer Center Hospital ( Site 1612)

location_facility: Advocate Medical Group-Oncology ( Site 0049)

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)

location_facility: Hokkaido University Hospital ( Site 1604)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog

location_facility: Istanbul Universitesi Cerrahpasa ( Site 2709)

location_facility: Zhongda Hospital Southeast University ( Site 0723)

location_facility: iCan Oncology Center Centro Medico AVE ( Site 1704)

location_facility: St. John of God Subiaco Hospital ( Site 0203)

location_facility: Lanzhou university second hospital ( Site 0734)

location_facility: Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

location_facility: Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)

location_facility: The Royal Cornwall Hospital ( Site 2804)

location_facility: University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 1705)

location_facility: Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)

location_facility: West China Second University Hospital Sichuan University ( Site 0740)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)

location_facility: Saitama Medical University International Medical Center ( Site 1601)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)

location_facility: Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)

location_facility: Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)

location_facility: Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)

location_facility: Providence Portland Medical Center ( Site 0048)

location_facility: Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)

location_facility: Emek Medical Center-Gyn-Onc ( Site 1406)

location_facility: St. Vincent Hospital and Health Care Center, Inc ( Site 0032)

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)

location_facility: McGill University Health Centre ( Site 0502)

location_facility: Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)

location_facility: University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054

location_facility: Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)

location_facility: Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)

location_facility: The First Hospital of Jilin University ( Site 0710)

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)

location_facility: Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)

location_facility: Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)

location_facility: Centre de Cancérologie du Grand Montpellier ( Site 2908)

location_facility: Inova Schar Cancer Institute ( Site 0019)

location_facility: Columbia University Medical Center ( Site 0010)

location_facility: Institut Curie - site Saint-Cloud ( Site 2909)

location_facility: Institut Jules Bordet-Medicine Oncology ( Site 0302)

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 0808)

location_facility: Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)

location_facility: AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)

location_facility: Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)

location_facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)

location_facility: ANIMI - Unidade de Tratamento Oncologico ( Site 0408)

location_facility: Clínica Vespucio-Hemato - Ocology ( Site 0607)

location_facility: National Cancer Center Hospital East ( Site 1609)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)

location_facility: Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)

location_facility: The West Clinic, PLLC dba West Cancer Center ( Site 0058)

location_facility: Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)

location_facility: Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0602)

location_facility: Ankara University Hospital Cebeci ( Site 2701)

location_facility: Xiangya Hospital Central South University-Gynecology ( Site 0705)

location_facility: Centre François Baclesse-Recherche clinique ( Site 2904)

location_facility: Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)

location_facility: Osaka International Cancer Institute ( Site 1602)

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)

location_facility: University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)

location_facility: The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)

location_facility: Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)

location_facility: Shaare Zedek Medical Center ( Site 1405)

location_facility: Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)

location_facility: WK Physicians Network / Hematology Oncology Associates ( Site 0034)

location_facility: Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)

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

location_facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2803)

location_facility: CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)

location_facility: Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)

location_facility: Ogarev Mordovia State University ( Site 2209)

location_facility: Seoul National University Hospital ( Site 2302)

location_facility: Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)

location_facility: IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)

location_facility: Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)

location_facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)

location_facility: Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi

location_facility: Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)

location_facility: Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)

location_facility: Novant Health Presbyterian Medical Center ( Site 0029)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 2707)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit

location_facility: Aultman Hospital-Oncology Clinical Trials ( Site 0009)


title: A Multi-centre Prospective Non-interventional Clinical Investigation Studying the Glycaemic Control in Patients With Type 1 Diabetes When Introducing a NovoPen® 6 for Treatment With Tresiba® (Insulin Degludec) & Fiasp® (Fast-acting Insulin Aspart) in a Real-world Setting

acronym: CONNECT 1

summary:
The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® & Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels.

Participants will use Tresiba® & Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor.

NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken.

NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application.

Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study.

The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

location_country: Denmark Sweden France Belgium

status_simplified: Unknown


title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

acronym: CONnECT

summary: This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.

lead_sponsor: Diurnal Limited

location_country:
Japan
United States
France

location_facility: Diurnal Investigational Site in Yokohama-shi

location_facility: Diurnal Investigational Site in Izumi-shi

location_facility: Diurnal Investigational Site in Shinjuku-ku

location_facility: Diurnal Investigational Site in Maryland

location_facility: Diurnal Investigational Site in Rochester

location_facility: Diurnal Investigational Site in Michigan

location_facility: Diurnal Investigational Site in Toulouse

location_facility: Diurnal Investigational Site in Jacksonville

location_facility: Diurnal Investigational Site in Setagaya-Ku

location_facility: Diurnal Investigational Site in Fuchu-Shi


title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Head and Neck Squamous Cell Carcinoma (HNSCC)

summary:
The is a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Substudy 1-Cohort A1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who are treatment-naïve for recurrent and/or metastatic (R/M) disease.

Substudy 4-Cohort B1 aims to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen.

Substudy 5-Cohort B2 aims to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen & cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.

status: Active, not recruiting

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:
Poland
Taiwan
Spain
Italy
Netherlands
Argentina
Canada
Korea, Republic of
United States
Chile
France
Germany

location_facility: Thomas Jefferson University Hospital-Site Number:8400003

location_facility: University of Colorado-Site Number:8400004

location_facility: Seattle Cancer Care Alliance-Site Number:8400006

location_facility: University of Michigan-Site Number:8400008


title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment

summary:
The main aim of this study is to:

evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of Tarlatamab for Part 1 only
evaluate anti-tumor activity of Tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2

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

lead_sponsor: Amgen

location_country:
Denmark
Poland
Taiwan
Portugal
Spain
Greece
Austria
Italy
Netherlands
United Kingdom
Switzerland
Korea, Republic of
United States
France
Singapore
Belgium
Japan
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital Regional Universitario de Malaga

location_facility: Instituto Catalan de Oncologia Hospital Duran i Reynals

location_facility: General Hospital of Patras Agios Andreas

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

location_facility: Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: University of Pittsburgh Medical Center Cancer Pavillion

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Yonsei University Health System Severance Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Grand Hopital de Charleroi - Site Saint Joseph

location_facility: Wake Forest Baptist Comprehensive Cancer Research Center

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: West Virginia University Health Sciences Center

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Seoul National University Bundang Hospital


title: A Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

summary: This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

lead_sponsor: European Myeloma Network

location_country:
Spain
Italy
Greece
Netherlands
United States
France
Germany

location_facility: Reading Hospital - McGlinn Cancer Institute

location_facility: Institut Catala D Oncolocia Hospitalet - Hospital Duran i Reynals

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS)

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: A.O.U. Policlinico S. Martino - Ematologia

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona

location_facility: CHU Poitiers - Pôle régional de Cancérologie

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

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: General Hospital of Athens"Evangelismos"

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: The Oncology Institute of Hope and Innovation

location_facility: H. General Universitario Morales Meseguer

location_facility: ASST Spedali Civili di Brescia - Ematologia

location_facility: Azienda Ospedaliera Universitaria di Udine

location_facility: Medical University of South Carolina. Hollings Cancer Center


title: A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Spain
Italy
Latvia
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Japan
Germany
Slovakia
Czechia


title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

summary:
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.

Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

location_country:
Poland
Slovenia
Italy
Thailand
Hungary
United States
France
India
Malaysia
South Africa
Japan
Germany
Turkey
Czechia


title: A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

summary: The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

ipd_sharing_description:
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

location_country:
Poland
Spain
Italy
Australia
Argentina
Hungary
United States
Chile
France
Israel
Belgium
Turkey
Germany

location_facility: Mid Florida Hematology and Oncology Center


title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Portugal
Austria
Australia
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Greece
Finland
France
Chile

location_facility: University of Iowa-Holden Comprehensive Cancer Center

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

location_facility: Levine Cancer Institute-Cutaneous Malignancies/Immunotherapy

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie

location_facility: Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma

location_facility: The Angeles Clinic And Research Institute.

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Atlantic Health System Morristown Medical Center

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

location_facility: Winship Cancer Institute of Emory University

location_facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica

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

location_facility: NYU Langone Health-Perlmutter Cancer Center

location_facility: University of Texas MD Anderson Cancer Center-Melanoma Medical Oncology

location_facility: Highlands Oncology Group-Research Department

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica del Melanoma, Sarcoma e Tumori Rar

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Georgetown University Medical Center Lombardi Cancer Center

summary: The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.


title: A Descriptive, Prospective, Multi-country, Multicentre Study to Assess Performance of Genital Herpes Simplex Virus-2 (HSV-2) Related Disease Endpoints Based on Patient-reported Health Outcomes, Self-swabbing Collected Via Decentralised Approach in Patients ≥ 18 Years of Age in the United States and Europe.

summary:
The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe.

More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Finland
United States
France


acronym: COURAGE-ALS

title: A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

lead_sponsor: Cytokinetics

location_country:
Poland
Portugal
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: UMC Utrecht, Department of Neurology, ALS Center

location_facility: Atrium Health Neuroscience Institute - Charlotte

location_facility: University of California Irvine - ALS & Neuromuscular Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Massachusetts Memorial Medical Center/Medical School

location_facility: VCU Neuroscience Orthopaedic and Wellness Center (NOW)

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: Massachusetts General Hospital - Neurological Clinical Research Institute

location_facility: Vanderbilt University Medical Center - Clinical Research Center

location_facility: Maurice Wohl Clinical Neuroscience Institute

location_facility: Centro Clinical Nemo - Fondazione Serena Onlus

location_facility: Centro Hospitalar Universitario Lisboa Norte, Department of Neurology

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: Medical School Hannover - Department of Neurology

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Calgary - Heritage Medical Research Clinic

location_facility: AOU Città della Salute e Scienza (Molinette),

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: RSCI Education and Research Centre, Beaumont Hospital

location_facility: UZ Leuven Gasthuisberg, Department of Neurology

location_facility: McGill University, Montreal Neurological Institute & Hospital

location_facility: CHRU de Tours, Hopital Bretonneau, Clinical Research Center

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

location_facility: Ottawa Hospital Research Institute - Civic Campus

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

location_facility: Studieenheten Akademiskt Specialistcentrum, Sabbatsberg Hospital

location_facility: Washington University School of Medicine - Center for Advance Medicine

summary: The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.


title: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors

acronym: TRUST-II

summary: The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.

lead_sponsor: AnHeart Therapeutics Inc.

location_country:
Spain
Italy
Canada
Korea, Republic of
United States
France
China
Japan

location_facility: Keck Medicine of University of Southern California

location_facility: Humanitas Istituto Clinico Catanese, Misterbinanoco

location_facility: Hospital Regional Universitario de Malaga

location_facility: Chonnam National University Hwasun Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat

location_facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania

location_facility: McGill University Health Centre Research Institute

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico

location_facility: AOU Cagliari- P.O. Policlinico Universitario Duilio Casula

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Pusan National University Yangsan Hospital


title: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

summary: This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of BLU-263 + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or Part 2 will roll over onto Part 3 to receive treatment with BLU-263 in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). The study also includes PK groups that will enroll patients with ISM.

lead_sponsor: Blueprint Medicines Corporation

location_country:
Portugal
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Switzerland
United States
France
Belgium
Germany

location_facility: Hospital Virgen del Valle - Instituto de Estudios de Mastocitosis de Castilla-La Mancha

location_facility: Centro Hospitalar Universitario Sao Joao, E.P.E.

location_facility: Kepler Universitatsklinikum, Med Campus III. Clinic of Internal Medicine 3 - Hematology and Oncology

location_facility: S.S.D. Immunologia Clinica e Allergologia Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

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

location_facility: Michigan Medicine University of Michigan

location_facility: Hôpital Necker - Départementd 'HématologieA dultes

location_facility: Dipartimentod i Oncoematologia Istituto Scientifico Romagnolop er lo studio e la cura dei tumori (IRST)- IRCCS

location_facility: Unita Operativa di Ematologia AOU Policlinico S. Orsola-Malpighi

location_facility: CHUPorto, EPE - Hospital de Santo António

location_facility: SOD Ematologia (Ambulatori)- AOUC Azienda Ospedaliero Universitaria Careggi

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo Antonio dos Capuchos

location_facility: Charité - Universitätsmedizin Berlin Institute of Allergology

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Universitätsmedizin Mannheim III. Medizinische Klinik Universität Heidelberg Medizinische Fakultät Mannheim

location_facility: Universitätsklinikum RWTH Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: Unità Operativa di Allergologia Azienda Ospedaliera Universitaria Integrata di Verona


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk Mortality

acronym: ZENITH

summary: The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

lead_sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

location_country:
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Netherlands
United States
France
Belgium
Germany

location_facility: University of California San Diego Medical Center ( Site 1002)

location_facility: Universitätsklinikum des Saarlandes ( Site 1513)

location_facility: St Vincent's Hospital Sydney ( Site 1102)

location_facility: University of Cincinnati Medical Center ( Site 1035)

location_facility: Centre Hospitalier Universitaire de Toulouse. ( Site 1315)

location_facility: Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Ospedale S. Giuseppe Multimedica ( Site 2403)

location_facility: University of Colorado Hospital ( Site 1013)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: University of New Mexico Health Sciences Center ( Site 1048)

location_facility: University of California Irvine ( Site 1086)

location_facility: Arizona Pulmonary Specialists ( Site 1010)

location_facility: David Geffen School of Medicine at UCLA ( Site 1068)

location_facility: The Cleveland Clinic Foundation. ( Site 1065)

location_facility: Medical University of South Carolina - PPDS ( Site 1003)

location_facility: University of Rochester Medical Center - PPDS ( Site 1039)

location_facility: La Sapienza-Università di Roma-Policlinico Umberto I ( Site 2402)

location_facility: Duke University Medical Center ( Site 1026)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2504)

location_facility: Medizinische Hochschule Hannover ( Site 1505)

location_facility: Medical College of Wisconsin - Froedtert Hospital ( Site 1051)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

location_facility: Hôpitaux Universitaires de Strasbourg ( Site 1307)

location_facility: Statcare Pulmonary Consultants - Knoxville ( Site 1031)

location_facility: CHU de Nancy - Hôpital de Brabois Adultes ( Site 1308)

location_facility: AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

location_facility: University Of Iowa Hospitals And Clinics ( Site 1050)

location_facility: Brigham and Women's Hospital ( Site 1014)


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Brazil
Romania
Spain
Ireland
United Kingdom
Australia
Mexico
Argentina
Puerto Rico
United States
Chile
China
France
Colombia
Japan
Germany

location_facility: The Ohio State University Wexner Medical Center (OSUWMC) - CarePoint East-Rheumatology and Immunolog

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: Amarillo Center for Clinical Research-Research

location_facility: The Center for Rheumatology and Bone Research

location_facility: Greater Chicago Specialty Physicians - Orland Park

location_facility: GCM Medical Group, PSC - Hato Rey Site-Hato Rey

location_facility: Washington University/ Barnes Jewish Hospital

location_facility: Clin-Med Research & Development - 6141 Sunset Drive

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Arthritis & Rheumatology Research Institute

location_facility: Servicos Especializados em Reumatologia SER

location_facility: UCLA Clinical & Translational Research Center (CTRC)

location_facility: Hospital de Base de São José do Rio Preto-CIP - Centro Integrado de Pesquisas

location_facility: Centro de Estudos em Terapias Inovadoras-Rheumatology

location_facility: The Feinstein Institute For Medical Research

summary: The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.


title: Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib

summary: This was an open-label, randomized, dose-finding study in patients with primary or secondary MF (Dynamic International Prognostic Scoring System [DIPSS] risk score of Intermediate-1 to High-Risk) who were previously treated with ruxolitinib. The study was designed to support a pacritinib dosage selection decision with evaluation of 3 dosages.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Verstovsek S, Mesa R, Talpaz M, Kiladjian JJ, Harrison CN, Oh ST, Vannucchi AM, Rampal R, Scott BL, Buckley SA, Craig AR, Roman-Torres K, Mascarenhas JO. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia. Haematologica. 2022 Jul 1;107(7):1599-1607. doi: 10.3324/haematol.2021.279415.

lead_sponsor: CTI BioPharma

location_country:
Spain
Italy
United Kingdom
Hungary
Korea, Republic of
United States
France
Sweden

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

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

location_facility: The University of Chicago Medical Center

location_facility: Washington University School of Medicine in St. Louis

location_facility: UCLA Jonsson Comprehensive Cancer Center

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

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Florida Cancer Specialists & Research Institute

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Toulouse- Hôpital Purpan

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Texas Health Science Center at San Antonio School of Medicine

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

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

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: Northwestern University Feinberg School of Medicine

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

status_simplified: Completed


title: A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)

acronym: PRESERVE 2

summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

ReferenceCitation: Goel S, Tan AR, Rugo HS, Aftimos P, Andrić Z, Beelen A, Zhang J, Yi JS, Malik R, O'Shaughnessy J. Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2. Future Oncol. 2022 Sep 22. doi: 10.2217/fon-2022-0773. [Epub ahead of print] Review.

lead_sponsor: G1 Therapeutics, Inc.

location_country:
Poland
Serbia
Spain
Georgia
Australia
Russian Federation
Ukraine
United States
France
China
Bulgaria
Moldova, Republic of

location_facility: 3337-LTD S.Khechinashvili University Hospital

location_facility: 1249---KP "Volynskyi obl med tsentr onkolohii" VOR

location_facility: Texas Oncology Cancer Care and Research Center (site# 3317)

location_facility: 3154----Hospital Universitario Virgen del Rocío Avenida Manuel Siurot s/n

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research

location_facility: 3102-Peter MacCallum Cancer Centre - Oncology

location_facility: University of Maryland Greenbaum Comprehensive Cancer Ctr-site# 1128

location_facility: 1107-ARENSIA Exploratory Medicine Harmony Health

location_facility: 1153-Clinical Hospital Center "Bezanijska Kosa", Oncology Clinic

location_facility: Florida Cancer Specialists - North (SCRI)

location_facility: 3126-Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine

location_facility: 3266--Cancer Hospital Chinese Academy of Medical Sciences

location_facility: 3132-Leningrad Regional Clinical Oncology Dispensary

location_facility: 3112-LTD "Institute Of Clinical Oncology"

location_facility: 3274---The First Affiliated Hospital of Chongqing Medical University

location_facility: 3205-First Affiliated Hospital of Zhengzhou University

location_facility: 3275-Sun Yat-sen University Cancer Center

location_facility: 3270-- The First Hospital of Jilin University

location_facility: 2822-"High Technology Hospital MedCenter" LTD

location_facility: 3144__Hospital Universitario 12 de Octubre

location_facility: 3161-Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii

location_facility: 2806---Zaporizhzhia Regional Antitumor Center

location_facility: 3143--Hospital Universitari General de Catalunya Servicio de Oncologia

location_facility: 3363-"TIM - Tbilisi Institute of Medicine" LTD

location_facility: 3134-Moscow Regional Oncology Dispensary

location_facility: 3267__Harbin Medical University Cancer Hospital

location_facility: 3111-Consilium Medulla , Multiprofile Clinic

location_facility: 1256-Institute for Personalized Medicine LTD (site #-1256)

location_facility: 1250--"Ternopil obl klin onkodyspanser" TOR

location_facility: 3127- LTDIsraeli-Georgian Medical Research Clinic Helsicore

location_facility: 3101-Institute for Oncology and Radiology of Serbia

location_facility: 3119-31 rue de la Croix Verte , ICM-Val d'Aurelle

location_facility: 1155-University Clinical Center Nis, Oncology Clinic

location_facility: 3342-Hospit.Universit.Infanta, Cristina Servicio Farmacia Planta

location_facility: 1156- Oncology Institute of Vojvodina, Clinic for internal oncology

location_facility: 1255-Ljubljana Str "Tbilisi Cancer Center" LTD

location_facility: 1310_IMSP Institutul Oncologic, ARENSIA Exploratory Medicine

location_facility: 3354-Wojewodzki Szpital Specjali. , Wroclawiu Apteka Szpitalna , ul. H. M. Kamienskiego 73a

location_facility: 1171-Special hospital for Internal diseases Oncomed system, Karposeva 91,

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

location_facility: 3272-The Fourth Hospital of Hebei Medical University


title: A 3-Arm, Randomized, Blinded, Active-Controlled, Phase II Study of RO7121661, a PD1-TIM3 Bispecific Antibody and RO7247669, a PD1-LAG3 Bispecific Antibody, Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Spain
Italy
United Kingdom
Ukraine
South Africa
Belgium
Czechia
Poland
Russian Federation
Argentina
Turkey
Singapore
Kenya
Brazil
Hungary
Germany
Denmark
Taiwan
Thailand
Korea, Republic of
France

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Songklanagarind Hospital; Department of Oncology

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

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: University of Pretoria Oncology Department; Medical Oncology

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Chonnam National University Hwasun Hospital

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Universitätsklinikum Düsseldorf; Klinik für Gastroenterologie Infektologie u. Hepatologie

location_facility: Uzsoki Utcai Korhaz; Onkoradiológiai Osztály

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

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: National Cancer Centre; Medical Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Van Yuzuncu Yil University Hospital; Medical Oncology

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

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

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

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

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: CI of Kherson Regional Council Kherson Regional Oncology Dispensary

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Klinikum Bogenhausen; Klinik für Gastroenterologie, Hepatologie und Gastroenterologische Onkologie

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: National Taiwan University Hospital; Oncology

location_facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

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

location_facility: Seoul National University Bundang Hospital

summary:
This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of RO7121661 and RO7247669, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen.

Following approval of the protocol amendment version 3, recruitment into the RO7121661 arm has been stopped. The decision to stop recruitment for RO7121661 was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for RO7121661 remains unchanged.

The study was planned to enroll participants randomized in a 1:1:1 ratio to receive RO7121661, RO7247669, or nivolumab. With version 3 of the protocol, recruitment into the RO7121661 has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either RO7247669 or nivolumab.


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

lead_sponsor: Alzheon Inc.

type: U.S. NIH Grant/Contract

location_country:
Spain
United Kingdom
Netherlands
Canada
United States
France
Iceland
Germany
Czechia

location_facility: Centre Mémoire de Ressources et de Recherche (CM2R) des Hôpitaux Universitaires de Strasbourg

location_facility: Medica 111, Spol. s.r.o. - Neurologicka a Rehabilitacni Ambulance

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Alzheimer's Research and Treatment Center

location_facility: UCSD Shiley-Marcos Alzheimer's Disease Research Center

location_facility: Fundacia ACE - Institut Catala de Neurociencies Aplicadas

location_facility: Groupe Hospitalier Saint-Louis, Lariboisière, Fernand Widal

location_facility: CHU De Montpellier - Hôpital Gui De Chauliac

location_facility: Hospices Civils de Lyon - Institut du vieillissement

location_facility: Centro Hospital Universitario Dr. Preset

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone

location_facility: CHU Toulouse - Centre de Recherche Clinique du Gérontopôle

location_facility: Wake Research - Clinical Research Center of Nevada

location_facility: Klinikum der Universitaet Muenchen Innenstadt

location_facility: Klinik fuer Psychiatrie und Psychotherapie

location_facility: Kline Institute for Psychiatric Research

location_facility: Uniklinik RWTH Aachen Medizinische Klinik III

location_facility: Memory Clinic Geriatric Department Landspitali University Hospital

location_facility: Fakultní nemocnice u sv. Anny v Brně (St. Anne's University Hospital)

location_facility: Louisiana State University Health Sciences Center (LSUHSC)

summary: This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.