title: A Phase III, Multicentre, International Study With a Parallel, Randomised, Double-blind, Placebo-controlled, 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET)

acronym: KOMET

summary: A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

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

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

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

lead_sponsor: AstraZeneca

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
United States
France
China
Japan
Germany


title: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin

acronym: COMPOSE

summary: The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

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: ITM Solucin GmbH

location_country:
Spain
Italy
United Kingdom
Australia
Sweden
India
United States
France
Netherlands

location_facility: Washington University Alvin J. Siteman Cancer Center

location_facility: ICO Hospitalet, Catalan Institute of Oncology

location_facility: Nantes University Hospital Center - Hotel Dieu Hospital

location_facility: University Hospital Vall d'Hebron, Department of Medical Oncology

location_facility: University and Polytechnic Hospital La Fe, Endocrinology

location_facility: VU Medical Center (VUMC), Department of Medical Oncology

location_facility: University of Colorado Hospital, Nuclear Medicine

location_facility: IUCT Oncopole - Institut Universitaire du Cancer de Toulouse

location_facility: University Hospital Complex of Santiago (CHUS)

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: All India Institute Of Medical Sciences, Nuclear Medicine

location_facility: University Hospital 12 de Octubre, Department of Gastroenterology

location_facility: University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology

location_facility: Duke University School of Medicine, Duke Cancer Institute

location_facility: Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology

location_facility: Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging

location_facility: Edouard Herriot Hospital, Medical Oncology Unit

location_facility: University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine

location_facility: Mayo Clinic - Rochester, Department of Oncology

location_facility: Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Registry Identifier

type: EudraCT Number

type: Other Identifier

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 Lung Cancer or Pleural Mesothelioma

summary:
Primary Objective:

-To determine the antitumor activity of SAR444245 in combination with other anticancer therapies.

Secondary Objectives:

To confirm the dose and to assess the safety profile of SAR444245 when combined with other anticancer therapies.
To assess other indicators of antitumor activity.
To assess the pharmacokinetic (PK) profile of SAR444245 when given in combination with pembrolizumab.
To assess the immunogenicity of SAR444245.

status: Active, not recruiting

design_allocation: Non-Randomized

ipd_sharing: Yes

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
Australia
Argentina
Korea, Republic of
United States
Chile
France
Puerto Rico
Japan

location_facility: Thomas Jefferson University - North East-Site Number:8401009

location_facility: Oncology Health Group-Site Number:8400001

location_facility: Cleveland Clinic Foundation-Site Number:8400004

location_facility: Thomas Jefferson University Hospital-Site Number:8400009

location_facility: Mount Sinai Medical Center-Site Number:8400006

location_facility: The Sarah Cannon Research Institute-Site Number:8400003

location_facility: Hematology Oncology Clinic-Site Number:8400010

intervention_type: Drug


title: A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

lead_sponsor: Bristol-Myers Squibb

source: euctr

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
Argentina
Switzerland
United States
France
Mexico
Japan
Germany
Czechia

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

location_facility: Arthritis & Osteoporosis Associates - Freehold

location_facility: St Joseph Heritage Healthcare-Rheumatology

location_facility: Barbara Davis Center for Childhood Diabetes-Rheumatology

location_facility: CHU Strasbourg-Hautepierre-Service de Rhumatologie

summary: The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.


title: A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults

acronym: DYNAMIC

summary: The purpose of this study is to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants will be randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams [mgs]) or a reference arm of blinded 3TC-each in combination with open label DTG.

enrollment_type: Actual

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country:
Portugal
Spain
Italy
Argentina
Canada
Puerto Rico
United States
France
South Africa
Germany


title: A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

summary:
Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed.

Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide.

In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.

status: Terminated

study_completion_date_type: Actual

ipd_sharing: No

lead_sponsor: AbbVie

location_country:
Spain
United Kingdom
Australia
United States
Israel
France
Japan
Germany

location_facility: National Cancer Center Hospital East /ID# 241834

location_facility: University of Kentucky Markey Cancer Center /ID# 229506

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 228332

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 229473

location_facility: Columbia University Medical Center /ID# 229971

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 228328

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 241833

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 229356

location_facility: Hospital Universitario 12 de Octubre /ID# 229355

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 228323

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 230291

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 229354

location_facility: The Queen Elizabeth Hospital /ID# 229345

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309

location_facility: University of Texas Southwestern Medical Center /ID# 228830

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 229141

location_facility: Hospital Santa Creu i Sant Pau /ID# 229369

location_facility: Rutgers Cancer Institute of New Jersey /ID# 230174

location_facility: Perelman Center for Advanced Medicine - /ID# 228693

location_facility: Tel Aviv Sourasky Medical Center /ID# 229478

location_facility: The Chaim Sheba Medical Center /ID# 229483

location_facility: Universitaetsklinik Heidelberg /ID# 229145

location_facility: Norton Cancer Institute - St Matthews /ID# 229319

location_facility: Hospital Universitario Reina Sofia /ID# 229388

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 228559

location_facility: National Hospital Organization Mito Medical Center /ID# 244043

location_facility: Nagoya City University Hospital /ID# 241835

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 230007

location_facility: Sylvester Comprehensive Cancer Center /ID# 228817

location_facility: Hospital Parc de Salut del Mar /ID# 229371

location_facility: St Vincent's Hospital Melbourne /ID# 229349

location_facility: Hadassah Medical Center-Hebrew University /ID# 229477

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 228333

location_facility: Japanese Red Cross Medical Center /ID# 241836

location_facility: University of Arizona Cancer Center - Tucson /ID# 229696

intervention_type: Biological

status_simplified: Unknown


title: A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea®, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration

acronym: Mylight

summary:
Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD.

The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

lead_sponsor: Sandoz

location_country:
Poland
Portugal
Spain
Latvia
Austria
Australia
Lithuania
Hungary
United States
France
Israel
Japan
Germany
Bulgaria
Slovakia
Czechia


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Poland
Spain
Italy
Russian Federation
Canada
Korea, Republic of
United States
France

location_facility: Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

location_facility: Georgia Cancer Center at Augusta University

location_facility: Almazov National Medical Research Center

location_facility: National Medical Research Center of Hematology

location_facility: Azienda Ospedaliero - Universitaria Mater Domini

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Argentina
Canada
Switzerland
United States
France
China
India
Belgium
Israel
Germany
Turkey
Japan
Czechia

summary: The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.


title: A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

acronym: topMIND

summary: The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.

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

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

lead_sponsor: Incyte Corporation

location_country:
Spain
Italy
Austria
United States
France
Belgium
Germany

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital General Universitario de Valencia

location_facility: Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

location_facility: Hospital General Universitario Vall D Hebron

location_facility: S Orsolas University Hospital Seragnoli Institute of Hematology

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Hospital General Unviersitario de Alicante

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Hospital Clinico Universitario de Salamanca

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

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center


title: Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.

summary:
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine.

Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

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

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

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Israel
Malaysia
Singapore
Canada
Hungary
China
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE - Unidade Hospitalar de Vila Real

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

location_facility: Institute for Clinical and Experimental Medicine

location_facility: The First Affiliated Hospital of Wenzhou Med College

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: University Clinical Center Professor Gibinskiego

location_facility: IRCCS Ospedale "Casa Sollievo della Sofferenza"

location_facility: General Oncology Hospital "Agioi Anargyri"

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

location_facility: Niigata University Medical and Dental Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: General Hospital of Thessaloniki "Hippokrateio"

location_facility: National Diabetes and Obesity Research Institute

location_facility: First People's hospital of Yunann Province

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

location_facility: Tokyo Medical and Dental University Hospital

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

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: Lady Davis Carmel Medical Center, Haifa 34362

location_facility: Synexus Polska sp. z o.o. Oddzial w Poznaniu, Poznan

location_facility: The First Afiliated Hospital, Sun Yet-sen University

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: National Chen Kung University, Dept of Neurology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa

location_facility: Private health care facility "Your Health EL" LLC

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE-T)

acronym: ENERGIZE-T

summary: The primary purpose of this study is to compare the effect of mitapivat versus placebo on transfusion burden in participants with transfusion-dependent alpha- or beta-thalassemia (TDT).

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Denmark
Taiwan
Brazil
Saudi Arabia
Greece
Italy
Lebanon
Netherlands
Canada
Spain
Thailand
United Arab Emirates
United Kingdom
United States
France
Malaysia
Turkey
Germany
Bulgaria
Egypt

location_facility: Amsterdam Universitair Medisch Centrum, Locatie AMC

location_facility: Toronto General Hospital, University Health Network

location_facility: Abul Reesh Children's Hospital, Cairo University

location_facility: Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Manchester Royal Infirmary, Manchester University NHS Foundation Trust

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School

location_facility: Seattle Cancer Care Alliance, University of Washington

location_facility: King Abdullah International Medical Research Center

location_facility: AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo

location_facility: Research Institute for Languages and Cultures of Asia, Mahidol University

location_facility: HEMORIO Instituto Nacional de Hematologia

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Clinical Research Center, Cairo University

location_facility: Penn Medicine - University of Pennsylvania Health System

location_facility: Charité - UB - CVK - Medizinische Klinik

location_facility: Centro Microcitemia-Ospedale SS. Annunziata

location_facility: Srinagarind Hospital, Khon Kaen University


title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

acronym: COAST

summary: A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

lead_sponsor: Opthea Limited

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Philippines
Czechia
Poland
Austria
Australia
Argentina
Puerto Rico
India
Israel
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
Estonia
Korea, Republic of
France
Colombia
Netherlands

location_facility:
COAST Investigational Study
COAST
COAST Investigational site
COAST Invesigational Site
COAST Investigational Site


title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD

acronym: ShORe

summary: A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Czechia
Poland
Russian Federation
Australia
Argentina
India
Israel
Malaysia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Thailand
Korea, Republic of
France
Colombia

location_facility:
ShORe Investigational Site
ShORe Investiagtional Site
ShORe Investigational site
ShORe Investiagational Site


title: A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

summary: This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.

lead_sponsor: Adaptimmune

location_country:
United Kingdom
Spain
Canada
United States
France

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

location_facility: Providence Cancer Institute Franz Clinic

location_facility: University Of Texas, MD Anderson Cancer Center

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

location_facility: Washington University School of Medicine- Siteman Cancer Center

location_facility: University Of Wisconsin Clinical Science Center

location_facility: McGill University Health Centre Glen Site

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Kansas Clinical Research Center

location_facility: Hospital Universitario Madrid Sanchinarro (CIOCC)

intervention_type: Genetic


title: Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

location_country:
Spain
United Kingdom
United States
South Africa
Japan
Czechia
Poland
Portugal
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Norway
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Korea, Republic of
France
Chile
Netherlands

location_facility: Renstar Medical Research-Site Number:8400015

location_facility: American Health Research-Site Number:8400002

location_facility: New York - Presbyterian Queens-Site Number:8400028

location_facility: Clinical Research Of West Florida Inc-Site Number:8400008

location_facility: OK Clinical Research LLC-Site Number:8400001

location_facility: BRCR Medical Center, Inc.-Site Number:8400190

location_facility: IMA Clinical Research, LLC-Site Number:8400027

location_facility: Sarasota Memorial Health Care System Clinical ResearchCenter-Site Number:8400178

location_facility: Smart Medical Research-Site Number:8400191

location_facility: Revive Research Institute-Site Number:8400186

location_facility: Clinical Trials Center of Middle Tennessee-Site Number:8400025

location_facility: North Georgia Clinical Research-Site Number:8400013

location_facility: Schenectady Pulmonary and Critical Care Associates-Site Number:8400029

location_facility: Illinois Lung Institute-Site Number:8400024

location_facility: Advanced Respiratory and Sleep Medicine-Site Number:8400022

location_facility: Agile Clinical Research Trial, LLC-Site Number:8400177

location_facility: Finlay Medical Research-Site Number:8400007

location_facility: Sierra Clinical Research-Site Number:8400005

location_facility: Phoenix Medical Research-Site Number:8400019

location_facility: Advanced Pulmonary Research Institute-Site Number:8400018

location_facility: Midwest Pulmonology, Critical Care and Sleep Associates-Site Number:8400033

location_facility: Toledo Institute of Clinical Research-Site Number:8400014

location_facility: Probe Clinical Research Corporation-Site Number:8400188

location_facility: North Florida/South Georgia Veterans Health System-Site Number:8400176

location_facility: Palmtree Clinical Research-Site Number:8400184

location_facility: Genesis Clinical Research, LLC-Site Number:8400182

location_facility: Lowcountry Lung & Critical Care-Site Number:8400175

location_facility: Sun Research Institute-Site Number:8400183

location_facility: Washington University School of Medicine-Site Number:8400035

location_facility: Meris Clinical Research-Site Number:8400021

location_facility: Y and L Advance Health Care, Inc D/B/A Elite Clinical Res-Site Number:8400009

location_facility: Finlay Medical Research-Site Number:8400011

location_facility: VitaLink Research- Gaffney-Site Number:8400003

location_facility: TriWest Research Associates-Site Number:8400185

summary:
Primary Objective:

Primary population (former smokers cohort):

Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD

Secondary Objectives:

Primary population (former smokers cohort):

Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Secondary population (current smokers cohort)

Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD


title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis

acronym: FILLMORE

summary: Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

status: Completed

lead_sponsor: Applied Molecular Transport

location_country:
Spain
United Kingdom
Netherlands
Canada
Switzerland
Hungary
United States
France
Belgium
Germany

location_facility: Praxis fur Gastroenterologie am Bayerischen Platz

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: University of Utah Health Sciences Center

location_facility: Groupe santé CHC / Clinique du MontLégia, Liege

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: Semmelweis Egyetem I. sz Belgyogyaszati Klinika

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Gastrointestinal Asssociates- GIA Clinical Trials, LLC

status_simplified: Completed


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

acronym: COMINO

summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

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).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
United States
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Singapore
Brazil
Hungary
China
Germany
Taiwan
Korea, Republic of
France

location_facility: Northern California Retina Vitreous Associates

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

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

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Ośrodek Chirurgii Oka Prof. Zagórskiego Nałęczów

location_facility: University Retina and Macula Associates, PC

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Northwestern Medical Group/Northwestern University

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: Tokyo Women's Medical University Hospital

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: California Eye Specialists Medical group Inc.

location_facility: Kansai Medical University Medical Center

location_facility: Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe

location_facility: General Teaching Hospital Prague; Ophthalmology clinic

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Seoul National University Bundang Hospital

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Retina Consultants of Southern Colorado PC

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: The 2nd Affiliated Hospital of Harbin Medical University

location_facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: Queen Mary Hospital; Department of Ophthalmology

intervention_type: Procedure


title: Randomised, Double-blind, Double-dummy, Multicentre Trial to Evaluate the Efficacy and Safety of Three Different Weekly Dosages of Calcifediol Versus Placebo in Subjects With Either Vitamin D Deficiency or Insufficiency.

acronym: WORFEROL

summary: This is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin D deficiency or insufficiency. Its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (SGCs) compared to placebo.

lead_sponsor: Faes Farma, S.A.

location_country: Serbia Spain Italy France Bulgaria Slovakia Czechia

location_facility: KARDIO 1, s.r.o., Kardiologická ambulancia

location_facility: ALERSA, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: ALERGO H2B, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: ANA JJ, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: Pľúcna ambulancia Hrebenár, s.r.o. - Pneumologicko-ftizeologická ambulancia

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Azienda Ospedaliero Universitaria - Università degli Studi della Campania Luigi Vanvitelli - UOC di Medicina Fisica e Riabilitazione

location_facility: AOU Pisana - Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci

location_facility: IN MEDIC s.r.o., Neurologická ambulancia

location_facility: Zoll-Med, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: MEDILEX, s.r.o., Ambulancia vnútorného lekárstva

location_facility: Medical Centre Asklepion - Research in human medicine

location_facility: Klinički centar Kragujevac, Centar za reumatologiju, alergologiju i kliničku imunologiju, Odeljenje za reumatologiju

location_facility: Poliklinika Choceň - Neurologická ambulance

location_facility: UOC di Riabilitazione -Azienda Ospedaliero Universitaria Paolo Giaccone Palermo

location_facility: Opšta bolnica "Đorđe Joanović" Zrenjanin, Odeljenje za reumatologiju

location_facility: Institut za lečenje i rehabilitaciju "Niška Banja" Niš, Klinika za reumatologiju

location_facility: IRCCS Ospedale San Raffaele /Unità di Endocrinologia

location_facility: Klinički centar Vojvodine, Klinika za endokrinologiju, dijabetes i bolesti metabolizma

location_facility: Fondazione PTV -Policlinico Ospedaliero Universitario Tor Vergata - U.O.C. Ortopedia e Traumatologia

location_facility: Endomed, s.r.o. - Gastroenterologická ambulancia

location_facility: Individual Practice Ambulatory for Specialized Medical Care - Cardiology, Obstetrics and Gynecology

location_facility: Centrum gynekologické rehabilitace s.r.o.

location_facility: Centrum pro diagnostiku a léčbu myasthenia gravis - Neurologická klinika 1. LF UK a VFN v Praze

location_facility: RS centrum - Neurologická klinika 1.LF UK a VFN v Praze

location_facility: Diagnostic & Consultative Center "Sveta Anna" EOOD

location_facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico -UOC Endocrinologia e Malattie Metaboliche

location_facility: DANIMED, s.r.o., Ambulancia klinickej imunológie a alergológie

location_facility: Kardioamb, s.r.o., Kardiologická a interná ambulancia

location_facility: KK Neuro, s.r.o., Neurologická ambulancia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Specijalna bolnica za reumatske bolesti Novi Sad


title: A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

summary: A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

lead_sponsor: BeiGene

location_country:
Taiwan
Spain
Thailand
Korea, Republic of
France
China

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Quanzhou First Hospital of Fujian Province

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Guangdong Provincial Hospital of Chinese Medicine

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: General Hospital of Ningxia Medical University

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: The Second Hospital of Anhui Medical University

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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

location_facility: Hwa Mei Hospital, University of Chinese Academy of Sciences

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Hospital Regional Universitario de Málaga

location_facility: Heping Hospital Affiliated to Changzhi Medical College

location_facility: Meizhou Hospital Affiliated to Sun Yat-sen University

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: The First People's Hospital of Changzhou

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Hospital Clinico Universitario de Valencia - Incliva

location_facility: The First Affiliated Hospital of Nanchang University

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

location_facility: Hopital Europeen Georges Pompidou - Digestive Oncology

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Affiliated Hospital of Jiangnan University

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Centre Hospitalier Universitaire d'Amiens - Hopital Sud


acronym: PIVOT IO 020

title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

location_country:
Spain
Italy
Australia
United States
France
Germany

location_facility:
Local Institution - 0015
Local Institution - 0037
Local Institution - 0002
Local Institution - 0001
Local Institution - 0003
Local Institution - 0038
Local Institution - 0027
Local Institution - 0011
Local Institution - 0014
Local Institution - 0016
Local Institution - 0009
Local Institution - 0008
Local Institution - 0059
Local Institution - 0039
Local Institution - 0029
Local Institution - 0013
Local Institution
Local Institution - 0028

summary: The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.


title: A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension

summary: The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.

lead_sponsor: Altavant Sciences GmbH

location_country:
Poland
Bosnia and Herzegovina
Serbia
Spain
Italy
Austria
Latvia
United Kingdom
Canada
Ukraine
United States
France
Belgium
Germany
Bulgaria
Moldova, Republic of
Czechia

location_facility: Universitätsklinikum Giessen und Marburg

location_facility: Umberto I Policlinico di Roma, Università La Sapienza

location_facility: Washington University School of Medicine

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: George Washington University Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Brown University - Rhode Island Hospital

location_facility: Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina

location_facility: Dnipropetrovsk Regional Clinical Diagnostic Center

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Brigham and Women's Hospital (BWH), Harvard Medical School

location_facility: UZ Leuven - Campus Gasthuisberg - Pneumologie

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Jeffrey S. Sager, MD Medical Corporation

location_facility: University of California San Diego Health Sciences

location_facility: University of New Mexico Heath Science Center

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: University of North Carolina Medical Center - Chapel Hill

location_facility: University Health Network, Toronto General Hospital

location_facility: Institute for Cardiovascular diseases of Vojvodina

location_facility: AKH- Wien, Medizinische Univsersität Wien


title: A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients With Relapsed or Refractory Follicular Lymphoma (LOTIS 6)

acronym: LOTIS 6

summary: This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.

lead_sponsor: ADC Therapeutics S.A.

location_country:
Poland
Spain
Italy
United Kingdom
Switzerland
Hungary
United States
France
Israel
Belgium

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Hospital Universitario Quirónsalud Madrid

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

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain

location_facility: Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

location_facility: Account University College London Hospitals NHS Foundation Trust

location_facility: Summit Medical Group - Florham Park Campus

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Comprehensive Cancer Centers of Nevada - Central Valley

location_facility: Hospital Universitario Fundación Jiménez Díaz


title: GRECO-2: A Randomized, Phase 2b Study of GC4711 in Combination With Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Unresectable or Borderline Resectable Nonmetastatic Pancreatic Cancer

summary: GTI-4711-201 is designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the effect to OS by adding GC4711 to SBRT following chemotherapy in patients with unresectable or borderline resectable nonmetastatic

ReferenceType: derived

ReferenceCitation: Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347.

lead_sponsor: Galera Therapeutics, Inc.

location_country:
United Kingdom
United States
Canada
France

location_facility: Radiation Oncology and Gamma Knife Center of Oregon

location_facility: University of Iowa Hospitals and Clinics

location_facility: Institut régional du Cancer de Montpellier


title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry

acronym: CHOICE-MI

summary: This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_country:
Denmark
United Kingdom
Italy
Australia
Canada
Switzerland
United States
France
Norway
Germany

location_facility: Heart Center of the University Medical Center Mainz

location_facility: University Heart and Vascular Center Hamburg

location_facility: Rikshospitalet, Oslo University Hospital (OUS)

location_facility: Goethe-Universität - University Hospital Frankfurt

location_facility: Cedars-Sinai Medical Center, Los Angeles

lead_sponsor_type: academique


title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

acronym: ASSERT

summary: Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

lead_sponsor: Albireo

location_country:
Poland
United Kingdom
Italy
Netherlands
New Zealand
Canada
United States
France
Israel
Malaysia
Belgium
Turkey
Germany

location_facility: The Childrens Hospital at Montefiore Albert Einstein School of Medicine

location_facility: Oregon Health Science University School of Medicine

location_facility: Cliniques Universitaires Saint-Luc Bruxelles

location_facility: Universitätsklinik für Kinder-und Jugendmedizin Tübingen

location_facility: Antenne pédiatrique du CIC - Hopital Jeanne De Flandre

location_facility: Istanbul University Medical Faculty Hospital

location_facility: Hacettepe Üniversitesi İhsan Doğramacı Çocuk Hastanesi

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Schneider Children's Medical Center of Israel

location_facility: University of California - San Francisco


title: A Phase IIIb, Global, Multicenter, Randomized, Visual Assessor-Masked Study Of The Efficacy, Safety, And Pharmacokinetics Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

summary: Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

status: Suspended

location_country:
Taiwan
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Switzerland
Korea, Republic of
France
Israel
Singapore
Turkey
Belgium
Germany

location_facility: Inselspital Bern Ophthalmologische Klinik

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital; Ophthalmology

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Stadtspital Triemli Ophthalmologische Klinik

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

location_facility: Seoul National University Bundang Hospital

location_facility: Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: Universitätsklinikum Ulm, Augenklinik und Poliklinik

location_facility: Universitätsspital Basel Augenklinik Klinik

location_facility: Fondation Asile Des Aveugles - Jules Gonin Eye Hospital

location_facility: LMU Klinikum der Universität, Augenklinik

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

intervention_type: Device


title: A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination With JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

summary: The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

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:
Poland
Spain
Georgia
Australia
Ukraine
Korea, Republic of
United States
France
Israel
Belgium
Netherlands
Moldova, Republic of

location_facility: Medical Center of Limited Liability Company Arensia Exploratory Medicine


title: Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

lead_sponsor: Sanofi

location_country:
Portugal
Italy
Greece
Australia
Puerto Rico
United States
France
Norway

location_facility: University of Illinois-Site Number:8400007

location_facility: University of Michigan-Site Number:8400004

location_facility: Roswell Park Cancer Institute-Site Number:8400008

location_facility: Puerto Rico Medical Research Center, LLC-Site Number:8400005

summary:
Primary Objectives:

Part 1 (dose finding, experimental substudies):

-To determine or confirm the recommended dose of novel agents when combined with isatuximab with or without dexamethasone in participants with RRMM.

Part 2 (expansion, experimental substudies):

To demonstrate the clinical benefit of novel agents combined with isatuximab with or without dexamethasone in terms of rate of very good partial response (VGPR) or better

Secondary Objectives:

-Master Protocol and Substudy 1-ACT16482-01 (Control Arm):
To assess the overall response rate (ORR) in each treatment arm.
To assess the clinical benefit rate (CBR) in each treatment arm.
To assess the duration of response (DOR) in each treatment arm.
To assess the time to first response (TT1R) in each treatment arm.
To assess the time to best response (TTBR) in each treatment arm.
To assess safety and tolerability in each treatment arm.
To assess progression free survival (PFS) in each treatment arm.
To assess overall survival (OS) in each treatment arm.
To evaluate the potential immunogenicity of isatuximab and novel agents when applicable.
To characterize the PK of isatuximab and novel agents.
To assess disease and treatment related symptoms, cancer and disease specific health-related quality of life, global impact of side effects and confirm/establish clinically meaningful change scores for clinical outcome assessments (COAs)/domain scores.
-Substudy 3-ACT16482-03:
To assess patient-reported visual functioning.


title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.

summary: This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

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:
Spain
Italy
United States
Peru
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Israel
Turkey
Singapore
Brazil
Canada
Hungary
Taiwan
Greece
Vietnam
Korea, Republic of
France
Netherlands


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Combined Phase 2a/2b Study to Assess the Efficacy and Safety of BAY 1817080 in Patients With Diabetic Neuropathic Pain

summary:
People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). There are treatments for DNP but in many patients they do not reach a good pain reduction and have unwanted side effects.

In this trial, the researchers will look at how BAY1817080 works and how safe it is. They will compare it to a placebo or another treatment for DNP called pregabalin. A placebo looks like a treatment but does not have any medicine in it. The researchers will use a placebo to learn if the participants' results are due to BAY1817080 or if the results could be due to chance. The researchers will also learn more about the right dose of BAY1817080 for these participants.

The trial will include participants who have DNP and either type 1 or type 2 diabetes. It will include about 440 men and women who are at least 18 years old.

This trial will have 2 parts. In Part 1, the participants will take either BAY1817080 or the placebo. These treatments will be taken as a tablet by mouth twice a day for 8 weeks. In Part 2, participants will take BAY 1817080, pregabalin, or a matching placebo of either treatment. BAY1817080 and a placebo will be taken as a tablet by mouth twice a day for 12 weeks. Pregabalin and a placebo will be taken as a capsule by mouth twice a day for 12 weeks.

The participants in Part 1 will visit their trial site 6 times. The participants in Part 2 will visit their trial site 7 times. At these visits, the doctors will ask the participants if they have any health problems, take blood samples, and do a physical exam. They will also ask the participants to complete questionnaires about their pain and other symptoms.

ReferenceCitation: Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3.

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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

lead_sponsor: Bayer

location_country: Denmark Poland Finland Sweden Hungary France Norway Germany Slovakia Czechia

location_facility: Diabetologicka a endokrinologicka ambulance, Milan Kvapil,

location_facility: Diamond Clinic Specjalistyczne Poradnie Lekarskie

location_facility: Turun yliopistollinen keskussairaala, kantasairaala

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu


acronym: THEIA

title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

location_country:
Poland
Spain
Italy
Canada
United States
France
Israel
Belgium
Germany

location_facility: Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico

location_facility: ASUI Santa Maria della Misericordia di Udine

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

summary: The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).


acronym: Substudy 03B: Phase 1b/2 Umbrella Study of Combination Therapies in RCC

title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03B

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
United Kingdom
Australia
New Zealand
Canada
Korea, Republic of
United States
Israel
France

location_facility: Memorial Sloan Kettering Cancer Center ( Site 3002)

location_facility: The Christie NHS Foundation Trust ( Site 3400)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 3016)

location_facility: Institut De Cancerologie De Lorraine ( Site 3204)

location_facility: Hospital Universitario Ramon y Cajal ( Site 3301)

location_facility: Royal Brisbane and Women s Hospital ( Site 3603)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 3500)

location_facility: Sheba Medical Center - Oncology Division ( Site 3501)

location_facility: Velindre Cancer Centre Hospital ( Site 3407)

location_facility: Hospital Universitari Vall d Hebron ( Site 3300)

location_facility: Princess Margaret Cancer Centre ( Site 3101)

location_facility: Vanderbilt University Medical Center ( Site 3004)

location_facility: Western Sydney Local Health District ( Site 3601)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 3017)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 3405)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 3011)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 3203)

location_facility: Southampton General Hospital ( Site 3403)

location_facility: Hadassah Medical Center-Oncology ( Site 3504)

summary:
Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.


acronym: Substudy 03A: Phase 1b/2 Umbrella Study of Combination Therapies in RCC

title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 1016)

location_facility: Hospital Universitari Vall d Hebron ( Site 1300)

location_facility: Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 1017)

location_facility: Royal Brisbane and Women s Hospital ( Site 1603)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1405)

location_facility: Western Sydney Local Health District ( Site 1601)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)

location_facility: Institut De Cancerologie De Lorraine ( Site 1204)

location_facility: Southampton General Hospital ( Site 1403)

location_facility: Hadassah Medical Center-Oncology ( Site 1504)

location_facility: The Christie NHS Foundation Trust ( Site 1400)

location_facility: Princess Margaret Cancer Centre ( Site 1101)

location_facility: Velindre Cancer Centre Hospital ( Site 1407)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1002)

location_facility: Sheba Medical Center - Oncology Division ( Site 1501)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

summary:
Substudy 03A is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.


title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

summary: This study will assess the safety and efficacy of VS-6766 monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

lead_sponsor: Verastem, Inc.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Belgium

location_facility: Washington University School of Medicine

location_facility: H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Cleveland Clinic Women's Health Institute

location_facility: Centre de recherche di Centre Hospitalier de i'Universite de Montreal

location_facility: The Ohio State University Wexner Medical Center

location_facility: Willamette Valley Cancer Institute and Research Center


title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)

summary: This study will assess the safety and efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

ReferenceCitation: Capelletto E, Bironzo P, Denis L, Koustenis A, Bungaro M, Novello S. Single agent VS-6766 or VS-6766 plus defactinib in KRAS-mutant non-small-cell lung cancer: the RAMP-202 phase II trial. Future Oncol. 2022 May;18(16):1907-1915. doi: 10.2217/fon-2021-1582. Epub 2022 Mar 14. Review.

location_country:
Spain
Italy
United States
France
Germany

location_facility: Complejo Hospitalario Universiario a Coruna Teresa

location_facility: University of Chicago Medical Center-Duchossois Center for Advanced Medicine

location_facility: Cancerologie Gustave Roussy - Cancer Medicine

location_facility: Henry Ford Cancer Institute/Henry Ford Health System

location_facility: Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie Medicale

location_facility: Hospital Universitario Virgen de la Macarena


title: An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination With Durvalumab in Participants With Select Advanced/Metastatic Solid Tumors

summary: Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced/metastatic solid tumors.

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

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

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

location_country:
United States
France


title: An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus

acronym: ADDRESS+

summary:
This is a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provides extension of efgartigimod PH20 SC treatment and retreatment options for participants who have been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and the first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to placebo arm in trial ARGX-113-1904. Trial ARGX-113-1905 evaluates ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CRmin, and the ability to treat flare; and assess patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial.

Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration

lead_sponsor: argenx

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Japan
Poland
Russian Federation
Australia
India
Israel
Turkey
Hungary
China
Germany
Bulgaria
Greece
Georgia
France

location_facility:
Investigator site 85 - IL9720002
Investigator site 58 - ES0340028
Investigator site 1 - US0010087
Investigator site 67 - JP0810043
Investigator site 3 - BG3590011
Investigator site 101 - CN0860017
Investigator site 41 - RU0070033
Investigator site 49 - RU0070030
Investigator site 64 - TR0900020
Investigator site 75 - UA3800017
Investigator site 40 - RU0070035
Investigator site 53 - DE0490023
Investigator site 93 - DE0490027
Investigator site 38 - IT0390031
Investigator site 82 - JP0810046
Investigator site 106 - UK0440021
Investigator site 77 - FR0330028
Investigator site 114 - JP0810067
Investigator site 52 - DE0490001
Investigator site 95 - IT0390039
Investigator site 66 - JP0810042
Investigator site 103 - US0010097
Investigator site 45 - DE0490029
Investigator site 32 - GE9950013
Investigator 96 - RO0400014
Investigator site 19 - DE0490025
Investigator site 92 - AU0610013
Investigator site 37 - GR030006
Investigator site 110 - RS3810010
Investigator site 47 - RU0070028
Investigator site 42 - ES0340025
Investigator site 20 - DE0490002
Investigator site 44 - US0010106
Investigator site 69 - JP0810050
Investigator site 43 - UA3800021
Investigator site 7 - ES0340029
Investigator site 112 - CN0860019
Investigator site 60 - FR0330027
Investigator site 48 - RU0070029
Investigator site 100 - CN0860021
Investigator site 107 - CN0860018
Investigator site 6 - HU0360003
Investigator site 26 - PL0480028
Investigator site 76 - US0010096
Investigator site 9 - UA3800018
Investigator site 72 - JP0810045
Investigator site 65 - IN0910002
Investigator site 34 - DE0490030
Investigator site 105 - RS3810012
Investigator site 28 - PL0480025
Investigator site 88 - US0010114
Investigator site 102 - CN0860020
Investigator site 57 - ES0340027
Investigator site 104 - RS3810009
Investigator site 79 - IN0910004
Investigator site 22 - GR030003
Investigator site 15 - AU0610006
Investigator site 89 - US0010091
Investigator site 21 - GR030004
Investigator site 90 - US0010117
Investigator site 71 - JP0810049
Investigator site 23 - GR030005
Investigator site 14 - UA3800020
Investigator site 62 - ES0340026
Investigator site 27 - PL0480027
Investigator site 94 - IN0910001
Investigator site 99 - CN0860016
Investigator site 50 - RU0070034
Investigator site 55 - IT0390038
Investigator site 2 - BG3590010
Investigator site 108 - FR0330029
Investigator site 39 - RU0070032
Investigator site 84 - US0010089
Investigator site 70 - JP0810041
Investigator site 73 - JP0810047
Investigator site 63 - TR0900012
Investigator site 35 - DE0490028
Investigator site 87 - US0010084
Investigator site 78 - GE9950014
Investigator site 98 - RO0400015
Investigator site 29 - UA3800023
Investigator site 68 - JP0810040
Investigator site 83 - UK0440022
Investigator site 113 - CN0860024
Investigator site 8 - UA3800019
Investigator site 11 - AU0610007
Investigator site 111 - US0010098
Investigator site 25 - IT-0390005
Investigator site 12 - IT0390006
Investigator site 56 - PL0480032
Investigator site 97 - RO0400013
Investigator site 36 - GR0300002
Investigator site 54 - GR0300001
Investigator site 13 - ES0340032
Investigator site 61 - IT0390040
Investigator site 10 - US0010088
Investigator site 18 - BG3590013
Investigator site 80 - IN0910003
Investigator site 74 - TR0900011
Investigator site 17 - BG3590012
Investigator site 33 - DE0490024
Investigator site 81 - IT0390030
Investigator site 91 - US0010109
Investigator site 4 - DE0490026
Investigator site 30 - US0010094
Investigator site 51 - FR0330026
Investigator site 16 - BG3590009
Investigator site 24 - HU0360002
Investigator site 31 - GE9950015
Investigator site 5 - HU0360001
Investigator site 109 - RS3810011
Investigator site 46 - RU0070031
Investigator site 59 - ES0340034
Investigator site 86 - PL0480036
Investigator site 115 - US0010086


title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)

acronym: ADDRESS

summary: This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a screening period of up to 3 weeks, a treatment period of up to 30 weeks, and an 8-week follow-up period for participants who do not enroll into the open-label extension (OLE) trial ARGX-113-1905. The primary objective of the ARGX-113-1904 trial is to demonstrate the efficacy of subcutaneous administration of efgartigimod co-formulated with recombinant human hyaluronidase PH20 (Efgartigimod PH20 SC) compared to placebo in the treatment of participants with Pemphigus Vulgaris (PV). Secondary objectives are to also demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with Pemphigus Foliaceus (PF), and to demonstrate early onset of action and a prednisone-sparing effect. After confirmation of eligibility, participants will be randomized in a 2: 1 ratio to receive efgartigimod PH20 SC or placebo

location_facility:
Investigator site 70 - IT0390038
Investigator site 92 - IT0390030
Investigator site 111 - CN0860018
Investigator site 9 - US0010099
Investigator site 14 - HU0360001
Investigator site 95 - PL0480036
Investigator site 7 - ES0340028
Investigator site 60 - US0010096
Investigator site 77 - US0010086
Investigator site 57 - RU0070029
Investigator site 2 - US0010087
Investigator site 2 - BG3590009
Investigator site 29 - ES0340026
Investigator site 35 - GE9950013
Investigator site 1 - US0010084
Investigator site 43 - IT390005
Investigator site 116 - RS3810011
Investigator site 26 - PL0480027
Investigator site 28 - PL0480028
Investigator site 48 - DE0490030
Investigator site 126 - US0010182
Investigator site 6 - ES0340027
Investigator site 125 - US0010153
Investigator site 109 - CN0860021
Investigator site 33 - FR0330027
Investigator site 62 - UA3800021
Investigator site 72 - PL0480032
Investigator site 22 - HU0360003
Investigator site 83 - JP0810043
Investigator site 12 - ISR9720002
Investigator site 107 - RO0400015
Investigator site 75 - TR0900012
Investigator site 63 - GE9950014
Investigator site 39 - GR0300003
Investigator site 100 - IN0910001
Investigator site 18 - UA3800019
Investigator site 106 - RO0400013
Investigator site 120 - CN0860022
Investigator site 32 - FR0330026
Investigator site 121 - US0010092
Investigator site 119 - CN0860024
Investigator site 41 - GR0300005
Investigator site 78 - US0010109
Investigator site 27 - PL0480025
Investigator site 71 - IT0390040
Investigator site 99 - US0010117
Investigator site 37 - DE0490002
Investigator site 13 - BG3590011
Investigator site 102 - US0010098
Investigator site 91 - IN0910003
Investigator site 44 - US0010101
Investigator site 58 - RU0070033
Investigator site 38 - DE0490028
Investigator site 80 - IN0910002
Investigator site 42 - HU0360002
Investigator site 47 - DE0490023
Investigator site 88 - US0010114
Investigator site 98 - US0010107
Investigator site 122 - RS3810010
Investigator site 85 - JP0810050
Investigator site 104 - IT0390039
Invetistigator site 8 - ES0340029
Investigator site 82 - JP0810042
Investigator site 114 - RS3810009
Investigator site 40 - GR0300004
Investigator site 115 - RS3810012
Investigator site 56 - RU0070031
Investigator site 117 - UK0440021
Investigator site 74 - JP0810045
Investigator site 23 - ES0340031
Investigator site 49 - DE0490024
Investigator site 55 - RU0070030
Investigator site 11 - IT0390006
Investigator site 20 - US0010094
Investigator site 5 - AU0610007
Investigator site 108 - CN0860016
Investigator site 45 - UA3800023
Investigator site 89 - UA3800017
Investigator site 19 - US0010088
Investigator site 113 - CN0860025
Investigator site 46 - FR0330029
Investigator site 79 - DE0490027
Investigator site 17 - UA3800018
Investigator site 30 - BG350012
Investigator site 96 - UK0440022
Investigator site 34 - FR0330028
Investigator site 93 - JP0810041
Investigator site 73 - US00100
Investigator site 69 - GR0300001
Investigator site 21 - DE0490026
Investigator site 81 - JP0810040
Investigator site 4 - BG3590010
Investigator site 84 - JP0810047
Investigator site 61 - US0010090
Investigator site 64 - DE0490029
Investigator site 97 - US0010091
Investigator site 65 - RU0070034
Investigator site 16 - UA3800020
Investigator site 36 - GE9950015
Investigator site 123 - CN0860019
Investigator site 86 - JP0810049
Investigator site 110 - CN0860017
Investigator site 67 - ES0340034
Investigator site 127 - US0010155
Investigator site 50 - GR0300002
Investigator site 87 - TR0900011
Investigator site 124 - JP0810067
Investigator site 66 - RU0070028
Investigator site 24 - AU0610006
Investigator site 51 - GR0300006
Investigator site 68 - DE0490001
Investigator site 54 - RU0070035
Investigator site 112 - CN0860020
Investigator site 10 - ES0340025
Investigator site 53 - RU0070032
Investigator site 25 - DE0490025
Investigator site 94 - JP0810046
Investigator site 105 - RO0400014
Investigator site 103 - AU0610013
Investigator site 52 - IT0390031
Investigator site 59 - US0010106
Investigator site 31 - BG3590013
Investigator site 15 - ES0340032
Investigator site 101 - US0010097
Investigator site 76 - TR0900020
Investigator site 118 - CN0860023
Investigator site 90 - IN0910004


title: EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Madsen RR, Semple RK. PIK3CA-related overgrowth: silver bullets from the cancer arsenal? Trends Mol Med. 2022 Apr;28(4):255-257. doi: 10.1016/j.molmed.2022.02.009. Epub 2022 Mar 8.

location_country:
Hong Kong
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
United States
France
China
Norway
Germany

location_facility: Children's Hospital and Regional Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Cincinnati Children s Hospital Medical Center

summary: This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).


ipd_sharing: Undecided

title: A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

lead_sponsor: Mitsubishi Tanabe Pharma Development America, Inc.

location_country:
Italy
Canada
United States
France
Japan
Germany

location_facility: University of Colorado Anschutz Medical Campus

location_facility: National Hospital Organization Iou National Hospital

location_facility: Johns Hopkins University School of Medicine

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: National Hospital Organization Toneyama Medical Center

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: Heritage Medical Research Clinic - University Of Calgary

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

location_facility: Montreal Neurological Institute and Hospital

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: National Hospital Organization Kumamoto Saishun Medical Center

location_facility: Shiga University of Medical Science Hospital

location_facility: Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

location_facility: Niigata University Medical And Dental Hospital

location_facility: Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

location_facility: Kansai Electric Power Hospital Recruiting

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Tokyo Metropolitan Neurological Hospital

location_facility: University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

summary: This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.


title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis

acronym: AHFIRM

summary: This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

lead_sponsor: Durect

location_country:
United Kingdom
Austria
Australia
United States
France
Belgium

location_facility: University Hospitals Plymouth NHS Trust - Derriford Hospital

location_facility: Washington University School of Medicine

location_facility: University of Nebraska Medical Center (UNMC)

location_facility: Harborview Medical Center - University of Washington

location_facility: Saint Luke's Health System - Saint Luke's Hospital of Kansas City

location_facility: University of California Davis (UC Davis) Medical Center

location_facility: Northwell Health - North Shore University Hospital

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

location_facility: Medical University of South Carolina (MUSC) Health - University Medical Center

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz

location_facility: Keck Hospital of University of Southern California (USC)

location_facility: Baylor College of Medicine Medical Center

location_facility: University of California San Francisco (UCSF) Medical Center

location_facility: New York-Presbyterian - Weill Cornell Medical Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre

location_facility: MedStar Health - MedStar Georgetown University Hospital

location_facility: University of Texas Health (UTHealth) Science Center at Houston

location_facility: University of Virginia (UVA) Health - University Hospital

location_facility: Landeskrankenhaus (LKH) - Universitätsklinikum Graz

location_facility: Université libre de Bruxelles (ULB) - Hôpital Erasme

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: Utah Health - The University of Utah Hospital

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


title: A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome

acronym: TWINSS Extn

summary: This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201(NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.

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

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

location_country:
United Kingdom
Italy
United States
Romania
Japan
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Brazil
Canada
Hungary
Germany
Greece
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

summary: This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, PK, PDy, and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic CCA and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3).

lead_sponsor: Relay Therapeutics, Inc.

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Sweden
Korea, Republic of
United States
France
Singapore
Germany

location_facility: Taussig Cancer Institute Cleveland Clinic

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Hospital Universitario Fundación Jiménez Díaz- START MADRID

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

location_facility: Hospital Clínico Universitario de Valencia

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

location_facility: Huntsman Cancer Institute, University of Utah


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

summary:
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.

Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

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

lead_sponsor: Hoffmann-La Roche

location_country:
Taiwan
New Zealand
Korea, Republic of
Israel
United States
China
France

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Rabin Medical Center-Beilinson Campus; Davidof Institute

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: University of California San Francisco Cancer Center; Pharmacy