title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Kenya
Brazil
Switzerland
Hungary
China
Germany
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France
Morocco

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Szpital Morski im. PCK; Poradnia Onkologiczna

location_facility: Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

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

location_facility: Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

location_facility: The First Affiliated Hospital to Henan University of Science and Technology

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Subei People's Hospital of Jiangsu province; Respiratory

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: University of Pennsylvania Health System; Cancer Center

location_facility: AUSL-IRCCS di Reggio Emilia; Oncologia Medica

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Fakultni nemocnice Kralovske Vinohrady; Radioterapeuticka a onkologicka klinika

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

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

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Petz Aladar Megyei Oktato Korhaz; Oncoradiologia

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Szegedi Tudományegyetem; Onkoterápiás Klinika

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

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddział Onkologiczny

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology

location_facility: SP ZOZ MSWiA z Warm-Maz Centrum Oncologii w Olsztynie; ZAKŁAD I ODDZIAŁ KLINICZNY RADIOTERAPII

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,

location_facility: Scientific Research Institute n.a. N.N. Petrov

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: Clatterbridge Cancer Centre; Clatterbridge Cancer Centre

location_facility: Affiliated Drum Tower Hospital of Nanjing University Medical School; Nanjing Shi

location_facility: The First People's Hospital of Lian Yun Gang

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

location_facility: Clinique specialise Menara; Oncology Medical

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

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

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

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: National Taiwan University Hospital; Oncology

location_facility: Affiliated Hospital of Bengbu Medical College

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

location_facility: Universitätsklinikum Essen Klinik f.Strahlentherapie

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani

location_facility: University of Pretoria Oncology Department; Medical Oncology

location_facility: Compassionate Care Research Group Inc. Riverside

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Med. Fak. d. Otto-von-Guericke-Universität; Unik. für Gastroenter., Hepat. und Infekt.

location_facility: Centre Hospitalier Universitaire Hassan II

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: The 900th Hospital of PLA joint service support force

location_facility: Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie; Odd. Onk. Klin. i Immunoonk.

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie

location_facility: Saitama Medical University International Medical Center

location_facility: Heping Hospital Affiliated to Changzhi Medical College

location_facility: Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG

location_facility: Instituto de Ensino e Pesquisa Clinica do Ceara

location_facility: Klinikum Klagenfurt am Wörthersee; Abteilung für Innere Medizin und Onkologie

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Washington University School of Medicine; Medical Oncology

location_facility: Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol

location_facility: Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie

location_facility: AKH - Medizinische Universität Wien; Department for Internal Medicine I

location_facility: Städtisches Klinikum Dresden; IV. Medizinische Klinik

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

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

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Affiliated Hospital of Jining Medical University

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

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Viszeralonkologisches Zentrum

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Chulalongkorn Hospital; Medical Oncology

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

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

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

location_facility: Van Yuzuncu Yil University Hospital; Medical Oncology

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Compassionate Care Research Group Inc. Corona

location_facility: CI of Kherson Regional Council Kherson Regional Oncology Dispensary

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Institut National D'oncologie Sidi Med Benabdellah; Oncolgy Medical

location_facility: European Hospital Georges Pompidou (HEGP)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Changzhou Tumor Hospital, Changzhou Fourth People's Hospital

summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis

summary:
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.

The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIa AL amyloidosis.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Poland
Spain
Greece
Austria
Australia
Italy
Canada
Russian Federation
United Kingdom
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

intervention_type: Drug

acronym: A study to assess the efficacy and safety of nemolizumab in subjects with prurigo nodularis

title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

study_completion_date_type: Actual

lead_sponsor: Galderma R&D

type: EudraCT Number

source: euctr

enrollment_type: Actual

location_country:
Poland
Spain
Canada
Switzerland
Korea, Republic of
United States
France
Belgium
Netherlands

summary: The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.

status_simplified: Completed


title: A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma

acronym: CheckMate 7UA

summary: The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Australia
Netherlands
Russian Federation
United Kingdom
Switzerland
Sweden
United States
France
Belgium
Germany

intervention_type: Biological

status_simplified: Unknown


title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.

summary: This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

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
United Kingdom
United States
Peru
Belgium
Japan
Philippines
South Africa
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands


title: A Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

acronym: IONA-MM

summary:
Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months

To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice

To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice

To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)

To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)

Secondary Objective:

Not applicable

study_type: Observational

time_perspective: Prospective

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

lead_sponsor: Sanofi

location_country:
Italy
Austria
Netherlands
Switzerland
Puerto Rico
United States
France
Belgium
Japan
Germany

location_facility:
Investigational site number 2500007
Investigational Site Number 2760015
Investigational site number 0400003
Investigational Site Number 2760034
Investigational Site Number 8400019
Investigational Site Number 2760003
Investigational Site Number 8400025
Investigational Site Number 2760037
Investigational Site Number 8400020
Investigational Site Number 8400007
Investigational Site Number 8400028
Investigational Site Number 8400004
Investigational Site Number 8400023
Investigational Site Number 3920001
Investigational Site Number 3920005
Investigational site number 2500011
Investigational Site Number 3920008
Investigational site number 2500010
Investigational site number 2500005
Investigational Site Number 3800005
Investigational site number 2500003
Investigational Site Number 2760016
Investigational Site Number 8400015
Investigational Site Number 3920010
Investigational Site Number 3800001
Investigational site number 5600002
Investigational Site Number 3920009
Investigational Site Number 2760006
Investigational Site Number 2760041
Investigational Site Number 2760011
Investigational Site Number 8400030
Investigational Site Number 2760007
Investigational Site Number 3920003
Investigational Site Number 8400026
Investigational Site Number 5760002
Investigational Site Number 2760031
Investigational Site Number 2760013
Investigational Site Number 8400017
Investigational Site Number 2760021
Investigational Site Number 2760008
Investigational Site Number 3920004
Investigational Site Number 8400002
Investigational Site Number 8400006
Investigational Site Number 2760009
Investigational site number 2500012
Investigational Site Number 3920006
Investigational Site Number 8400031
Investigational Site Number 2760035
Investigational Site Number 2760012
Investigational Site Number 2500009
Investigational Site Number 8400013
Investigational Site Number 2760014
Investigational Site Number 2760025
Investigational Site Number 3920002
Investigational Site Number 3920011
Investigational site number 2500013
Investigational Site Number 2760040
Investigational Site Number 8400021
Investigational Site Number 8400010
Investigational Site Number 8400016
Investigational site number 2500006
Investigational site number 2500004
Investigational Site Number 8400011
Investigational Site Number 2760036
Investigational Site Number 2760010
Investigational Site Number 2760018
Investigational Site Number 8400018
Investigational Site Number 2760026
Investigational Site Number 2760020
Investigational Site Number 2760019
Investigational site number 2500008
Investigational site number 0400002
Investigational Site Number 5820001
Investigational Site Number 8400009
Investigational Site Number 5760001
Investigational Site Number 3800010
Investigational Site Number 8400024
Investigational Site Number 2760002
Investigational Site Number 3800007
Investigational Site Number 3920007
Investigational Site Number 3920012
Investigational site number 2760001
Investigational site number 2500001
Investigational Site Number 8400001
Investigational Site Number 8400012
Investigational Site Number 5760003
Investigational Site Number 2760017


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)

acronym: PERSEUS

summary:
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

Secondary Objectives:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Sweden
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Belarus
Greece
Latvia
Estonia
France
Chile
Colombia
Netherlands

location_facility: Advanced Neuroscience Center-Site Number:8400035

location_facility: Neurology Center of San Antonio-Site Number:8400036

location_facility: Arcadia Neurology Center-Site Number:8400070

location_facility: Consultants In Neurology-Site Number:8400011

location_facility: Advanced Neurosciences Research-Site Number:8400025

location_facility: South Florida Neurology Associates-Site Number:8400029

location_facility: Mountain View Clinical Research-Site Number:8400024

location_facility: Hackensack University Hospital-Site Number:8400047

location_facility: Jefferson Neurology Associates-Site Number:8400016

location_facility: University of Colorado-Site Number:8400012

location_facility: Meridian Clinical Research, LLC-Site Number:8400005

location_facility: Wake Forest University Baptist Medical Center-Site Number:8400116

location_facility: University of Massachusetts-Site Number:8400014

location_facility: Sharlin Health & Neurology-Site Number:8400093

location_facility: Saint Luke's Hospital-Site Number:8400153

location_facility: University of San Francisco, Sandler Neurosciences Center-Site Number:8400137

location_facility: Beth Israel Deaconess Medical Center-Site Number:8400143

location_facility: Mt Olympus Medical Research-Site Number:8400163

location_facility: Multiple Sclerosis Center of California-Site Number:8400135

location_facility: Medical College of Wisconsin-Site Number:8400028

location_facility: University of Florida, Fixel Center for Neurology-Site Number:8400159

location_facility: International Neurorehabilitation Institute-Site Number:8400034

location_facility: College Park Family Care Certer-Site Number:8400044

location_facility: Wheaton Franciscan Healthcare-Site Number:8400022

location_facility: Hawaii Pacific Neuroscience-Site Number:8400103

location_facility: Duke Neurological Disorders Clinic-Site Number:8400098

location_facility: Michigan Institute For Neurological Disorders-Site Number:8400058

location_facility: University of Kentucky-Site Number:8400106

location_facility: Optimed Research, LTD-Site Number:8400147

location_facility: Collaborative Neuroscience Research-Site Number:8400045

location_facility: University of South Florida-Site Number:8400006

location_facility: Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120

location_facility: The Memorial Hospital-Site Number:8400033

location_facility: Neurology Associates, PA-Site Number:8400004

location_facility: Providence Multiple Sclerosis Center-Site Number:8400020

location_facility: University Of Nebraska-Site Number:8400129

location_facility: Wayne State University-Site Number:8400046

location_facility: Neurology Associates of Stony Brook-Site Number:8400042

location_facility: Prairie Education and Research Cooperative-Site Number:8400071

location_facility: The Ohio State University Wexner Medical Center-Site Number:8400150

location_facility: Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038

location_facility: Ochsner Baptist Clinical Trials Unit (CTU)-Site Number:8400107

location_facility: Tufts Medical Center-Site Number:8400072


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis

summary:
The primary objective of the study is to evaluate the efficacy of dupilumab on the annualized rate of exacerbations in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).

The secondary objectives of the study are:

To evaluate the effects of dupilumab on lung function in participants with ABPA
To evaluate the effects of dupilumab on ABPA-related exacerbations
To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA
To evaluate the effects of dupilumab on asthma control in participants with ABPA
To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA
To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations
To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels
To evaluate safety and tolerability of dupilumab in participants with ABPA
To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA

ReferenceType: derived

ReferenceCitation: Kao CC, Hanania NA, Parulekar AD. The impact of fungal allergic sensitization on asthma. Curr Opin Pulm Med. 2021 Jan;27(1):3-8. doi: 10.1097/MCP.0000000000000740. Review.

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Poland
United Kingdom
Netherlands
Canada
Hungary
United States
France
Romania
Japan
Germany
Bulgaria


title: A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

acronym: GEMINI 2

summary:
Primary Objective:

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

Secondary Objective:

To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

status: Active, not recruiting

location_country:
Croatia
Serbia
Spain
United Kingdom
Ukraine
United States
Belgium
Czechia
Portugal
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Norway
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Greece
Latvia
Korea, Republic of
France
Chile
Netherlands

location_facility: Advanced Neuroscience Center-Site Number:8400035

location_facility: Center for Neurology and Spine-Site Number:8400089

location_facility: Neurology Center of San Antonio-Site Number:8400036

location_facility: Arcadia Neurology Center-Site Number:8400070

location_facility: Consultants In Neurology-Site Number:8400011

location_facility: Advanced Neurosciences Research-Site Number:8400025

location_facility: South Florida Neurology Associates-Site Number:8400029

location_facility: Minneapolis Clinic of Neurology-Site Number:8400051

location_facility: Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151

location_facility: Hackensack University Hospital-Site Number:8400047

location_facility: Jefferson Neurology Associates-Site Number:8400016

location_facility: Meridian Clinical Research, LLC-Site Number:8400005

location_facility: Saint Luke's Hospital-Site Number:8400153

location_facility: Sibyl Wray, MD, Neurology, PC-Site Number:8400007

location_facility: Mt Olympus Medical Research-Site Number:8400163

location_facility: Multiple Sclerosis Center of California-Site Number:8400135

location_facility: University of New Mexico-Site Number:8400032

location_facility: International Neurorehabilitation Institute-Site Number:8400034

location_facility: Wheaton Franciscan Healthcare-Site Number:8400022

location_facility: University of Florida Health-Site Number:8400159

location_facility: West Omaha Family Physicians-Site Number:8400139

location_facility: Mountain Neurological Research Center, Inc.-Site Number:8400128

location_facility: CHI Saint Joseph Medical Group Neurology-Site Number:8400110

location_facility: North Central Neurology Associates, PC-Site Number:8400009

location_facility: South Shore Neurologic Associates-Site Number:8400100

location_facility: Sanford Brain & Spine Center-Site Number:8400126

location_facility: Fort Wayne Neurological Center-Site Number:8400039

location_facility: Infinity Clinical Research-Site Number:8400008

location_facility: Norton Neurology MS Services-Site Number:8400127

location_facility: Dayton Center for Neurological Disorders-Site Number:8400081

location_facility: Meridian Clinical Research-Site Number:8400003

location_facility: The NeuroMedical Center-Site Number:8400057


title: A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

acronym: OSCAR

summary: OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Brazil
Spain
Colombia
Italy
Mexico
Russian Federation
Argentina
Canada
United Kingdom
United States
Chile
France
India
Belgium
Japan
Netherlands
Peru
South Africa


acronym: PEVENAZA

title: A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

lead_sponsor: Takeda

type: Registry Identifier

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

location_country:
Poland
Italy
Canada
United States
France

location_facility: AdventHealth (Florida Hospital) - Transplant Institute

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: University of North Carolina at Chapel Hill

location_facility: Institut dHematologie de Basse Normandie

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: University of Miami Miller School of Medicine

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

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

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

summary:
The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy.

Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin).

Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.


acronym: DOR/ISL Blinded Label Switch

title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
Austria
Australia
Finland
Canada
Puerto Rico
United States
France
Japan
Germany

location_facility: Vancouver ID Research and Care Centre Society ( Site 2800)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 3601)

location_facility: University of California, Davis, Division of ID Research ( Site 2702)

location_facility: Triple O Research Institute, P.A. ( Site 2755)

location_facility: The Crofoot Research Center, Inc. ( Site 2715)

location_facility: National Hospital Organization Osaka National Hospital ( Site 7202)

location_facility: Hospital Universitari de Bellvitge ( Site 3612)

location_facility: Holdsworth House Medical Practice ( Site 3800)

location_facility: Taylor Square Private Clinic ( Site 3804)

location_facility: Kaiser Permanente Los Angeles Medical Center ( Site 2775)

location_facility: Midway Immunology and Research ( Site 2759)

location_facility: Holdsworth House Medical Practice - Brisbane ( Site 3810)

location_facility: Hospital 12 de Octubre de Madrid ( Site 3605)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 3603)

location_facility: Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)

location_facility: Hospital Universitario Ramon y Cajal ( Site 3611)

location_facility: Centre Hospitalier Regional du Orleans ( Site 3108)

location_facility: Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)

location_facility: Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)

location_facility: Hospital Clinic i Provincial ( Site 3600)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 3128)

location_facility: Prahran Market Clinic (PMC) ( Site 3806)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)

location_facility: Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 7203)

location_facility: Hospital Universitario La Paz ( Site 3604)

location_facility: Klinikum rechts der Isar der Technischen Universitat ( Site 3005)

location_facility: Chatham County Health Department ( Site 2731)

location_facility: Centre Hospitalier de Tourcoing ( Site 3100)

location_facility: Clinical Research Puerto Rico Inc ( Site 2900)

location_facility: Azienda Ospedaliera San Paolo ( Site 3503)

location_facility: Hospital Universitari Vall d Hebron ( Site 3602)

location_facility: A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 7201)

location_facility: Hospital Universitario Infanta Leonor ( Site 3606)

location_facility: MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 2719)

location_facility: Hope Clinical Research, Inc. ( Site 2902)

location_facility: North Texas ID Consultants, PA ( Site 2707)

location_facility: Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)

location_facility: Hennepin County Medical Center ( Site 2733)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 3609)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 2700)

location_facility: CHU de Nice Hopital Archet 1 ( Site 3103)

location_facility: Universitaetsklinikum Essen ( Site 3007)

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)

location_facility: Helsinki University Hospital ( Site 3200)

location_facility: CAIMED Center - Ponce School of Medicine ( Site 2903)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 3404)

location_facility: ICH Study Center GmbH & Co.KG ( Site 3009)

location_facility: Medizinische Hochschule Hannover ( Site 3012)

location_facility: DCOL Center for Clinical Research ( Site 2769)

location_facility: Zuckerberg San Francisco General Hospital UCSF ( Site 2743)

summary: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.


title: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

lead_sponsor: Loxo Oncology, Inc.

ReferenceCitation: Wirth LJ, Brose MS, Elisei R, Capdevila J, Hoff AO, Hu MI, Tahara M, Robinson B, Gao M, Xia M, Maeda P, Sherman E. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naïve RET-mutant medullary thyroid cancer. Future Oncol. 2022 Sep;18(28):3143-3150. doi: 10.2217/fon-2022-0657. Epub 2022 Aug 15. Review.

ReferenceCitation: Jaber T, Dadu R, Hu MI. Medullary thyroid carcinoma. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):540-546. doi: 10.1097/MED.0000000000000662. Review.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
India
Israel
Brazil
Canada
China
Germany
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (policlinic, hospital)

location_facility: Azienda Ospedaliero-Universitaria S.Giovanni Battista

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

location_facility: University of California, Davis - Health Systems

location_facility: National medical research center of radiology Obninsk

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Hopital Pitie Salpetriere -Unité Thyroïde-Tumeurs Endocrines

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Harbin Medical University Cancer Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: London Health Science Centre - Victoria Hospital

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

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: National Medical Research Center of Endocrinology of Ministry of Health Dept

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Los Angeles Biomedical Research Institute at Harbor - UCLA Medical

location_facility: Beijing Tongren Hospital affiliated to Capital Medical Unive

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: West China Hospital of Sichuan University

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Seoul National University Bundang Hospital

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: Klinikum der Universität München Großhadern

location_facility: Studiengesellschaft Hämato-Onkologie Hamburg - Prof Laack & Partner

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: University of Cincinnati Cancer Institute

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Ospedale San Luca, IRCCS Istituto Auxologico

location_facility: University General Hospital of Heraklion

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

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek

location_facility: Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.


title: An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)

location_country:
Poland
Taiwan
Spain
Ireland
United Kingdom
Canada
Ukraine
Hungary
Korea, Republic of
France
United States
Chile
Colombia
Japan
Germany

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)

location_facility: Massachusetts General Hospital ( Site 0155)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 1001)

location_facility: Hospital Clinic I Provincial de Barcelona ( Site 0702)

location_facility: Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)

location_facility: China Medical University Hospital ( Site 2302)

location_facility: The Christie NHS Foundation Trust ( Site 0914)

location_facility: Fundacion Arturo Lopez Perez ( Site 0500)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)

location_facility: Georgia Cancer Center at Augusta University ( Site 0129)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1506)

location_facility: Hospital General Arnau de Vilanova de Valencia ( Site 0706)

location_facility: Princess Margaret Cancer Centre ( Site 0005)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0501)

location_facility: CI Krivorizhskiy oncology dispensery ( Site 1504)

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

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1203)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 1520)

location_facility: McGill University Health Centre ( Site 0002)

location_facility: Texas Oncology-San Antonio Northeast ( Site 0165)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 0156)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 0158)

location_facility: Kyungpook National University Chilgok Hospital ( Site 2402)

location_facility: Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

location_facility: Fukushima Medical University Hospital ( Site 2201)

location_facility: Virginia Piper Cancer Institute ( Site 0157)

location_facility: John Wayne Cancer Institute ( Site 0111)

location_facility: Texas Oncology - San Antonio Stone Oak ( Site 0166)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0510)

location_facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

location_facility: St Vincents University Hospital ( Site 0900)

location_facility: Seoul National University Bundang Hospital ( Site 2409)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1600)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

location_facility: SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)

location_facility: Severance Hospital Yonsei University Health System ( Site 2401)

location_facility: Clinica Universitaria Navarra - Madrid ( Site 0700)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 1009)

location_facility: Hyogo College of Medicine Hospital ( Site 2203)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 22

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

location_facility: The Center For Cancer And Blood Disorders ( Site 0151)

location_facility: Zhytomyr Regional Oncology Center ( Site 1515)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)

location_facility: Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

location_facility: Hospital Universitario Reina Sofia ( Site 0705)

location_facility: Gachon University Gil Medical Center ( Site 2408)

location_facility: Aichi Cancer Center Hospital ( Site 2202)

location_facility: University of Miami Sylvester CC ( Site 0146)

location_facility: Virginia Oncology Associates ( Site 0163)

location_facility: Universitaetsklinikum Mannheim GmbH ( Site 1213)

location_facility: CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)

location_facility: Medical Centre Consilium Medical ( Site 1514)

location_facility: Blackpool Victoria Hospital ( Site 0921)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)

location_facility: Seoul National University Hospital ( Site 2403)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

location_facility: Virginia Oncology Associates ( Site 0153)

location_facility: Universitaetsklinikum Erlangen ( Site 1201)

location_facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)

location_facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)

location_facility: Mercy Clinic Oncology and Hematology ( Site 0110)

location_facility: Orszagos Onkologiai Intezet ( Site 1602)

location_facility: St. Joseph Heritage Healthcare ( Site 0104)

location_facility: Texas Oncology-New Braunfels ( Site 0168)

location_facility: YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)

location_facility: National Cheng Kung University Hospital ( Site 2303)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1605)

location_facility: Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)

location_facility: Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

location_facility: Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

location_facility: Virginia Oncology Associates ( Site 0164)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1517)

location_facility: Medical Centre LLC Oncolife ( Site 1510)

location_facility: Hospital Universitari Vall d Hebron ( Site 0701)

summary:
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:

Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS).
Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS).


title: A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

lead_sponsor: Eisai Inc.

ReferenceCitation: Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.

ReferenceCitation: Gaspar N, Campbell-Hewson Q, Huang J, Okpara CE, Bautista F. OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma. Future Oncol. 2021 Nov;17(32):4249-4261. doi: 10.2217/fon-2021-0743. Epub 2021 Aug 12.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Hong Kong
Austria
Australia
Israel
Sweden
Singapore
Canada
Switzerland
Taiwan
Ireland
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Schneider Children's Medical Center of Israel

location_facility: Severance Hospital Yonsei University Health System

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: University of Mississippi Medical Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Drottning Silvias Barn Och Ungdomssjukhus

summary: This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.


title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

acronym: CheckMate 7FL

summary: A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Romania
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Ireland
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Azienda Ospedaliero-Universitaria Mater Domini

location_facility: American Oncology Partners of Maryland, PA

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Centre Hospitalier de l'Université de Montréal-Breast Cancer

location_facility: Centre Hospitalier intercommunal de Toulon La Seyne sur Mer


acronym: RAGNAR

title: A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

lead_sponsor: Janssen Research & Development, LLC

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

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Sweden
Korea, Republic of
United States
France
China
Belgium
Japan
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: Instituto de Investigaciones Metabólicas

location_facility: Medizinische Fakultät Carl Gustav Carus Technische Universität Dresden

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Third Military Medical University Daping Hospital Cancer Center

location_facility: Central South University Xiangya Hospital The First Affiliated Hospital of Hunan Medical College

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Ospedale Santa Chiara AO Universitaria Pisana

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Beijing Luhe Hospital, Capital Medical University

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Eastern Theater General Hospital, Qinhuai District Medical Area

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Flinders Centre for Innovation in Cancer

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

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

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

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Intergrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Texas Oncology Odessa-West Texas Cancer Center

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

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

location_facility: First affiliated Hospital of Zhejiang University

summary: The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.


acronym: QUASAR

title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Malaysia
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Jordan
Ireland
Latvia
New Zealand
Korea, Republic of
France
Netherlands

location_facility: University of North Carolina at Chapel Hill

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: The Second Affiliated Hospital of Zhejiang University

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Tianjin Medical University General Hospital

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'

location_facility: Tongji Hospital, Tongji Medical College of HUST

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

location_facility: Gastroenterology Associates of Tidewater

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: The First Affiliated Hospital of NanChang University

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Gastroenterology Associates of Orangeburg, SC

location_facility: Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'

location_facility: SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'

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

location_facility: Seoul National University Bundang Hospital

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Gastroenterology Department GASTROMART s.r.o.

location_facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

location_facility: UF Health Jacksonville Gastroenterology- Emerson

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

location_facility: Universitätsklinikum Salzburg - Landeskrankenhaus

location_facility: The Second Hospital Affiliated To Suzhou University

location_facility: First Affiliated Hospital of Kunming Medical Unversity

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: Hospital de Alta Complejidad en Red 'El Cruce'

location_facility: The first affiliated hospital of suzhou University

location_facility: Gastroenterologie, s.r.o., Hradec Kralove

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

location_facility: Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways

location_facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

location_facility: Pauls Stradins Clinical University Hospital

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

location_facility: Harmony Medical Research Institute, Inc.

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika

location_facility: NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway

location_facility: Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: All-Russian Center of Emergency and Radiation Medicine MCRS

location_facility: Semmelweis Egyetem, Ii. Belgyogyaszati Klinika

location_facility: The second Xiangya Hospital of Central South University

location_facility: The Second Hospital To Dalian Medical University

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

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

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Hospital General de Agudos José Maria Ramos Mejía

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: Universitaetsklinikum Charite, Campus Virchow Klinikum

location_facility: Capital Medical University, Beijing Friendship Hospital

location_facility: Asclepiades - interna a gastroenterologie s.r.o

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Toronto Immune & Digestive Health Institute Inc.

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Gastroenterolgy Associates of Central GA

location_facility: NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Japan Community Health Care Organization Saitama Medical Center

location_facility: Accout Center, s.r.o., Gastroenterologická ambulancia

location_facility: Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy

location_facility: Sai Clinic, Gastrointestinal and Protology Divisions

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

location_facility: Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: West China Hospital of Sichuan University

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Sumy State University, Sumy Regional Clinical Hospital

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

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

location_facility: National Hospital Organization Kochi National Hospital

location_facility: Mersin University Medical Faculty Hospital

summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).


title: A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

location_country:
Poland
Brazil
Spain
Greece
Ireland
Australia
Italy
Canada
New Zealand
Russian Federation
United Kingdom
United States
France
Belgium
Japan
Germany

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Genesis Care Tugun - John Flynn Private Hospital

location_facility: University of Athens - Hospital of Venereology Dermatology Diseases Andreas Syggros

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

location_facility: SBHI of Stavropol Region Pyatigorsk Interdistrict Oncology Dispensary

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon - Hopital du Bocage

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

location_facility: Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

location_facility: Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

location_facility: Hospital Clinico Universitario de Salamanca

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

location_facility: Central Coast Cancer Centre-Gosford and Wyong Hospitals

location_facility: Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

location_facility: Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon

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

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Western General Hospital - Nhs Lothian - Lothian University Hospitals Division

location_facility: Ashford Cancer Centre Research-Adelaide Cancer Centre

location_facility: Narodowy Instytut Onkologii im. Marii Sk¿odowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach

location_facility: Hospital Universitario Virgen Macarena-merge

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

location_facility: Wide Bay Hospital and Health Service - Cancer Care Services - Hervey Bay

location_facility: Centre Hospitalier Universitaire de Nice,Hopital l Archet

location_facility: The Christie - The Christie NHS Foundation Trust

location_facility: U.O.S.C Di Oncologia Medica E Terapie Innovative

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

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Sarah Cannon Research Institute - Tennessee Oncology

location_facility: Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

location_facility: Cancer Care Associates (CCA) Riverina Cancer Care Centre (RCCC)

location_facility: University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

location_facility: Hospital General Universitario Gregorio Maranon (HGUGM)

location_facility: Federal State Budgetary Institution Rostov Research Institute of Oncology of the Ministry of Healthcare of the Russian Federation

location_facility: University College Cork-Cork University Maternity Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute

location_facility: Hospital das Clinicas da Faculdade de Medician de Ribeirao Preto FMRP USP

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Universita di Firenze - Azienda Sanitaria Firenze

location_facility: St George's Hospital - St George's University Hospitals NHS Foundation Trust

location_facility: The Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre

location_facility: NCT Dermatoonkologie -Hautklinik Heidelberg

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

location_facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

location_facility: Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC) - Unidade I

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: A. Gemelli University Hospital, Catholic University of the Sacred Heart

location_facility: The Townsville Hospital and Health Service

location_facility: University of Missouri Health Care - University Physicians - Medicine Specialty Clinic

location_facility: University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre

location_facility: George Washington University School of Medicine and Health Sciences

location_facility: University Health Network- Princess Margaret Cancer Center

location_facility: Universitair Ziekenhuis Leuven Gasthuisberg Campus

location_facility: Olivia Newton -John Cancer Wellness & Research Centre

location_facility: National Cancer Center Hospital - Gastrointestinal Oncology

location_facility: Hospital Universitario y Politecnico La Fe-merge

location_facility: State Healthcare Institution Oncology Dispensary 2 Ministry of Healthcare of Krasnodar Region

summary:
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).

The secondary objectives of the study are:

To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
To assess cemiplimab pharmacokinetics and immunogenicity in human serum


intervention_type: Procedure

title: A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)

ReferenceCitation: Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Russian Federation
Australia
Israel
Turkey
Mexico
Sweden
Canada
Hungary
Germany
Denmark
Ireland
Thailand
Korea, Republic of
France

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)

location_facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

location_facility: Tokushima University Hospital ( Site 1514)

location_facility: Hospital Universitario Quiron Madrid ( Site 0657)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)

location_facility: H. de Gerona Dr. Josep Trueta ( Site 0651)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0959)

location_facility: Odense Universitetshospital ( Site 0403)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)

location_facility: Inova Schar Cancer Institute ( Site 0007)

location_facility: University Hospital Waterford ( Site 0723)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)

location_facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1452)

location_facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)

location_facility: Leningrad Regional Oncology Center ( Site 0868)

location_facility: Clinical Hospital Saint Luka ( Site 0867)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0865)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0810)

location_facility: Universitaetsklinikum Erlangen ( Site 0505)

location_facility: Lviv Regional Clinical Hospital ( Site 0955)

location_facility: Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

location_facility: Imperial College Healthcare NHS Trust ( Site 0721)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

location_facility: Sapporo Medical University Hospital ( Site 1501)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

location_facility: Providence Saint John's Health Center ( Site 0075)

location_facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)

location_facility: Yitzhak Shamir Medical Center ( Site 0805)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0856)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

location_facility: Clinic of Bashkortostan State Medical University ( Site 0869)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)

location_facility: Central Texas Veterans Healthcare System ( Site 0057)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0662)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)

location_facility: Nara Medical University Hospital ( Site 1510)

location_facility: Osaka Metropolitan University Hospital ( Site 1512)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 1513)

location_facility: UMass Memorial Medical Center ( Site 0051)

location_facility: Kent and Canterbury Hospital ( Site 0709)

location_facility: The Royal Marsden Foundation Trust ( Site 0702)

location_facility: Instituto Nacional de Cancerologia ( Site 0256)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

location_facility: CNPE "Regional Center of Oncology" ( Site 0958)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 1057)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)

location_facility: Nova Scotia Health Authority ( Site 0109)

location_facility: Mid North Coast Cancer Institute ( Site 1256)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)

location_facility: University Hospitals Cleveland Medical Center ( Site 0038)

location_facility: Hospital San Pedro de Alcantara ( Site 0654)

location_facility: Tallaght University Hospital ( Site 0710)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0802)

location_facility: Georgetown University Medical Center ( Site 0022)

location_facility: Southside Cancer Care Centre ( Site 1252)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

location_facility: Peninsula Health Frankston Hospital ( Site 1258)

location_facility: Seoul National University Hospital ( Site 1352)

location_facility: Policlinico Gemelli di Roma ( Site 0558)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1517)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0253)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0560)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

location_facility: Sunnybrook Research Institute ( Site 0110)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0660)

location_facility: Hospital Universitario San Carlos ( Site 0663)

location_facility: Rigshospitalet University Hospital ( Site 0401)

location_facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)

location_facility: Saitama Medical University International Medical Center ( Site 1505)

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

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)

location_facility: New England Cancer Specialists ( Site 0070)

location_facility: University of Tsukuba Hospital ( Site 1503)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0515)

location_facility: Seoul National University Bundang Hospital ( Site 1356)

location_facility: Korea University Anam Hospital ( Site 1351)

location_facility: Regional Oncological Hospital ( Site 0956)

location_facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0554)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 0913)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 1051)

location_facility: Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0557)

location_facility: National Cancer Center Hospital East ( Site 1504)

location_facility: CHU UCL Namur Site de Godinne ( Site 0354)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)

location_facility: Hirosaki University Hospital ( Site 1502)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0519)

location_facility: Hospital Nuestra Sra. de Valme ( Site 0658)

location_facility: Herlev og Gentofte Hospital. ( Site 0402)

location_facility: Charleston Area Medical Center ( Site 0023)

location_facility: Northwest Medical Specialties, PLLC ( Site 0061)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 0852)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Shaare Zedek Medical Center ( Site 0809)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

location_facility: New York University Perlmutter Cancer Center ( Site 0008)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0911)

location_facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

location_facility: FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru

location_facility: Kingston Health Sciences Centre ( Site 0103)

location_facility: Hospital Universitario La Paz ( Site 0661)

location_facility: Kyiv City Clinical Oncology Center ( Site 0960)

summary: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.


title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

summary: The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

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

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

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

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: Kobe City Medical Center General Hospital

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

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

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

location_facility: The First Hospital of Chinese Medical University

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

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Instituto Médico de la Fundación Estudios Clínicos

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

location_facility: University of Florida College of Medicine

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University of Utah Health Sciences Center

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

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Seoul National University Bundang Hospital

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

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

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

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

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: University of Texas Southwestern Medical Center

location_facility: National Hospital Organization Himeji Medical Center


title: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

acronym: FLOW

summary: The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

ReferenceCitation: Cohen S, Sternlicht H, Bakris GL. Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists. Curr Diab Rep. 2022 May;22(5):213-218. doi: 10.1007/s11892-022-01461-4. Epub 2022 Apr 20. Review.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Poland
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Malaysia
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Greece
Thailand
France
Netherlands


title: A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.

lead_sponsor: Celgene

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

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Providence Cancer Center/Earle A. Chiles Res. Inst.

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Washington University School of Medicine

location_facility: Washington University School Of Medicine

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Derriford Hospital, University Hospitals Plymouth NHS Trust

location_facility: University of Pittsburgh Medical Center - Cancer Pavilion

location_facility: Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M

location_facility: NYU Langone Laura and Isaac Perlmutter Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center


ipd_sharing: No

status: Terminated

primary_purpose: Prevention

acronym: POLAR-M

title: A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC

lead_sponsor: Egetis Therapeutics

ReferenceCitation: Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Hungary
Korea, Republic of
France
United States
Belgium
Japan
Germany
Czechia

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centre Hospitalier Départemental de Vendée - Unité de recherche clinique

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet

location_facility: NCKUH: National Cheng Kung University Hospital

location_facility: Hôpital Nord Franche-Comté Site du Mittan

location_facility: National Hospital Organization Osaka National Hospital

location_facility: KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Mid Florida Hematology and Oncology Center

summary: This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.