title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

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

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

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
United Kingdom
Japan
Switzerland
Austria
Belgium
United States
Spain
Canada
France

location_facility: Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

location_facility: Washington University School of Medicine

location_facility: Oxford University Hospitals Nhs Foundation Trust

location_facility: Emory University - Winship Cancer Institute

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz


type: Other Identifier

type: EudraCT Number

title: An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

summary: This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery
diposit.ub.edu

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ipd_sharing: No

lead_sponsor: Eisai Co., Ltd.

sponsor_collaborators:
Eisai Co., Ltd.
Merck Sharp & Dohme LLC

location_country:
Italy
United Kingdom
Japan
United States
Spain
Russian Federation
France

location_facility: Hôpital Haut-Levêque Centre médico-chirurgical Magellan

location_facility: St. Petersburg City Clinical Oncology Dispansery

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: S.I. Russian Oncological Research Center n.a. N. N. Blokhin RAMS

location_facility: California Pacific Medical Center (CPMC)

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

acronym: CheckMate 592

summary: The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Yale University

location_country:
Germany
Italy
Romania
Netherlands
Belgium
United States
Spain
France

location_facility:
Local Institution - 0017
Local Institution - 0029
Local Institution - 0031
Local Institution - 0030
Local Institution - 0003
Local Institution - 0018
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0015
Local Institution - 0027
Local Institution - 0007
Local Institution - 0002
Local Institution - 0032
Local Institution - 0039
Local Institution - 0038
Local Institution - 0024
Local Institution - 0028
Local Institution - 0005
Local Institution - 0014
Local Institution - 0034
Local Institution - 0012
Local Institution - 0016
Local Institution - 0033
Local Institution - 0001
Local Institution - 0023
Local Institution - 0008
Local Institution - 0022
Local Institution - 0013
Local Institution - 0025
Local Institution - 0004
Local Institution - 0026
Local Institution - 0010
Local Institution - 0006
Local Institution - 0036

intervention_type: Biological


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181 as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors

summary: This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.

design_allocation: Non-Randomized

ReferenceCitation: Lambert SL, Zhang C, Guo C, Turan T, Masica DL, Englert S, Fang Y, Sheridan J, McLaughlin RT, Tribouley C, Vosganian G, Afar D. Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab. J Immunother. 2022 Apr 1;45(3):167-179. doi: 10.1097/CJI.0000000000000408.

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Calvo E, Spira A, Miguel M, Kondo S, Gazzah A, Millward M, Prenen H, Rottey S, Warburton L, Alanko T, Cassier PA, Yoh K, Italiano A, Moreno V, Peltola K, Seto T, Toyozawa R, Afar DE, Englert S, Komarnitsky P, Lambert S, Parikh A, Vosganian G, Gao B. Safety, pharmacokinetics, and efficacy of budigalimab with rovalpituzumab tesirine in patients with small cell lung cancer. Cancer Treat Res Commun. 2021;28:100405. doi: 10.1016/j.ctarc.2021.100405. Epub 2021 May 25.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

ReferenceCitation: Italiano A, Cassier PA, Lin CC, Alanko T, Peltola KJ, Gazzah A, Shiah HS, Calvo E, Cervantes A, Roda D, Tosi D, Gao B, Millward M, Warburton L, Tanner M, Englert S, Lambert S, Parikh A, Afar DE, Vosganian G, Moreno V. First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2022 Feb;71(2):417-431. doi: 10.1007/s00262-021-02973-w. Epub 2021 Jul 3.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: University of Helsinki - Helda

repositories_concat: HELDA - Digital Repository of the University of Helsinki;PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Powderly J, Spira A, Kondo S, Doi T, Luke JJ, Rasco D, Gao B, Tanner M, Cassier PA, Gazzah A, Italiano A, Tosi D, Afar DE, Parikh A, Engelhardt B, Englert S, Lambert SL, Kasichayanula S, Mensing S, Menon R, Vosganian G, Tolcher A. Model Informed Dosing Regimen and Phase I Results of the Anti-PD-1 Antibody Budigalimab (ABBV-181). Clin Transl Sci. 2021 Jan;14(1):277-287. doi: 10.1111/cts.12855. Epub 2020 Dec 26.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: AbbVie

location_country:
Finland
Australia
Japan
Austria
Belgium
United States
Spain
Taiwan
Canada
France

location_facility: The University of Chicago Medical Center /ID# 157375

location_facility: National Cancer Center Hospital East /ID# 166433

location_facility: Hospital Universitario HM Sanchinarro /ID# 163861

location_facility: Virginia Cancer Specialists - Fairfax /ID# 157377

location_facility: Hospital Clinico Universitario de Valencia /ID# 163925

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 206229

location_facility: Medizinische Universitaet Graz /ID# 168752

location_facility: National Taiwan University Hospital /ID# 163997

location_facility: South Texas Accelerated Research Therapeutics /ID# 157378

location_facility: Taipei Medical University Hospital /ID# 163998

location_facility: Universitair Ziekenhuis Antwerpen /ID# 170702

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle /ID# 163999

location_facility: National Cancer Center Hospital /ID# 166279

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 163862

location_facility: Carolina BioOncology Institute /ID# 157376

location_facility: Moores Cancer Center at UC San Diego /ID# 157374

location_facility: St Vincent's Hospital Melbourne /ID# 167552


acronym: Viale-a

summary:
Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.

Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.

This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.

In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Pratz KW, Chai X, Xie J, Yin L, Nie X, Montez M, Iantuono E, Downs L, Ma E. Cost-Effectiveness Analysis of Venetoclax in Combination with Azacitidine Versus Azacitidine Monotherapy in Patients with Acute Myeloid Leukemia Who are Ineligible for Intensive Chemotherapy: From a US Third Party Payer Perspective. Pharmacoeconomics. 2022 Aug;40(8):777-790. doi: 10.1007/s40273-022-01145-7. Epub 2022 Jun 13.

ReferenceCitation: Konopleva M, Thirman MJ, Pratz KW, Garcia JS, Recher C, Pullarkat V, Kantarjian HM, DiNardo CD, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Wei AH. Impact of FLT3 Mutation on Outcomes after Venetoclax and Azacitidine for Patients with Treatment-Naive Acute Myeloid Leukemia. Clin Cancer Res. 2022 Jul 1;28(13):2744-2752. doi: 10.1158/1078-0432.CCR-21-3405.

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Pollyea DA, DiNardo CD, Arellano ML, Pigneux A, Fiedler W, Konopleva M, Rizzieri DA, Smith BD, Shinagawa A, Lemoli RM, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Kantarjian HM. Impact of Venetoclax and Azacitidine in Treatment-Naive Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. Clin Cancer Res. 2022 Jul 1;28(13):2753-2761. doi: 10.1158/1078-0432.CCR-21-3467.

ReferenceCitation: Pratz KW, Jonas BA, Pullarkat V, Recher C, Schuh AC, Thirman MJ, Garcia JS, DiNardo CD, Vorobyev V, Fracchiolla NS, Yeh SP, Jang JH, Ozcan M, Yamamoto K, Illes A, Zhou Y, Dail M, Chyla B, Potluri J, Dohner H. Measurable Residual Disease Response and Prognosis in Treatment-Naive Acute Myeloid Leukemia With Venetoclax and Azacitidine. J Clin Oncol. 2022 Mar 10;40(8):855-865. doi: 10.1200/JCO.21.01546. Epub 2021 Dec 15.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

location_facility: Saitama Medical University International Medical Center /ID# 167814

location_facility: National Taiwan University Hospital /ID# 153900

location_facility: Princess Margaret Cancer Centre /ID# 153651

location_facility: The Jikei University Daisan Hospital /ID# 168745

location_facility: Dana-Farber Cancer Institute /ID# 167009

location_facility: West China Hospital, Sichuan University /ID# 167492

location_facility: Ottawa Hospital Research Institute /ID# 153541

location_facility: Hospital de Clinicas de Porto Alegre /ID# 157779

location_facility: Massachusetts General Hospital /ID# 200752

location_facility: Universitaetsklinikum St. Poelten /ID# 167436

location_facility: Kuzbass Regional Clinical Hospital /ID# 157461

location_facility: Moscow State budget healthcare /ID# 155738

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389

location_facility: Duplicate_Konkuk University Medical Ctr /ID# 153973

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854

location_facility: VA Caribbean Healthcare System /ID# 160507

location_facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487

location_facility: Nanfang Hospital of Southern Medical University /ID# 170148

location_facility: National Hospital Organization Mito Medical Center /ID# 168219

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077

location_facility: Klinicki bolnicki centar Zagreb /ID# 153383

location_facility: Samara State Medical University /ID# 157462

location_facility: Ankara Universitesi Fakultesi /ID# 155200

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 153789

location_facility: Northwestern University Feinberg School of Medicine /ID# 201133

location_facility: The Second Hospital of Hebei Medical University /ID# 167316

location_facility: Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268

location_facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267

location_facility: Baylor Scott & White Medical Center- Temple /ID# 157191

location_facility: University of Texas MD Anderson Cancer Center /ID# 154100

location_facility: Medizinische Hochschule Hannover /ID# 153055

location_facility: Poltava Reg Clin Hosp Sklifoso /ID# 153513

location_facility: Helsinki University Hospital /ID# 155223

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493

location_facility: Sir Charles Gairdner Hospital /ID# 163924

location_facility: Assaf Harofeh Medical Center /ID# 158063

location_facility: Kyiv city clinical hospital #9 /ID# 153510

location_facility: Hospital Universitario de Navarra /ID# 153254

location_facility: Universitaetsklinikum Muenster /ID# 153059

location_facility: University of California, Los Angeles /ID# 154107

location_facility: Hospital Universitario 12 de Octubre /ID# 153258

location_facility: Hospital Santa Creu i Sant Pau /ID# 153193

location_facility: University of Fukui Hospital /ID# 167432

location_facility: Duplicate_Regional Oncology Dispensary /ID# 153264

location_facility: Tennessee Oncology-Nashville Centennial /ID# 200854

location_facility: University Of Vermont Medical /ID# 157196

location_facility: Sepctrum Health Medical Center /ID# 159522

location_facility: Hospital Clinic de Barcelona /ID# 153255

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315

location_facility: Hospital General Universitario Gregorio Maranon /ID# 153260

location_facility: Fakultni nemocnice Hradec Kralove /ID# 154021

location_facility: Duplicate_Kyoto Prefectural University of Medicine /ID# 167661

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 155136

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990

location_facility: Hospital Universitario y Politecnico La Fe /ID# 153259

location_facility: Emory Midtown Infectious Disease Clinic /ID# 162534

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 153814

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813

location_facility: Aichi Cancer Center Hospital /ID# 200824

location_facility: Qilu Hospital of Shandong University /ID# 167485

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875

location_facility: Hospital Universitario Virgen de la Victoria /ID# 153257

location_facility: Duplicate_Landeskrankenhaus Salzburg /ID# 169719

location_facility: Instituto de Ensino e Pesquisa São Lucas /ID# 157778

location_facility: Duplicate_Kindai University Hospital /ID# 167662

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877

location_facility: Ospedale Policlinico San Martino /ID# 158104

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882

location_facility: Juntendo University Hospital /ID# 168309

location_facility: Beth Israel Deaconess Medical Center /ID# 201155

location_facility: Universitaetsklinikum Halle (Saale) /ID# 153058

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 152881

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 154885

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095

location_facility: University of Chicago Medicine /ID# 154108

location_facility: Haukeland University Hospital /ID# 154281

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902

location_facility: St Vincent's Hospital Melbourne /ID# 155094

location_facility: Osaka Metropolitan University Hospital /ID# 169055

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 168316

location_facility: The Royal Melbourne Hospital /ID# 155095

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460

location_facility: Columbia Univ Medical Center /ID# 154101

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099

location_facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846

location_facility: China Medical University Hospital /ID# 153904

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883

location_facility: Ondokuz Mayis Universitesi Tip /ID# 155201

location_facility: Kyiv Regional Onco Dispensary /ID# 153514

location_facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876

location_facility: Universitaetsklinikum Frankfurt /ID# 153060

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385

location_facility: Karolinska University Hospital /ID# 170003

location_facility: Hacettepe University Faculty of Medicine /ID# 202073

location_facility: Hospital Universitario de la Princesa /ID# 153256

location_facility: Seoul National University Hospital /ID# 153675

location_facility: Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740

location_facility: Fujian Medical University Union Hospital /ID# 167314

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 201111

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 153684

location_facility: Duplicate_Semmelweis Egyetem /ID# 153815

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511

location_facility: Akershus universitetssykehus /ID# 154279

location_facility: Presidio Ospedaliero Vito Fazzi /ID# 170837

location_facility: The Chaim Sheba Medical Center /ID# 154173

location_facility: Nagasaki University Hospital /ID# 168632

location_facility: Yamagata University Hospital /ID# 167634

location_facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 153623

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639

location_facility: Medizinische Universitaet Graz /ID# 157882

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 162725

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317

location_facility: The First Hospital of Jilin University /ID# 167490

location_facility: Tel Aviv Sourasky Medical Center /ID# 154175

title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
France
Portugal
Hungary
Denmark
United States
Ukraine
Belgium
China
Puerto Rico
Italy
Norway
Sweden
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


acronym: ClarIDHy

lead_sponsor: Institut de Recherches Internationales Servier

summary: Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.

ReferenceCitation: Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021 Nov 1;7(11):1669-1677. doi: 10.1001/jamaoncol.2021.3836.

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Medical Association

ReferenceCitation: Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. doi: 10.1016/S1470-2045(20)30157-1. Epub 2020 May 13. Erratum In: Lancet Oncol. 2020 Oct;21(10):e462.

version: acceptedVersion

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
UCL Discovery
escholarship.org

repositories_institution: University College London - UCL Discovery

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Wisconsin, Carbone Cancer Center

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS Candiolo)

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: The Christie NHS Foundation Trust, the Christie Hospital

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

source: euctr

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

Access can be requested for all interventional clinical studies:

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

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

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

design_allocation: Randomized

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

ipd_sharing: Yes


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors

summary: This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

status: Active, not recruiting

study_completion_date_type: Anticipated

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

location_facility: Princess Margaret Cancer Centre /ID# 200819

location_facility: Tennessee Oncology-Nashville Centennial /ID# 158654

location_facility: Seoul National University Hospital /ID# 166291

location_facility: The University of Chicago Medical Center /ID# 155264

location_facility: Yonsei University Health System Severance Hospital /ID# 166292

location_facility: National Cancer Center Hospital East /ID# 216870

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129

location_facility: Hospital Universitario y Politecnico La Fe /ID# 200975

location_facility: University of Texas MD Anderson Cancer Center /ID# 155263

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 200128

location_facility: Duplicate_Institut Regional du Cancer /ID# 163609

location_facility: Hospital Universitario HM Sanchinarro /ID# 200127

location_facility: Virginia Cancer Specialists - Fairfax /ID# 155266

location_facility: Massachusetts General Hospital /ID# 155267

location_facility: The Angeles Clinic and Researc /ID# 156324

location_facility: National Cancer Center Hospital /ID# 217758

location_facility: Carolina BioOncology Institute /ID# 155265

status_simplified: Ongoing


title: A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

acronym: CheckMate 650

summary: The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).

ReferenceCitation: Sharma P, Pachynski RK, Narayan V, Flechon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

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

location_facility:
Local Institution - 0075
Local Institution - 0017
Local Institution - 0029
Local Institution - 0030
Local Institution - 0031
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Local Institution - 0066
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Local Institution - 0019
Local Institution - 0051
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042


title: A Randomized Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma (TAPPAS)

acronym: TAPPAS

summary: This is a study of TRC105 in combination with standard dose pazopanib compared to single agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g., metastatic or bulky disease, and disease for which surgical resection would carry an unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.

ReferenceCitation: Jones RL, Ravi V, Brohl AS, Chawla S, Ganjoo KN, Italiano A, Attia S, Burgess MA, Thornton K, Cranmer LD, Cheang MCU, Liu L, Robertson L, Adams B, Theuer C, Maki RG. Efficacy and Safety of TRC105 Plus Pazopanib vs Pazopanib Alone for Treatment of Patients With Advanced Angiosarcoma: A Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):740-747. doi: 10.1001/jamaoncol.2021.3547.

ReferenceCitation: Mehta CR, Liu L, Theuer C. An adaptive population enrichment phase III trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS trial). Ann Oncol. 2019 Jan 1;30(1):103-108. doi: 10.1093/annonc/mdy464.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

lead_sponsor: Tracon Pharmaceuticals Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Austria
United States
Spain
France

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Memorial Cancer Center and Institute of Oncology


title: 24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)

summary: The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Oldenburg J, Hay CRM, Jimenez-Yuste V, Peyvandi F, Schved JF, Szamosi J, Winding B, Lethagen S. Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study. BMJ Open. 2019 May 30;9(5):e028012. doi: 10.1136/bmjopen-2018-028012.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories:
PubMed Central
air.unimi.it
dnet

repositories_concat: PubMed Central;air.unimi.it;dnet

publisher_dissemination: British Medical Journal

ipd_sharing: Undecided

lead_sponsor: Swedish Orphan Biovitrum

sponsor_collaborators:
Swedish Orphan Biovitrum
ICON plc

location_country:
Finland
Italy
Norway
United Kingdom
Sweden
Austria
Belgium
Spain
France

location_facility:
Swedish Orphan Biovitrum Reserach site
Swedish Orphan Biovitrum research site
Swedish Orphan Biovitrum Research site
Swedish Orphan Biovitrum Research Site


acronym: ENGAGE

intervention_type: Other

lead_sponsor: Ipsen

summary: The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.

ReferenceCitation: Gracies JM, Francisco GE, Jech R, Khatkova S, Rios CD, Maisonobe P; ENGAGE Study Group. Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults With Spastic Paresis. J Neurol Phys Ther. 2021 Jul 1;45(3):203-213. doi: 10.1097/NPT.0000000000000359.

location_facility: Department of Neurology, Division of Movement Disorders, Vanderbilt University

location_facility: Federal Siberian Scientific Clinical Center

location_facility: Kansas Institute of Research, Kansas City Bone & Joint Clinic, Division of Signature Medical Group of KC

location_facility: Neurology and Physiotherapy Outpatient Clinic

location_facility: University of Pittsburgh Medical Center, Physical Medicine and Rehabilitation

location_facility: Service de Médecine Physique et Réadaptation, Hôpital Sébastopol - CHU de Reims

location_facility: Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital in Prague

location_facility: UT Health Physical Medicine & Rehabilitation Department, TIRR Memorial Hermann

location_facility: Saint-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: Fakultní nemocnice Brno Neurologická klinika

location_facility: Service de Médecine Physique et de Réadaptation, Bâtiment Tastet-Girard, Groupe Hospitalier Pellegrin

location_facility: Neurology Department - Regional Hospital Pardubice

location_facility: Fakultní nemocnice Královské Vinohrady, Neurologická klinika

location_facility: Service de Médecine Physique et Réadaptation, CHU Saint Etienne - Hôpital Bellevue

location_facility: Service de Médecine Physique et Réadaptation, Hôpital Albert-Chenevier

location_facility: Samara Regional Clinical Hospital n.a. V.D.Seredavin

title: An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
United States
Czechia
Russian Federation
France


title: Prospective, Multinational, Non-interventional Post-authorisation Study to Document the Long-term Immunogenicity, Safety, and Efficacy of Human-cl rhFVIII (Simoctocog Alfa) in Patients With Haemophilia A Treated in Routine Clinical Practice

summary: Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

lead_sponsor: Octapharma

location_country:
Belarus
Italy
Guatemala
Lithuania
Portugal
Slovakia
Ecuador
Argentina
Norway
United Kingdom
United States
Czechia
France

location_facility: A.O. Città della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: Nottingham University Hospitals NHS Trust

location_facility: AOU Federico II - Dipartimento di Medicina Clinica e Chirurgica

location_facility: Vilnius University Hospital, Santariskiu Klinikos-Children's Hospital

location_facility: Gulf States Hemophilia and Thrombophilia

location_facility: U.O.C. Ematologia, Ospedale San Giacomo Apostolo

location_facility: CTH Centro de Tratamiento de Hematologia y Hemoterapia Córdoba S.A.

location_facility: Dipartimento Di Medicina dell'Universita degli Studi di Perugia

location_facility: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

location_facility: L'Azienda Ospedaliero Universitaria Consorziale Policlinico, U.O. di Medicina Trasfusionale, Centro Emofilia e Trombosi

location_facility: Hospital de Especialidades Teodoro Maldonado Carbo

location_facility: Centro de Tratamiento de la Hemofilia Cordoba

location_facility: UOC Malattie emorragiche e della coagulazione, Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Sanitaria Locale Napoli 1 Centro

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia -"Sapienza" Università di Roma

location_facility: S.C. Ematologia U, A.O.U. Città della Salute e della Scienza di Torino


title: A Phase 1 Study of LY3200882 in Patients With Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

enrollment_type: Anticipated

ReferenceCitation: Yap TA, Vieito M, Baldini C, Sepulveda-Sanchez JM, Kondo S, Simonelli M, Cosman R, van der Westhuizen A, Atkinson V, Carpentier AF, Lohr M, Redman R, Mason W, Cervantes A, Le Rhun E, Ochsenreither S, Warren L, Zhao Y, Callies S, Estrem ST, Man M, Gandhi L, Avsar E, Melisi D. First-In-Human Phase I Study of a Next-Generation, Oral, TGFbeta Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer. Clin Cancer Res. 2021 Dec 15;27(24):6666-6676. doi: 10.1158/1078-0432.CCR-21-1504. Epub 2021 Sep 21.

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: LillOA (Lille Open Archive);PubMed Central

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Australia
Japan
Switzerland
United States
Spain
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Hospital Clínico Universitario de Valencia


acronym: VIGOR-ALS

lead_sponsor: Cytokinetics

summary: The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).

location_facility: University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School

location_facility: IRCCS Istituto Auxologico Italiano - U.O. Neurologia

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: Neurosciences Institute, Neurology - Charlotte

location_facility: Providence Brain and Spine Inst. ALS Center

location_facility: Charite Campus Virchow-Klinikum, Department of Neurology

location_facility: Hannover Medical School, Department of Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: Clinical Research Centre Beaumont Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"

location_facility: St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics

location_facility: QE II Health Sciences, Nova Scotia Health Authority

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hopital Dupuytren, service de neurologie

location_facility: University of Iowa Hospitals and Clinics

location_facility: George Washington University Medical Center

location_facility: Vanderbilt University Medical Center - Clinical Research Center

location_facility: St. Louis University, Department of Neurology & Psychiatry

location_facility: UTHSCSA - First Outpatient Research Unit

location_facility: University of Miami, Miller School of Medicine

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

location_facility: Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Department of Neurology, Wake Forest School of Medicine

location_facility: University of Ulm, Department of Neurology

location_facility: Hospital Santa Maria - Centro Hospitalar Lisboa Norte

title: A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
France


title: A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension

acronym: TOMORROW

summary: This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

status: Recruiting

lead_sponsor: Actelion

location_country:
Finland
Poland
Australia
Brazil
Thailand
Vietnam
Canada
France
Colombia
Portugal
Hungary
United States
Ukraine
China
Malaysia
Philippines
Austria
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel

location_facility: General Hospital of Shenyang Military Region

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Novosibirsk Research Institue of Blood Circulation Pathology n.a. E.N. Meshalkin

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

location_facility: GBUZ Children's Hospital named after Bashlyaeva Z.A. Moscow

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: The Children's Hospital, Zhejiang University school of Medicine

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Irmandade Da Santa Casa de Misericórdia de São Paulo

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: Municipal Institution of Health Care Regional Children's Clinical Hospital

location_facility: Research Institute of Complex Cardiovascular Pathology

location_facility: MI Dnipropetrovsk Specialized Clin. Med. Center of Mother and Child n.a. prof. M.F. Rudnev of DRC

location_facility: University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital

location_facility: Columbia University Medical Center - PIN

location_facility: Schneider Children's Medical Center of Israel - PIN

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: MI Scientific Practical Medical Center for Children Cardiology and Cardiosurgery of MOH of Ukraine

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Hôpital Haut-Lévêque - Hôpital cardiologique

location_facility: Saint Petersburg State Pediatric Medical Academy

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: Beijing Anzhen Hospital of The Capital University of Medical Sciences


acronym: Sequoia

summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.

ReferenceCitation: Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

sponsor_collaborators:
Eli Lilly and Company
ARMO BioSciences

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: New England Cancer Specialists - Scarborough

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: University of Massachusetts Medical Center

location_facility: Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

location_facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH

location_facility: Severance Hospital Yonsei University Health System

location_facility: North Shore Hematology Oncology Associates

location_facility: Novant Health, Oncology Research Institute

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB

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

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg

location_facility: Texas Oncology-Wichital Falls Texoma Cancer Center

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Chonnam National University Hwasun Hospital

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Toronto Sunnybrook Regional Cancer Center

location_facility: Central Coast Medical Oncology Corporation

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: University College London Hospital Foundation Trust

title: Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

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:
Germany
Italy
Poland
United Kingdom
Australia
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France


title: Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

summary: The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Italy
Singapore
Belgium
United States
Spain
Taiwan
Canada
Israel

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center SC-3


title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

summary: The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Hong Kong
Singapore
Japan
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Baylor Scott and White Research Institute


title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

summary: CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.

ReferenceCitation: Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: Celgene

location_country:
Norway
United Kingdom
United States
Spain
Canada
France

location_facility:
Hopital Lyon Sud
Local Institution - 700
Local Institution - 105
Local Institution - 101
Institut Claudius Regaud, IUCT-Oncopole
Local Institution - 602
Local Institution - 102
Local Institution - 605
Local Institution - 301
Local Institution - 604
Local Institution - 103
Local Institution - 601
Local Institution - 701
Local Institution - 600
Local Institution - 603
Local Institution - 104
Institut Paoli Calmettes
Local Institution - 201
Chru De Lille - Hopital Claude Huriez


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene

summary: This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.

status: Unknown status

lead_sponsor: Arog Pharmaceuticals, Inc.

sponsor_collaborators:
Arog Pharmaceuticals, Inc.
Centre Leon Berard
Fox Chase Cancer Center

location_country:
Germany
Italy
Poland
Norway
United States
Spain
France

location_facility: M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology

location_facility: Mannheim University Medical Centre, University of Heidelberg

location_facility: University Hospital The Norwegian Radium Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Reims

location_facility: Fundación Instituto Valenciano de Oncología

status_simplified: Unknown


acronym: DISCOVER

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.

ReferenceType: result

ReferenceCitation: Hare B. The Phase 3 DISCOVER Study: Daily F/TAF or F/TDF for HIV Preexposure Prophylaxis [Presentation]. Conference on Retroviruses and Opportunistic Infections (CROI); 2019 04-07 March; Seattle, WA.

ReferenceCitation: Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, DeJesus E, Jessen H, Grant RM, Ruane PJ, Wong P, Ebrahimi R, Zhong L, Mathias A, Callebaut C, Collins SE, Das M, McCallister S, Brainard DM, Brinson C, Clarke A, Coll P, Post FA, Hare CB. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020 Jul 25;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5.

ReferenceCitation: Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD; DISCOVER study team. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2021 Jul;8(7):e397-e407. doi: 10.1016/S2352-3018(21)00071-0. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.

repositories_concat: UCL Discovery

ReferenceCitation: Glidden DV, Das M, Dunn DT, Ebrahimi R, Zhao Y, Stirrup OT, Baeten JM, Anderson PL. Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial. J Int AIDS Soc. 2021 May;24(5):e25744. doi: 10.1002/jia2.25744.

repositories_institution: University of California - eScholarship University of California

title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Netherlands
Austria
United States
Spain
Canada
France


title: Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome

summary: Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).

ReferenceCitation: Pane F, Lefevre G, Kwon N, Bentley JH, Yancey SW, Steinfeld J. Characterization of disease flares and impact of mepolizumab in patients with hypereosinophilic syndrome. Front Immunol. 2022 Aug 26;13:935996. doi: 10.3389/fimmu.2022.935996. eCollection 2022.

publisher_dissemination: Frontiers

ReferenceCitation: Rothenberg ME, Roufosse F, Faguer S, Gleich GJ, Steinfeld J, Yancey SW, Mavropoulou E, Kwon N; HES Mepolizumab Study Group. Mepolizumab Reduces Hypereosinophilic Syndrome Flares Irrespective of Blood Eosinophil Count and Interleukin-5. J Allergy Clin Immunol Pract. 2022 Sep;10(9):2367-2374.e3. doi: 10.1016/j.jaip.2022.04.037. Epub 2022 May 12.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

ReferenceCitation: Reiter A, Lefevre G, Cid MC, Kwon N, Mavropolou E, Yancey SW, Steinfeld J. Association Between Baseline Therapy and Flare Reduction in Mepolizumab-Treated Patients With Hypereosinophilic Syndrome. Front Immunol. 2022 Apr 13;13:840974. doi: 10.3389/fimmu.2022.840974. eCollection 2022.

ReferenceCitation: Gleich GJ, Roufosse F, Chupp G, Faguer S, Walz B, Reiter A, Yancey SW, Bentley JH, Steinfeld J; HES Mepolizumab Study Group. Safety and Efficacy of Mepolizumab in Hypereosinophilic Syndrome: An Open-Label Extension Study. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4431-4440.e1. doi: 10.1016/j.jaip.2021.07.050. Epub 2021 Aug 10.

ReferenceCitation: Roufosse F, Kahn JE, Rothenberg ME, Wardlaw AJ, Klion AD, Kirby SY, Gilson MJ, Bentley JH, Bradford ES, Yancey SW, Steinfeld J, Gleich GJ; HES Mepolizumab study group. Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Dec;146(6):1397-1405. doi: 10.1016/j.jaci.2020.08.037. Epub 2020 Sep 18.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

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

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Brazil
Mexico
Belgium
United States
Spain
Russian Federation
France


title: An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.

lead_sponsor: H3 Biomedicine Inc.

sponsor_collaborators:
H3 Biomedicine Inc.
Eisai Inc.

location_country:
Italy
United Kingdom
Singapore
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France

location_facility: IRCCS Ospedale San Raffaele S.r.l. - PPDS

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Azienda Ospedaliero Universitaria - Policlinico di Modena

location_facility: Georgetown Unversity Lombardi Comprehensive Cancer Center

location_facility: START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Cincinnati Cancer Institute

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica

location_facility: John theurer Cancer Center at Hackensack University Medical Center

location_facility: University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine

location_facility: Sarah Cannon Research Institute UK - SCRI - PPDS

location_facility: University of Texas Southwestern Medical Center


title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).

summary: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

ReferenceType: background

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Giladi M, Weinberg U, Schneiderman RS, Porat Y, Munster M, Voloshin T, Blatt R, Cahal S, Itzhaki A, Onn A, Kirson ED, Palti Y. Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo. Semin Oncol. 2014 Oct;41 Suppl 6:S35-41. doi: 10.1053/j.seminoncol.2014.09.006. Epub 2014 Sep 8.

ReferenceCitation: Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

repository_institution: Université de Lausanne - SERVAL

ReferenceCitation: Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

ReferenceCitation: Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.

ReferenceCitation: Brozova H, Lucas A, Salmaggi A, Vymazal J. COMET: A phase II randomized study of TTFields versus supportive care in non-small cell lung cancer patients with 1-5 brain metastases - initial safety results. Neuro Oncol. 2015 Nov; 17 (suppl 5): v46. doi:10.1093/neuonc/nov208.6

lead_sponsor: NovoCure GmbH

location_country:
Germany
Italy
Poland
Hungary
Hong Kong
Israel
Austria
United States
China
Spain
Croatia
Bulgaria
Canada
Serbia
France

location_facility: The Second Affiliated Hospital Of Xingtai Medical College

location_facility: Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum

location_facility: Dr. Senckenbergisches Institut for Neurooncology,

location_facility: National Koranyi Institute of Tb and Pulmonology

location_facility: The IRCCS Carlo Besta Neurological Institute Foundation

location_facility: Heidelberg University Clinic for Radiooncology and Radiation Therapy

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: University Hospital of Messina AOU Policlinico "G. Martino"

location_facility: UNC - Lineberger Comprehensive Cancer Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: John Nasseff Neuroscience Institute ANW Brain Tumor Center

location_facility: The First Hospital of China Medical University

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University

location_facility: The First Affiliated Hospital of Soochow University

location_facility: First Affiliated Hospital of Xi'an Jiaotong University

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

location_facility: St. Mary's Medical Center - Grand Junction

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Azienda Socio Sanitaria Territoriale di Lecco

location_facility: Walter Reed National Military Medical Center

location_facility: Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont

location_facility: Abbott Northwestern Hospital - Givens Brain Tumor Center

location_facility: Grandview Medical Center - Cancer Center

location_facility: Mischer Neuroscience Associates - Texas Medical Center

location_facility: Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie

location_facility: Onkologiai Osztaly, Balassa Janos Korhaz

location_facility: Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia

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

location_facility: Memorial Health University Medical Center

location_facility: University of Louisville-James Graham Brown Cancer Center

location_facility: A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie

location_facility: Banner North Colorado Medical Center (NCMC) - Oncology - Greeley

location_facility: University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology

location_facility: Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Hospital Universitario HM Sanchinarro Edificio CIOCC

location_facility: Ellis Fischel Cancer Center, University of Missouri Healthcare

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology

location_facility: (CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

location_facility: Banner MD Anderson Cancer Center - McKee Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Marek Harat Private Practice, Neurosurgery and Radiation Oncology

location_facility: Medical University of South Carolina- Hollings Cancer Center

intervention_type: Device


acronym: ASCLEPIOS I

summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

ReferenceCitation: Gartner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Haring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

publisher_dissemination: SAGE Publications

ReferenceCitation: Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Haring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.

publisher_dissemination: Massachusetts Medical Society

title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

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

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

location_country:
Germany
Poland
Argentina
Australia
Thailand
Turkey
Croatia
Czechia
Canada
France
Slovakia
Hungary
Denmark
Switzerland
United States
India
Belgium
Estonia
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel


type: Registry Identifier

title: A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

acronym: EARNEST

summary: The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.

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.

lead_sponsor: Takeda

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

location_facility: University of Utah Health Sciences Center

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Charite Universitatsmedizin Berlin -Campus Virchow Klinikum


title: A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)

acronym: EFFECT

summary:
The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.

time_perspective: Retrospective

ReferenceCitation: Min J, Cohan S, Alvarez E, Sloane J, Phillips JT, van der Walt A, Koulinska I, Fang F, Miller C, Chan A. Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes. Neurol Ther. 2019 Jun;8(1):109-119. doi: 10.1007/s40120-019-0127-2. Epub 2019 Jan 31.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;boris.unibe.ch

lead_sponsor: Biogen

location_country:
France
Germany
Italy
Hungary
Argentina
United Kingdom
Australia
Switzerland
United States
Spain
Croatia
Canada
Czech Republic


title: A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

summary: This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and DARA for Newly Diagnosed Multiple Myeloma (NDMM).

ReferenceCitation: Lonial S, Popat R, Hulin C, Jagannath S, Oriol A, Richardson PG, Facon T, Weisel K, Larsen JT, Minnema MC, Abdallah AO, Badros AZ, Knop S, Stadtmauer EA, Cheng Y, Amatangelo M, Chen M, Nguyen TV, Amin A, Peluso T, van de Donk NWCJ. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lancet Haematol. 2022 Nov;9(11):e822-e832. doi: 10.1016/S2352-3026(22)00290-3. Epub 2022 Oct 6.

oa_host_type: closed

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Japan
Netherlands
United States
Spain
Canada
France

location_facility:
Local Institution - 204
Local Institution - 811
Local Institution - 407
Local Institution - 112
Local Institution - 101
Local Institution - 802
Local Institution - 102
Local Institution - 205
Local Institution - 137
Local Institution - 604
Local Institution - 305
Local Institution - 601
Local Institution - 134
Local Institution - 701
Local Institution - 703
Local Institution - 140
Local Institution - 139
Local Institution - 801
Local Institution - 114
Local Institution - 804
Local Institution - 502
Local Institution - 113
Local Institution - 402
Local Institution - 754
Local Institution - 117
Local Institution - 125
Local Institution - 408
Local Institution - 126
Local Institution - 109
Local Institution - 809
Local Institution - 202
Local Institution - 307
Local Institution - 104
Local Institution - 814
Local Institution - 203
Local Institution - 111
Local Institution - 116
Local Institution - 302
Local Institution - 107
Local Institution - 751
Local Institution - 803
Local Institution - 503
Local Institution - 901
Local Institution - 755
Local Institution - 108
Local Institution - 124
Local Institution - 903
Local Institution - 301
Local Institution - 405
Local Institution - 606
Local Institution - 122
Local Institution - 902
Local Institution - 805
Local Institution - 504
Local Institution - 702
Local Institution - 404
Local Institution - 303
Local Institution - 704
Local Institution - 201
Local Institution - 813
Local Institution - 132
Local Institution - 118
Local Institution - 756
Local Institution - 121
Local Institution - 138
Local Institution - 106
Local Institution - 110
Local Institution - 904
Local Institution - 812
Local Institution - 808
Local Institution - 602
Local Institution - 501
Local Institution - 123
Local Institution - 605
Local Institution - 141
Local Institution - 131
Local Institution - 115
Local Institution - 103
Local Institution - 119
Local Institution - 603
Local Institution - 401
Local Institution - 852
Local Institution - 806
Local Institution - 120
Local Institution - 815
Local Institution - 406
Local Institution - 810
Local Institution - 854
Local Institution - 807


lead_sponsor: Hoffmann-La Roche

summary: This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

ReferenceCitation: Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.

ReferenceCitation: Mansfield AS, Kazarnowicz A, Karaseva N, Sanchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.

ReferenceCitation: Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.

ReferenceCitation: Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

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

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Hopital Calmette; Pneumologie Oncologie Ouest

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: National Hospital Organization Himeji Medical Center

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

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Cancer Treatment Centers of America - Midwestern Regional Medical Center

location_facility: Kanagawa Cancer Center;Thoracic Oncology

location_facility: University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine

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

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

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: University Hospital of Patras Medical Oncology

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

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Clinical Center Nis; Clinic for pulmonary diseases

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Seoul National University Bundang Hospital

location_facility: Kurashiki Central Hospital; Respiratory Medicine

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

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

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

title: A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

location_country:
Germany
Poland
Australia
Brazil
Japan
Chile
Czechia
Serbia
France
Hungary
United States
China
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation


title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

summary: The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Australia
Netherlands
United States
Canada
France

location_facility:
Local Institution - 0017
Local Institution - 0018
Local Institution - 0003
Local Institution - 0021
Local Institution - 0009
Local Institution - 0015
Local Institution - 0007
Local Institution - 0002
Local Institution - 0024
Local Institution - 0028
Local Institution - 0005
Local Institution - 0014
Local Institution - 0012
Local Institution - 0016
Local Institution - 0020
Local Institution - 0023
Local Institution - 0001
Local Institution - 0022
Local Institution - 0033
Local Institution - 0008
Local Institution - 0013
Local Institution - 0004
Local Institution - 0019
Local Institution - 0006


title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer

summary: The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

ReferenceCitation: Jin T, Xu L, Wang P, Hu X, Zhang R, Wu Z, Du W, Kan W, Li K, Wang C, Zhou Y, Li J, Liu T. Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)picolinonitrile. J Med Chem. 2021 Oct 28;64(20):15069-15090. doi: 10.1021/acs.jmedchem.1c00994. Epub 2021 Oct 19.

publisher_dissemination: American Chemical Society

location_country:
Germany
United Kingdom
Netherlands
United States
Korea, Republic of
Spain
Greece
Turkey
Ukraine
France

location_facility: Florida Cancer Specialists and Research Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."

location_facility: The Center for Cancer and Blood Disorders

location_facility: Chattanooga Oncology Hematology Associates

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.


title: A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors

summary: GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

ReferenceCitation: Turner DC, Wada R, Zhou H, Wang X, de Greef R, Valiathan C, Zhang L, Zhang N, Kuchimanchi M, Chen TT, Ballas M, Visser SAG. Model-based meta-analysis of non-small cell lung cancer with standard of care PD-1 inhibitors and chemotherapy for early development decision making. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1751-1763. doi: 10.1002/psp4.12917. Epub 2023 Jan 31.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Merck Sharp & Dohme LLC

location_country:
Italy
Australia
Japan
Netherlands
United States
China
Spain
Canada
France


lead_sponsor: Parion Sciences

summary: The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi

sponsor_collaborators:
Parion Sciences
Vertex Pharmaceuticals Incorporated

title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi

location_country:
United States
Ireland
United Kingdom
France