acronym: NATIVE

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

lead_sponsor: Inventiva Pharma

ReferenceCitation: Francque SM, Bedossa P, Ratziu V, Anstee QM, Bugianesi E, Sanyal AJ, Loomba R, Harrison SA, Balabanska R, Mateva L, Lanthier N, Alkhouri N, Moreno C, Schattenberg JM, Stefanova-Petrova D, Vonghia L, Rouzier R, Guillaume M, Hodge A, Romero-Gómez M, Huot-Marchand P, Baudin M, Richard MP, Abitbol JL, Broqua P, Junien JL, Abdelmalek MF; NATIVE Study Group. A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. N Engl J Med. 2021 Oct 21;385(17):1547-1558. doi: 10.1056/NEJMoa2036205.

ReferenceCitation: Sven M F, Pierre B, Manal F A, Quentin M A, Elisabetta B, Vlad R, Philippe HM, Bruno S, Jean-Louis J, Pierre B, Jean-Louis A. A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study. Contemp Clin Trials. 2020 Nov;98:106170. doi: 10.1016/j.cct.2020.106170. Epub 2020 Oct 8.

location_country:
Poland
Slovenia
Italy
Austria
Australia
Spain
Canada
United Kingdom
Switzerland
United States
France
Mauritius
Belgium
Germany
Bulgaria
Czechia

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: University of Western Ontario, London Health Sciences Centre

location_facility: Innere Medizin II - Universitätsklinik Freiburg

location_facility: Lyell McEwin Hospital & The University of Adelaide

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hôpital Purpan - Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: Ospedali Riuniti di Ancona-Università Politecnica delle Marche

location_facility: Granda Ospedale Maggiore Policlinico - Università di Milano

location_facility: Universitätsmedizin Mainz, I. Med. Klinik

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

location_facility: Katedra i Klinika Chorób Zakaźnych i Hepatologii Uniwersytetu Medycznego w Łodzi

location_facility: Virgen de la Victoria University Hospital

location_facility: Institut klinické a experimentální medicíny, IKEM

location_facility: Flinders Medical Centre Department of Hepatology

location_facility: Oddzial Gastroenterologii Hepatologii UCK

location_facility: Florida Digestive Health Specialists, LLP

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin

location_facility: Centre Hospitalier Universitaire de Rennes

summary:
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need.

IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic.

The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.


type: Other Identifier

title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

summary: The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Coleman M, Belada D, Casasnovas RO, Gressin R, Lee HP, Mehta A, Munoz J, Verhoef G, Corrado C, DeMarini DJ, Zhao W, Li J, Fay K. Phase 2 study of parsaclisib (INCB050465), a highly selective, next-generation PI3Kδ inhibitor, in relapsed or refractory diffuse large B-cell lymphoma (CITADEL-202). Leuk Lymphoma. 2021 Feb;62(2):368-376. doi: 10.1080/10428194.2020.1832660. Epub 2020 Nov 3.

lead_sponsor: Incyte Corporation

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

location_facility: Chu de Grenoble - Hopital Albert Michallon

location_facility: Advocate Medical Group Niles Milwaukee Ave

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: CHU de Grenoble - Hôpital Albert Michallon

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Nuestra Señora de Valme

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to "Standard of Care" Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension

acronym: REGAIN CONTROL

summary:
Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change

Secondary Objectives:

To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change.
To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group).
Change in fasting plasma glucose (FPG).
Change in body weight.
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc).
Change in hypoglycemic control subscale (HCS).
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

design_allocation: Randomized

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

ReferenceCitation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyên-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

ipd_sharing: Yes

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

lead_sponsor: Sanofi

location_country:
Brazil
Spain
Ireland
Greece
Italy
United Kingdom
Finland
Switzerland
France
Romania

location_facility:
Investigational Site Number 246007
Investigational Site Number 372002
Investigational Site Number 826021
Investigational Site Number 380015
Investigational Site Number 380012
Investigational Site Number 724022
Investigational Site Number 724016
Investigational Site Number 756002
Investigational Site Number 826033
Investigational Site Number 642003
Investigational Site Number 250026
Investigational Site Number 724005
Investigational Site Number 380033
Investigational Site Number 826024
Investigational Site Number 076004
Investigational Site Number 380023
Investigational Site Number 724003
Investigational Site Number 724009
Investigational Site Number 380007
Investigational Site Number 724004
Investigational Site Number 076009
Investigational Site Number 380031
Investigational Site Number 642001
Investigational Site Number 724008
Investigational Site Number 724012
Investigational Site Number 724013
Investigational Site Number 724017
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 724027
Investigational Site Number 380026
Investigational Site Number 250003
Investigational Site Number 380014
Investigational Site Number 724020
Investigational Site Number 756003
Investigational Site Number 826007
Investigational Site Number 246008
Investigational Site Number 380036
Investigational Site Number 380018
Investigational Site Number 826002
Investigational Site Number 076-003
Investigational Site Number 826019
Investigational Site Number 826037
Investigational Site Number 642004
Investigational Site Number 380020
Investigational Site Number 724010
Investigational Site Number 246001
Investigational Site Number 246009
Investigational Site Number 826025
Investigational Site Number 826004
Investigational Site Number 724019
Investigational Site Number 826023
Investigational Site Number 724014
Investigational Site Number 724028
Investigational Site Number 724021
Investigational Site Number 826017
Investigational Site Number 826006
Investigational Site Number 372003
Investigational Site Number 380011
Investigational Site Number 246002
Investigational Site Number 380006
Investigational Site Number 250008
Investigational Site Number 826020
Investigational Site Number 250020
Investigational Site Number 380021
Investigational Site Number 724025
Investigational Site Number 642007
Investigational Site Number 724024
Investigational Site Number 826013
Investigational Site Number 076006
Investigational Site Number 724011
Investigational Site Number 380016
Investigational Site Number 642005
Investigational Site Number 642002
Investigational Site Number 250011
Investigational Site Number 076005
Investigational Site Number 724006
Investigational Site Number 380004
Investigational Site Number 250025
Investigational Site Number 724018
Investigational Site Number 642006
Investigational Site Number 076011
Investigational Site Number 826039
Investigational Site Number 380013
Investigational Site Number 076010
Investigational Site Number 826008
Investigational Site Number 724029
Investigational Site Number 380032
Investigational Site Number 724030
Investigational Site Number 724007
Investigational Site Number 250009
Investigational Site Number 250010
Investigational Site Number 380002
Investigational Site Number 826016
Investigational Site Number 300003
Investigational Site Number 724023
Investigational Site Number 250014
Investigational Site Number 380017
Investigational Site Number 380001
Investigational Site Number 300002
Investigational Site Number 642008
Investigational Site Number 076-001
Investigational Site Number 250002
Investigational Site Number 826009
Investigational Site Number 826031
Investigational Site Number 246004
Investigational Site Number 076008
Investigational Site Number 724002
Investigational Site Number 826035
Investigational Site Number 826018
Investigational Site Number 724001
Investigational Site Number 380024
Investigational Site Number 300004
Investigational Site Number 250013
Investigational Site Number 300001
Investigational Site Number 250015
Investigational Site Number 826038
Investigational Site Number 380025


status: Active, not recruiting

title: A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

study_completion_date_type: Anticipated

lead_sponsor: Astellas Pharma Global Development, Inc.

source: euctr

ReferenceCitation: Wang ES, Montesinos P, Minden MD, Lee JH, Heuser M, Naoe T, Chou WC, Laribi K, Esteve J, Altman JK, Havelange V, Watson AM, Gambacorti-Passerini C, Patkowska E, Liu S, Wu R, Philipose N, Hill JE, Gill SC, Rich ES, Tiu RV. Phase 3 trial of gilteritinib plus azacitidine vs azacitidine for newly diagnosed FLT3mut+ AML ineligible for intensive chemotherapy. Blood. 2022 Oct 27;140(17):1845-1857. doi: 10.1182/blood.2021014586.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

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

location_facility: Hematology-Oncology Associates of Northern NJ

location_facility: St. Louis University Cancer Center - Hematology/Oncology

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Robert H. Lurie Comprehensive Cancer Center

location_facility: University of California, Irvine Medical Center

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

summary:
This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.

For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster.

This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

status_simplified: Ongoing


title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

lead_sponsor: Gilead Sciences

ReferenceCitation: Bourlière M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Lédinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SI, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-1 and POLARIS-4 Investigators. Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi: 10.1056/NEJMoa1613512.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.

location_country:
United Kingdom
Australia
New Zealand
Canada
Puerto Rico
United States
France
Germany

summary: The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.


title: A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

summary: Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Sun Pharma Advanced Research Company Limited

location_country:
Romania
Spain
Italy
United Kingdom
Hungary
Korea, Republic of
India
United States
France
Belgium
Singapore

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

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

location_facility: Board of Regents of the University System of Georgia

location_facility: ICO Girona - Hospital Universitari de Girona Dr Josep Trueta

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Ferrarotto Alessi)

location_facility: Huntsman Cancer Institute University of Utah

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Uijeongbu Eulji Medical Center, Eulji University

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Memorial Sloan Kettering Cancer Center - MAIN

location_facility: CHU de Nancy - Hôpital de Brabois Adultes

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute


intervention_type: Other

acronym: Avelumab in First-Line Gastric Cancer

title: A Phase III Open-label, Multicenter Trial of Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy in Subjects With Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro-esophageal Junction

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. Review.

ReferenceCitation: Moehler M, Dvorkin M, Boku N, Özgüroğlu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coşkun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16.

location_country:
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Thailand
Hungary
Korea, Republic of
United States
France
Turkey
Romania
Japan
Germany

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Chonnam National University Hwasun Hospital

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Oncosinos - Clínica de Oncologia - Hospital Regina

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Adana Numune Training and Research Hospital

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

location_facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Seconda Università degli Studi di Napoli

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

location_facility: Konya Necmettin Erbakan University Meram Medical Faculty

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

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

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Kyungpook National University Medical Center

location_facility: Trio - Central Coast Medical Oncology Corporation

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

location_facility: McGill University - Dept. Oncology Clinical Research Program

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Greenville Hospital System University Medical Center (ITOR)

location_facility: SBIH " Clinical Oncological Dispensary # 1"

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: IMV - Instituto De Medicina Vascular Hospital Mae de Deus

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary"

location_facility: Franciscan St. Francis Health Cancer Center

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital de Câncer de Barretos-Fundação Pio XII

location_facility: University of Kansas Medical Center Research Institute, Inc.

summary: The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.


title: Secondary Prevention of Cardiovascular Disease in the Elderly Trial

acronym: SECURE

summary: The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

primary_purpose: Prevention

ReferenceCitation: Castellano JM, Pocock SJ, Bhatt DL, Quesada AJ, Owen R, Fernandez-Ortiz A, Sanchez PL, Marin Ortuño F, Vazquez Rodriguez JM, Domingo-Fernández A, Lozano I, Roncaglioni MC, Baviera M, Foresta A, Ojeda-Fernandez L, Colivicchi F, Di Fusco SA, Doehner W, Meyer A, Schiele F, Ecarnot F, Linhart A, Lubanda JC, Barczi G, Merkely B, Ponikowski P, Kasprzak M, Fernandez Alvira JM, Andres V, Bueno H, Collier T, Van de Werf F, Perel P, Rodriguez-Manero M, Alonso Garcia A, Proietti M, Schoos MM, Simon T, Fernandez Ferro J, Lopez N, Beghi E, Bejot Y, Vivas D, Cordero A, Ibañez B, Fuster V; SECURE Investigators. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022 Sep 15;387(11):967-977. doi: 10.1056/NEJMoa2208275. Epub 2022 Aug 26.

ReferenceCitation: Buttgereit T, Palmowski A, Forsat N, Boers M, Witham MD, Rodondi N, Moutzouri E, Navidad AJQ, Van't Hof AWJ, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, da Silva J, Stegemann S, Bijlsma JW, Koeller M, Mooijaart S, Kearney PM, Buttgereit F. Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials. Age Ageing. 2021 Nov 10;50(6):1988-1996. doi: 10.1093/ageing/afab147.

lead_sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

location_country: Poland Spain Italy Hungary France Germany Czechia

location_facility: Klinik am See, Rehabilitationszentrum für innere Medizin

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: ASST Della Valle Olona-Ospedale di Saronno

location_facility: Ospedale Ss Giovanni di Dio e Ruggi d'Aragona

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

location_facility: Mediclin Reha-Zentrum Spreewald Fachklinik für innere Medizin

location_facility: Brandenburgklinik Berlin-Brandenburg GmbH, Haus Brandenburg/ Kardiologie

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: ASST Santi Paolo e Carlo-Ospedale San Paolo-Polo Univ.

location_facility: IRCCS Fondazione S. Maugeri Istit. di Cassano Murge

location_facility: Presidio Ospedaliero San Filippo Neri-ASL Roma E

location_facility: Gesundheitszentrum Bitterfeld /Wolfen GmbH

location_facility: ASST di Bergamo Ovest-Ospedale di Treviglio

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Principe de Asturias

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Régional et Universitaire de Lille

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Hospital Universitario Reina Sofia de Cordoba

location_facility: Ospedale Bolognini di Seriate - ASST BERGAMO EST

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: AAS3 "Alto Friuli, Collinare, Medio Friuli" Ospedale di San Daniele del Friuli-Tolmezzo sede di S. D. del Friuli

location_facility: Hospital General Universitario de Alicante

location_facility: Centrum Kardiologiczne "Pro Corde" Sp. z o.o.

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Charité - Universitätsmedizin Berlin, Centrum für Schlaganfallforschung (CSB)

location_facility: Specjalistyczny Szpital im. Dra Alfreda Sokołowskiego

location_facility: Szpital Wielospecjalistyczny im. Dr. Ludwika Błażka w Inowrocławiu

location_facility: Hospital Universitario QuironSalud Madrid

location_facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej w Świdnicy

location_facility: ASST Di Monza-Presidio Ospedaliero di Desio

location_facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Ospedale Generale di Zona-Ospedale Valduce

location_facility: ASL FG Ospedale "Teresa Masselli Mascia"

location_facility: Centre hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Hospital Clinic Universitari de Valencia

location_facility: Fejér Megyei Szent György Egyetemi Kórház

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7, Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca


title: A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

acronym: IDHENTIFY

summary: This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.

lead_sponsor: Celgene

location_country:
Denmark
Taiwan
Brazil
Spain
Italy
Austria
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
United States
France
China
Turkey
Belgium
Germany
Czechia

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: John Radcliffe Hospital The Oxford Radcliffe Hospital Clinical Haematology

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: University of Miami Sylvester Cancer Research Center

location_facility: Montefiore Medical Center Albert Einstein Cancer Center

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: The Third Xiangya hospital of central south university

location_facility: Fujian Medical University Union Hospital

location_facility: Hwasun Chonnam National University Hospital

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Hematology Dept Azienda Ospedaliero Universitaria Careggi

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

location_facility: MD Anderson Cancer Center The University of Texas

location_facility: Queens Centre for Oncology & Haematology

location_facility: Copenhagen University Hospital Rigshosptalet

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University Hospitals Cleveland Medical Center

location_facility: UCLA School of Medicine Hematology Oncology

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: The First Hospital of China Medical University

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Northshore University Healthsystem Research Institute

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

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

location_facility: Hospital Universitario Central de Asturias

location_facility: Peter MacCallum Cancer Centre - East Melbourne

location_facility: Shands Cancer Center University of Florida

location_facility: Medizinische Hochschule HannoverZentrum Innere Medizin

location_facility: University of Southern California Norris Cancer Center


title: A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

acronym: dal-GenE

summary: A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

ReferenceCitation: Tardif JC, Pfeffer MA, Kouz S, Koenig W, Maggioni AP, McMurray JJV, Mooser V, Waters DD, Grégoire JC, L'Allier PL, Wouter Jukema J, White HD, Heinonen T, Black DM, Laghrissi-Thode F, Levesque S, Guertin MC, Dubé MP; dal-GenE Investigators. Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial. Eur Heart J. 2022 Oct 14;43(39):3947-3956. doi: 10.1093/eurheartj/ehac374. Erratum in: Eur Heart J. 2022 Sep 20;:.

ReferenceCitation: Black DM, Miller M, Heinonen TM, Zhang G. Advancing Beyond Failed High-density Lipoprotein Clinical Trials to Pharmacogenetic Studies of ADCY9 and Cholesterol Ester Transfer Protein Inhibition. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):496-500. doi: 10.1097/FJC.0000000000001093. Review.

ReferenceCitation: Tardif JC, Dubé MP, Pfeffer MA, Waters DD, Koenig W, Maggioni AP, McMurray JJV, Mooser V, White HD, Heinonen T, Black DM, Guertin MC; dal-GenE Investigators. Study design of Dal-GenE, a pharmacogenetic trial targeting reduction of cardiovascular events with dalcetrapib. Am Heart J. 2020 Apr;222:157-165. doi: 10.1016/j.ahj.2020.01.007. Epub 2020 Jan 17.

lead_sponsor: DalCor Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
New Zealand
Finland
France
Chile
Netherlands
United Arab Emirates

location_facility:
Institut de Cardiologie de Montreal
Research Site


acronym: CONFIDENCE

title: CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

ReferenceCitation: Cutter G, Veneziano A, Grinspan A, Al-Banna M, Boyko A, Zakharova M, Maida E, Pasic MB, Gandhi SK, Everts R, Cordioli C, Rossi S. Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS. Mult Scler Relat Disord. 2019 Aug;33:13-21. doi: 10.1016/j.msard.2019.04.036. Epub 2019 May 9.

location_country:
Croatia
Poland
Spain
Ireland
Austria
Italy
Mexico
Argentina
Finland
Russian Federation
Puerto Rico
United States
France
Turkey
Belgium
Germany

location_facility:
Teva Investigational Site 35206
Teva Investigational Site 35211
Teva Investigational Site 20062
Teva Investigational Site 82052
Teva Investigational Site 37063
Teva Investigational Site 30164
Teva Investigational Site 35209
Teva Investigational Site 50374
Teva Investigational Site 50392
Teva Investigational Site 13470
Teva Investigational Site 35202
Teva Investigational Site 50373
Teva Investigational Site 53347
Teva Investigational Site 50389
Teva Investigational Site 32603
Teva Investigational Site 82051
Teva Investigational Site 31184
Teva Investigational Site 53349
Teva Investigational Site 35208
Teva Investigational Site 53348
Teva Investigational Site 53345
Teva Investigational Site 53355
Teva Investigational Site 35213
Teva Investigational Site 13472
Teva Investigational Site 37066
Teva Investigational Site 40015
Teva Investigational Site 32604
Teva Investigational Site 30163
Teva Investigational Site 13476
Teva Investigational Site 13479
Teva Investigational Site 13478
Teva Investigational Site 31182
Teva Investigational Site 30167
Teva Investigational Site 50377
Teva Investigational Site 44029
Teva Investigational Site 40014
Teva Investigational Site 31177
Teva Investigational Site 32602
Teva Investigational Site 35203
Teva Investigational Site 21095
Teva Investigational Site 35212
Teva Investigational Site 13524
Teva Investigational Site 50387
Teva Investigational Site 53354
Teva Investigational Site 21098
Teva Investigational Site 13482
Teva Investigational Site 60036
Teva Investigational Site 31181
Teva Investigational Site 30161
Teva Investigational Site 35210
Teva Investigational Site 21096
Teva Investigational Site 30166
Teva Investigational Site 20063
Teva Investigational Site 21097
Teva Investigational Site 50372
Teva Investigational Site 82050
Teva Investigational Site 35205
Teva Investigational Site 30169
Teva Investigational Site 53356
Teva Investigational Site 50375
Teva Investigational Site 35204
Teva Investigational Site 13475
Teva Investigational Site 13480
Teva Investigational Site 30162
Teva Investigational Site 60035
Teva Investigational Site 50390
Teva Investigational Site 35207
Teva Investigational Site 31178
Teva Investigational Site 13487
Teva Investigational Site 82049
Teva Investigational Site 13477
Teva Investigational Site 20061
Teva Investigational Site 60039
Teva Investigational Site 60037
Teva Investigational Site 53353
Teva Investigational Site 30165
Teva Investigational Site 13473
Teva Investigational Site 60034
Teva Investigational Site 50376
Teva Investigational Site 31180
Teva Investigational Site 33040
Teva Investigational Site 60040
Teva Investigational Site 50391
Teva Investigational Site 53350
Teva Investigational Site 32605
Teva Investigational Site 53346
Teva Investigational Site 13483
Teva Investigational Site 13471
Teva Investigational Site 53351
Teva Investigational Site 35201
Teva Investigational Site 32606
Teva Investigational Site 13485
Teva Investigational Site 13481
Teva Investigational Site 53352
Teva Investigational Site 31179
Teva Investigational Site 50378
Teva Investigational Site 35214

summary: The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.


acronym: CARD

title: A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)

ReferenceCitation: de Wit R, Wülfing C, Castellano D, Kramer G, Eymard JC, Sternberg CN, Fizazi K, Tombal B, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Foster MC, Ozatilgan A, Geffriaud-Ricouard C, de Bono J. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study. ESMO Open. 2021 Oct;6(5):100241. doi: 10.1016/j.esmoop.2021.100241. Epub 2021 Aug 24.

ReferenceCitation: Sternberg CN, Castellano D, de Bono J, Fizazi K, Tombal B, Wülfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, de Wit R. Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study. Eur Urol. 2021 Oct;80(4):497-506. doi: 10.1016/j.eururo.2021.06.021. Epub 2021 Jul 15.

ReferenceCitation: Fizazi K, Kramer G, Eymard JC, Sternberg CN, de Bono J, Castellano D, Tombal B, Wülfing C, Liontos M, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Oudard S, Facchini G, Poole EM, Ozatilgan A, Geffriaud-Ricouard C, Bensfia S, de Wit R. Quality of life in patients with metastatic prostate cancer following treatment with cabazitaxel versus abiraterone or enzalutamide (CARD): an analysis of a randomised, multicentre, open-label, phase 4 study. Lancet Oncol. 2020 Nov;21(11):1513-1525. doi: 10.1016/S1470-2045(20)30449-6. Epub 2020 Sep 11.

ReferenceCitation: de Wit R, de Bono J, Sternberg CN, Fizazi K, Tombal B, Wülfing C, Kramer G, Eymard JC, Bamias A, Carles J, Iacovelli R, Melichar B, Sverrisdóttir Á, Theodore C, Feyerabend S, Helissey C, Ozatilgan A, Geffriaud-Ricouard C, Castellano D; CARD Investigators. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019 Dec 26;381(26):2506-2518. doi: 10.1056/NEJMoa1911206. Epub 2019 Sep 30.

location_country:
Spain
Greece
Austria
Ireland
Italy
Netherlands
United Kingdom
France
Norway
Belgium
Iceland
Germany
Czechia

location_facility:
Investigational Site Number 276023
Investigational Site Number 040004
Investigational Site Number 380002
Investigational Site Number 203002
Investigational Site Number 528003
Investigational Site Number 380009
Investigational Site Number 276025
Investigational Site Number 040003
Investigational Site Number 372003
Investigational Site Number 276011
Investigational Site Number 250014
Investigational Site Number 528002
Investigational Site Number 380006
Investigational Site Number 250008
Investigational Site Number 380001
Investigational Site Number 276008
Investigational Site Number 276022
Investigational Site Number 250002
Investigational Site Number 276018
Investigational Site Number 056005
Investigational Site Number 276010
Investigational Site Number 276004
Investigational Site Number 276007
Investigational Site Number 578002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 250001
Investigational Site Number 203005
Investigational Site Number 250011
Investigational Site Number 578001
Investigational Site Number 724001
Investigational Site Number 380004
Investigational Site Number 528004
Investigational Site Number 724003
Investigational Site Number 056013
Investigational Site Number 826001
Investigational Site Number 276003
Investigational Site Number 276026
Investigational Site Number 203001
Investigational Site Number 250018
Investigational Site Number 352001
Investigational Site Number 528005
Investigational Site Number 300004
Investigational Site Number 056006
Investigational Site Number 250013
Investigational Site Number 040002
Investigational Site Number 056007
Investigational Site Number 056001
Investigational Site Number 300001
Investigational Site Number 276002
Investigational Site Number 276006
Investigational Site Number 372001
Investigational Site Number 250007
Investigational Site Number 056003
Investigational Site Number 276028
Investigational Site Number 300005
Investigational Site Number 380008
Investigational Site Number 724004
Investigational Site Number 250016
Investigational Site Number 203003
Investigational Site Number 250004
Investigational Site Number 250009
Investigational Site Number 250005
Investigational Site Number 380005
Investigational Site Number 250010

summary:
Primary Objective:

To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to [<=]12 months, either before or after docetaxel).

Secondary Objective:

To compare efficacy for:
Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).
Progression-free survival (PFS).
Overall survival (OS).
Tumor response rate and duration of tumor response.
Pain response and time to pain progression.
Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.
Health status and Health-related Quality of Life (HRQOL).
To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.
To evaluate safety in the 2 treatment arms.


status: Terminated

title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Israel
Turkey
Canada
Switzerland
China
Germany
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

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

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Hiroshima City Hiroshima Citizens Hospital; Urology

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego; Oddzial Urologii i Onkologii

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Helsinki University Central Hospital; Urology Clinics

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Diakonie-Klinikum Stuttgart; Urologische Klinik

location_facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

location_facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy

location_facility: Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie

location_facility: Rambam Health Care Campus; Oncology - Hafia

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

location_facility: Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

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

location_facility: GU "Institution of urology of Academy Medical science of Ukraine"

location_facility: SpecjalistycznySzpital Miejski w Toruniu; Oddział Urologii Ogólnej i Onkologicznej

location_facility: Szpital Kliniczny Dzieciątka Jezus; Oddział Urologii

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: University Hospital of Patras Medical Oncology

location_facility: Albert B. Chandler Medical Center; University of Kentucky

location_facility: Baylor College of Medicine; Gastroenterology

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Azienda Ospedaliera S. Maria - Terni; Oncologia

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Az. Osp. Cardarelli; Divisione Di Oncologia

location_facility: Tampere University Hospital; Dept Of Urology

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology

location_facility: University of Texas Health Science Center at San Antonio

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Saitama Medical University International Medical Center

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: National Cancer Center Hospital; Urology

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Chicago; Hematology/Oncology

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Turku University Central Hospital; Urology clinic

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Wake Forest University Baptist Medical Center

location_facility: SBEI of HPE "Bashkir State Medical University" of MoH RF

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Universitätsmedizin Rostock, Urologische Klinik und Poliklinik

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hirosaki University School of Medicine & Hospital; Urology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: University Hospital Motol; Department of Urology

location_facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Iwate Medical University Hospital; Urology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Friendship Hospital, Capital Medical University

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche

location_facility: Austin and Repatriation Medical Centre; Cancer Services

summary: This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for recurrence following resection. Eligible participants were randomized by a 1:1 ratio into atezolizumab group or control group.

status_simplified: Unknown


title: A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

ReferenceCitation: Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Valeria Bianchi G, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Ji Y, Wang C, Deore U, Chakravartty A, Zarate JP, Taran T, Fasching PA. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5. Erratum in: Ann Oncol. 2021 Oct;32(10):1307.

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Paré L, Martinez D, Chic N, Martínez-Sáez O, Brasó-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum in: J Clin Oncol. 2021 Nov 1;39(31):3525.

ReferenceCitation: Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020 Feb 6;382(6):514-524. doi: 10.1056/NEJMoa1911149. Epub 2019 Dec 11.

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

ReferenceCitation: Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Jordan
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Ironwood Cancer and Research Centers SC-2

location_facility: University of New Mexico Cancer Center SC

location_facility: NYU Langone Medical Center CV Research center NYU Langone Medical Center

location_facility: Oncology Specialists, SC Advocate Medical Group-Niles

location_facility: Penn State University Milton S Hershey Medical Center SC

location_facility: Moanalua Medical Center. Attn: Oncology Dept SC

location_facility: Central Coast Medical Oncology Corporation SC

location_facility: Florida Cancer Research Institute Dept of Oncology

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Virginia Mason Medical Center-Oncology SC

summary: This is a multi-center, randomized double-blind, placebo controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positive, Her2 negative, advanced breast cancer who have received no or only one line of endocrine therapy for advanced breast cancer.


acronym: MetaPHer

title: A MULTICENTER, OPEN-LABEL, SINGLE-ARM SAFETY STUDY OF HERCEPTIN® SC IN COMBINATION WITH PERJETA® AND DOCETAXEL IN TREATMENT OF PATIENTS WITH HER2−POSITIVE ADVANCED BREAST CANCER (METASTATIC OR LOCALLY RECURRENT)

ReferenceCitation: Kuemmel S, Tondini CA, Abraham J, Nowecki Z, Itrych B, Hitre E, Karaszewska B, Juárez-Ramiro A, Morales-Vásquez F, Pérez-García JM, Cardona-Huerta S, Monturus E, Sequi M, Restuccia E, Benyunes M, Martín M. Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study. Breast Cancer Res Treat. 2021 Jun;187(2):467-476. doi: 10.1007/s10549-021-06145-3. Epub 2021 Mar 21.

location_country:
Poland
Portugal
Spain
Italy
United Kingdom
Mexico
Canada
Hungary
France
Belgium
Germany
Bulgaria

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Instituto Portugues Oncologia de Coimbra Francisco Gentil, EPE

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Hopital Saint Joseph; Service de Rhumatologie

location_facility: Pole Sante Republique; Pharmacie Oncologique

location_facility: Superare Centro de Infusion S.A. de C.V.

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Ospedale Santo Stefano, Azienda USL Centro Prato

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej MSW z W-MCO w Olsztynie

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

location_facility: Johanniter-Krankenhaus Genthin - Stendal GmbH; Gynäkologie und gynäkologische Onkologie

location_facility: Onkologische Schwerpunktpraxis Dr. Joerg Schilling

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

location_facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

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

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District EOOD

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Multiprofile Hospital For Active Treatment Dr. Tota Venkova JSC

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: "Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Szent Margit Hospital; Dept. of Oncology

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

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna

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

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale Sant'Anna

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

summary: This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.


title: A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.

acronym: SAATELLITE

summary: Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

ReferenceCitation: François B, Jafri HS, Chastre J, Sánchez-García M, Eggimann P, Dequin PF, Huberlant V, Viña Soria L, Boulain T, Bretonnière C, Pugin J, Trenado J, Hernandez Padilla AC, Ali O, Shoemaker K, Ren P, Coenjaerts FE, Ruzin A, Barraud O, Timbermont L, Lammens C, Pierre V, Wu Y, Vignaud J, Colbert S, Bellamy T, Esser MT, Dubovsky F, Bonten MJ, Goossens H, Laterre PF; COMBACTE Consortium and the SAATELLITE Study Group. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infect Dis. 2021 Sep;21(9):1313-1323. doi: 10.1016/S1473-3099(20)30995-6. Epub 2021 Apr 21.

ReferenceCitation: Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, Bellamy T, Hernandez-Illas M, Jafri HS. Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother. 2016 Dec 27;61(1). pii: e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.

lead_sponsor: MedImmune LLC

location_country:
Portugal
Spain
Greece
Switzerland
Hungary
France
United States
Belgium
Germany
Czechia


acronym: MODUL

title: A Multi-Centre Randomised Clinical Trial of Biomarker-Driven Maintenance Treatment for First-Line Metastatic Colorectal Cancer (MODUL)

location_country:
Serbia
Spain
Italy
United Kingdom
Belgium
Poland
Portugal
Slovenia
Russian Federation
Argentina
Turkey
Mexico
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Brazil
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

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

location_facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Studienzentrale der II. Med. Klinik

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hopital Saint Antoine; Oncologie Medicale

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie E

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

location_facility: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

location_facility: Acibadem University School of Medicine, Adana Hospital; General Surgery

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

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

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

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

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Klinikum Magdeburg gGmbH Klinik für Allgemein- und Viszeralchirurgie

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: University Hospital of Patras Medical Oncology

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

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

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Catharina ZKHS; Inwendige Geneeskunde Afd.

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Humanitas Gavazzeni;U.O. Oncologia Medica

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Albert Schweitzer Ziekenhuis - loc Dordrecht

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

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

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A

location_facility: Klinikum Wetzlar-Braunfels, Klinik für Hämatologie/Onkologie und Palliativmedizin

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

location_facility: Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: Klinik der Ruhr-Uni Bochum; Marien-Hospital Herne

location_facility: Royal Marsden Hospital; Dept. of Medicine

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

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

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: DRK Kliniken Berlin Köpenick Darmzentrum

location_facility: Ijsselland Ziekenhuis; Inwendige Geneeskunde

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Ch De Montbeliard;Chir Generale Digestive

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

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

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Städt. Klinikum München GmbH Klinikum Neuperlach Klinik f.Hämatologie u.Onkologie

location_facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie PD Dr. Bauer, Dr. Kremers

location_facility: Studienzentrum Onkologie Ravensburg; Onkologie Ravensburg

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

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

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

location_facility: Chu Estaing; Chir Generale Digestive A Et B

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Regionshospitalet Herning; Onkologisk afdeling

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

summary: This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.


title: A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).

ReferenceType: result

ReferenceCitation: Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1.

ReferenceCitation: Kaufman HL, Russell JS, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Milella M, Brownell I, Lewis KD, Lorch JH, von Heydebreck A, Hennessy M, Nghiem P. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018 Jan 19;6(1):7. doi: 10.1186/s40425-017-0310-x.

ReferenceCitation: D'Angelo SP, Russell J, Lebbé C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL. Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):e180077. doi: 10.1001/jamaoncol.2018.0077. Epub 2018 Sep 13.

ReferenceCitation: D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbé C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Güzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1). pii: e000674. doi: 10.1136/jitc-2020-000674.

ReferenceCitation: Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbé C, Robert C, Russell J, Güzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.

ReferenceCitation: Kaufman HL, Dias Barbosa C, Guillemin I, Lambert J, Mahnke L, Bharmal M. Living with Merkel Cell Carcinoma (MCC): Development of a Conceptual Model of MCC Based on Patient Experiences. Patient. 2018 Aug;11(4):439-449. doi: 10.1007/s40271-018-0301-0.

ReferenceCitation: Bharmal M, Fofana F, Barbosa CD, Williams P, Mahnke L, Marrel A, Schlichting M. Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma. Health Qual Life Outcomes. 2017 Dec 22;15(1):247. doi: 10.1186/s12955-017-0815-5. Review. Erratum in: Health Qual Life Outcomes. 2019 Mar 27;17(1):52.

ReferenceCitation: Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2). pii: e001427. doi: 10.1136/jitc-2020-001427.

ReferenceCitation: Bharmal M, Nolte S, Lebbé C, Mortier L, Brohl AS, Fazio N, Grob JJ, Pusceddu S, Hanna GJ, Hassel JC, Kiecker F, Ellers-Lenz B, Bajars M, Güzel G, Nghiem P, Hunger M, Schlichting M, Henry-Szatkowski M, D'Angelo SP. Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab. Future Oncol. 2020 Sep;16(27):2089-2099. doi: 10.2217/fon-2020-0426. Epub 2020 Sep 17.

ReferenceCitation: Grisic AM, Xiong W, Tanneau L, Jönsson S, Friberg LE, Karlsson MO, Dai H, Zheng J, Girard P, Khandelwal A. Model-Based Characterization of the Bidirectional Interaction Between Pharmacokinetics and Tumor Growth Dynamics in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab. Clin Cancer Res. 2022 Apr 1;28(7):1363-1371. doi: 10.1158/1078-0432.CCR-21-2662.

ReferenceCitation: D'Angelo SP, Lebbé C, Mortier L, Brohl AS, Fazio N, Grob JJ, Prinzi N, Hanna GJ, Hassel JC, Kiecker F, Georges S, Ellers-Lenz B, Shah P, Güzel G, Nghiem P. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. J Immunother Cancer. 2021 Jul;9(7). pii: e002646. doi: 10.1136/jitc-2021-002646.

ReferenceCitation: Bharmal M, Nolte S, Henry-Szatkowski M, Hennessy M, Schlichting M. Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma. Health Qual Life Outcomes. 2020 May 19;18(1):145. doi: 10.1186/s12955-020-01402-3.

ReferenceCitation: Bullement A, Willis A, Amin A, Schlichting M, Hatswell AJ, Bharmal M. Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection. BMC Med Res Methodol. 2020 May 6;20(1):103. doi: 10.1186/s12874-020-00997-x.

ReferenceCitation: Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.

ReferenceCitation: Bharmal M, Guillemin I, Marrel A, Arnould B, Lambert J, Hennessy M, Fofana F. How to address the challenges of evaluating treatment benefits-risks in rare diseases? A convergent mixed methods approach applied within a Merkel cell carcinoma phase 2 clinical trial. Orphanet J Rare Dis. 2018 Jun 18;13(1):95. doi: 10.1186/s13023-018-0835-1.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

location_country:
Spain
Italy
Australia
United States
France
Japan
Germany

location_facility: Washington University School of Medicine

location_facility: Hospital General Universitario de Valencia

location_facility: Universitaetsklinikum Schleswig-Holstein - Klinik fuer Allgemeine Innere Medizin

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Peggy & Charles Stephenson Oklahoma Cancer Center

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck

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

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: The Angeles Clinic and Research Institute - West LA

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet


title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

acronym: PACIFIC

summary: A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.

ReferenceCitation: Senan S, Özgüroğlu M, Daniel D, Villegas A, Vicente D, Murakami S, Hui R, Faivre-Finn C, Paz-Ares L, Wu YL, Mann H, Dennis PA, Antonia SJ. Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial. ESMO Open. 2022 Apr;7(2):100410. doi: 10.1016/j.esmoop.2022.100410. Epub 2022 Mar 2.

ReferenceCitation: Naidoo J, Vansteenkiste JF, Faivre-Finn C, Ozguroglu M, Murakami S, Hui R, Quantin X, Broadhurst H, Newton M, Thiyagarajah P, Antonia SJ. Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. Lung Cancer. 2022 Apr;166:84-93. doi: 10.1016/j.lungcan.2022.02.003. Epub 2022 Feb 9.

ReferenceCitation: Spigel DR, Faivre-Finn C, Gray JE, Vicente D, Planchard D, Paz-Ares L, Vansteenkiste JF, Garassino MC, Hui R, Quantin X, Rimner A, Wu YL, Özgüroğlu M, Lee KH, Kato T, de Wit M, Kurata T, Reck M, Cho BC, Senan S, Naidoo J, Mann H, Newton M, Thiyagarajah P, Antonia SJ. Five-Year Survival Outcomes From the PACIFIC Trial: Durvalumab After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Apr 20;40(12):1301-1311. doi: 10.1200/JCO.21.01308. Epub 2022 Feb 2. Erratum in: J Clin Oncol. 2022 Jun 10;40(17):1965.

ReferenceCitation: Ouwens M, Darilay A, Zhang Y, Mukhopadhyay P, Mann H, Ryan J, Dennis PA. Assessing the Influence of Subsequent Immunotherapy on Overall Survival in Patients with Unresectable Stage III Non-Small Cell Lung Cancer from the PACIFIC Study. Curr Ther Res Clin Exp. 2021 Aug 12;95:100640. doi: 10.1016/j.curtheres.2021.100640. eCollection 2021.

ReferenceCitation: Socinski MA, Özgüroğlu M, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Gray JE, Park K, Vincent M, Mann H, Newton M, Dennis PA, Antonia SJ. Durvalumab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Stage III Non-Small-Cell Lung Cancer (PACIFIC). Clin Lung Cancer. 2021 Nov;22(6):549-561. doi: 10.1016/j.cllc.2021.05.009. Epub 2021 Jun 12.

ReferenceCitation: Garassino MC, Paz-Ares L, Hui R, Faivre-Finn C, Spira A, Planchard D, Özgüroğlu M, Daniel D, Vicente D, Murakami S, Langer C, Senan S, Spigel D, Rydén A, Zhang Y, O'Brien C, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab by PD-L1 expression and prior chemoradiotherapy-related variables in unresectable stage III non-small-cell lung cancer. Future Oncol. 2021 Apr;17(10):1165-1184. doi: 10.2217/fon-2020-1102. Epub 2021 Feb 15.

ReferenceCitation: Mehra R, Yong C, Seal B, van Keep M, Raad A, Zhang Y. Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective. J Natl Compr Canc Netw. 2021 Feb 2;19(2):153-162. doi: 10.6004/jnccn.2020.7621. Print 2021 Feb.

ReferenceCitation: Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19.

ReferenceCitation: Faivre-Finn C, Spigel DR, Senan S, Langer C, Perez BA, Özgüroğlu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Paz-Ares L, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ. Impact of prior chemoradiotherapy-related variables on outcomes with durvalumab in unresectable Stage III NSCLC (PACIFIC). Lung Cancer. 2021 Jan;151:30-38. doi: 10.1016/j.lungcan.2020.11.024. Epub 2020 Nov 26.

ReferenceCitation: Paz-Ares L, Spira A, Raben D, Planchard D, Cho BC, Özgüroğlu M, Daniel D, Villegas A, Vicente D, Hui R, Murakami S, Spigel D, Senan S, Langer CJ, Perez BA, Boothman AM, Broadhurst H, Wadsworth C, Dennis PA, Antonia SJ, Faivre-Finn C. Outcomes with durvalumab by tumour PD-L1 expression in unresectable, stage III non-small-cell lung cancer in the PACIFIC trial. Ann Oncol. 2020 Jun;31(6):798-806. doi: 10.1016/j.annonc.2020.03.287. Epub 2020 Mar 21.

ReferenceCitation: Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Özgüroğlu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14.

ReferenceCitation: Hui R, Özgüroğlu M, Villegas A, Daniel D, Vicente D, Murakami S, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Gray JE, Rydén A, Viviers L, Poole L, Zhang Y, Dennis PA, Antonia SJ. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study. Lancet Oncol. 2019 Dec;20(12):1670-1680. doi: 10.1016/S1470-2045(19)30519-4. Epub 2019 Oct 7.

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

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

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

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

lead_sponsor: AstraZeneca

location_country:
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United Kingdom
United States
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title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

summary: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

ReferenceCitation: Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.

ReferenceCitation: Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.

ReferenceCitation: Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.

ReferenceCitation: Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.

ReferenceCitation: Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

ReferenceCitation: Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4). pii: 1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.

ReferenceCitation: DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.

ReferenceCitation: Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.

ReferenceCitation: Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkström V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β(2)-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.

location_country:
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Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Czech Republic
Vietnam
Korea, Republic of
United States
France
Peru
South Africa
Mexico
Turkey
Bulgaria

intervention_type: Biological