title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection

summary: The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.

ReferenceCitation: O'Neil B, Ison MG, Hallouin-Bernard MC, Nilsson AC, Torres A, Wilburn JM, van Duijnhoven W, Van Dromme I, Anderson D, Deleu S, Kosoglou T, Vingerhoets J, Rossenu S, Leopold L. A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study. J Infect Dis. 2022 Aug 12;226(1):109-118. doi: 10.1093/infdis/jiaa376.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Brazil
Hong Kong
Spain
Australia
Netherlands
Canada
New Zealand
Sweden
United States
France
Malaysia
Singapore
Belgium
Turkey
Germany


title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

summary: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Powles T, van der Heijden MS, Castellano D, Galsky MD, Loriot Y, Petrylak DP, Ogawa O, Park SH, Lee JL, De Giorgi U, Bögemann M, Bamias A, Eigl BJ, Gurney H, Mukherjee SD, Fradet Y, Skoneczna I, Tsiatas M, Novikov A, Suárez C, Fay AP, Duran I, Necchi A, Wildsmith S, He P, Angra N, Gupta AK, Levin W, Bellmunt J; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1574-1588. doi: 10.1016/S1470-2045(20)30541-6. Epub 2020 Sep 21. Erratum in: Lancet Oncol. 2021 Jan;22(1):e5.

ipd_sharing: Yes

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

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Brazil
Canada
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Other Identifier

title: A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

acronym: Proxima A

summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 48 months. There is a planned interim analysis around the 2-year time window for the study.

status: Terminated

study_completion_date_type: Actual

study_type: Observational

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Spain
Greece
Austria
Australia
Italy
Argentina
Canada
United Kingdom
Hungary
United States
France
Israel
Germany

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

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

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Centre ophtalmologique Rabelais; Ophtalmologie

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

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

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

location_facility: John Radcliffe Hospital; Oxford Eye Hospital

location_facility: Soroka university medical center; Ophtalmology

location_facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Northern Beaches Retina Cataract Glaucoma

location_facility: University General Hospital of Heraklion; Department of Ophthalmology

location_facility: Newcastle Eye Hospital Research Foundation

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

location_facility: Centre Paradis Monticelli; Ophtalmologie

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

location_facility: University of North Carolina; Kittner Eye Center

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: European Interbalkan Medical Center; Ophthalmology Dpt

location_facility: Università degli Studi dell'Insubria; Clinica Oculistica

location_facility: Pinderfields Hospital; Clinical Research Team, Rowan House

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

intervention_type: Other

status_simplified: Unknown


ipd_sharing: No

status: Completed

acronym: ACCUTE

title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

lead_sponsor: Atox Bio Ltd

source: euctr

ReferenceType: result

ReferenceCitation: Bulger EM, May AK, Robinson BRH, Evans DC, Henry S, Green JM, Toschlog E, Sperry JL, Fagenholz P, Martin ND, Dankner WM, Maislin G, Wilfret D, Bernard AC; ACCUTE Study Investigators. A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). Ann Surg. 2020 Sep 1;272(3):469-478. doi: 10.1097/SLA.0000000000004102.

location_country:
United States
France

location_facility: Erie County Medical Center-Affliate of SUNYat Buffalo

location_facility: Medical College of Wisconsin-Froedtert Hospital

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: Wayne State University-Detroit Receiving Hospital

location_facility: Ryder Trauma Center/Jackson Memorial Hospital

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of Maryland R Adams Cowley Shock Trauma Center

location_facility: University of Cincinnati Medical Center (UCMC)

location_facility: Wayne State University-Sinai Grace Hospital

location_facility: Texas Tech University Health Sciences Center at El Paso

location_facility: University of Arkansas for Medical Sciences

location_facility: Baylor College of Medicine-Ben Taub Hospital

location_facility: University of California, Davis Medical Center

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Wright State University & Premier Health Clinical Trials Research Alliance

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

location_facility: Emory University at Grady Memorial Hospital

location_facility: Staten Island University Hospital-Northwell Health

location_facility: Our Lady of the Lake Regional Medical Center

summary: The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

status_simplified: Completed


title: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

summary: The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

primary_purpose: Other

ReferenceCitation: Bahit MC, Vora AN, Li Z, Wojdyla DM, Thomas L, Goodman SG, Aronson R, Jordan JD, Kolls BJ, Dombrowski KE, Vinereanu D, Halvorsen S, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander JH, Lopes RD. Apixaban or Warfarin and Aspirin or Placebo After Acute Coronary Syndrome or Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Prior Stroke: A Post Hoc Analysis From the AUGUSTUS Trial. JAMA Cardiol. 2022 Jul 1;7(7):682-689. doi: 10.1001/jamacardio.2022.1166.

ReferenceCitation: Welsh RC, Dehghani P, Lopes R, Wojdyla DM, Aronson R, Granger CB, Windecker S, Vora AN, Vinereanu D, Halvorsen S, Parkhomenko A, Mehran R, Alexander JH, Goodman S. Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial. Open Heart. 2022 Feb;9(1). pii: e001892. doi: 10.1136/openhrt-2021-001892.

ReferenceCitation: Harskamp RE, Fanaroff AC, Lopes RD, Wojdyla DM, Goodman SG, Thomas LE, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH. Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention. J Am Coll Cardiol. 2022 Feb 8;79(5):417-427. doi: 10.1016/j.jacc.2021.11.035.

ReferenceCitation: Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.

ReferenceCitation: Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.

ReferenceCitation: Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11.

ReferenceCitation: Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

ReferenceCitation: Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

ReferenceCitation: Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 × 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.

lead_sponsor: Bristol-Myers Squibb

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Virgin Islands (U.S.)
Hungary
Germany
Bulgaria
Denmark
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: University of Iowa Stead Family Children's Hospital

location_facility: Clinical Trials of America LA LLC - PPDS

location_facility: Carolina Cardiology Clinical Research Institute

location_facility: Knoxville Health Managment Associates Cardiology PPM LLC

location_facility: Caprock Cardiac Center Research Institute

location_facility: Cardiovascular Associates of the Southeast, LLC

location_facility: University of North Carolina School of Medicine

location_facility: Hudson Valley Cardiovascular Practice, PC

location_facility: New York-Presbyterian Brooklyn Methodist Hospital

location_facility: Advocate Medical Group ? Cardiology and Pulmonology

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Clinical Trials of America-NC, LLC - PPDS

location_facility: Clearwater Cardiovascular and Interventional Consultants

location_facility: Duke Cardiology and Cardiovascular Surgery of Lumberton


ipd_sharing: Undecided

acronym: Study of oral cMET inhibitor INC280 in patients with EGFR wild-type, advanced NSCLC

title: A Phase II, Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC)(Geometry Mono-1)

lead_sponsor: Novartis Pharmaceuticals

design_allocation: Non-Randomized

ReferenceCitation: Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. doi: 10.1056/NEJMoa2002787.

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

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

location_country:
Taiwan
Spain
Italy
Austria
Lebanon
Mexico
Argentina
Netherlands
Russian Federation
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Norway
Belgium
Japan
Germany
Singapore

location_facility: Massachusetts General Hospital MGH Cancer Center

location_facility: VA Ann Arbor Health System VA Ann Arbor Health System

location_facility: University of Utah / Huntsman Cancer Institute Oncology

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center

location_facility: Cancer Therapy and Research Center UT Health Science Center SC-5

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: University of Iowa Hospitals & Clinics SC-3

summary: A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.


title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

ReferenceCitation: Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.

location_country:
Poland
Brazil
Serbia
Spain
Greece
Italy
Russian Federation
United Kingdom
Thailand
Ukraine
Hungary
Korea, Republic of
United States
France
China
Turkey
Romania
Japan
Germany

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Azienda Socio Sanitaria Territoriale - ASST di Monza

location_facility: Ibaraki Prefectural Central Hospital; Division of respiratory

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

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

location_facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Vanderbilt University Medical Center; Multiple Sclerosis Center

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

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

location_facility: Saint Petersburg Clinical Hospital of the Russian Academy of Sciences

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Harbin Medical University Tumor Hospital

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

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration

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

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Centre Hospitalier Regional La Reunion Site Felix Guyon

location_facility: Tokyo Medical University Hospital; Dept of Surgery

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

location_facility: Hospital d Instructions des Armees Percy

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

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

location_facility: Nagoya University Hospital; Respiratory Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

location_facility: Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

location_facility: Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

location_facility: Azienda Ospedaliera Istituti Ospitalieri

location_facility: Teo Health SA - Saint Constantin Hospital

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

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

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

location_facility: Saitama Cancer Center; Thoracic Oncology

summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.


title: Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

lead_sponsor: Amgen

ReferenceType: background

ReferenceCitation: Locatelli F, Eckert C, Hrusak O, Buldini B, Sartor M, Zugmaier G, Zeng Y, Pilankar D, Morris J, von Stackelberg A. Blinatumomab overcomes poor prognostic impact of measurable residual disease in pediatric high-risk first relapse B-cell precursor acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Aug;69(8):e29715. doi: 10.1002/pbc.29715. Epub 2022 Apr 28.

ReferenceCitation: Blinatumomabe em pacientes pediátricos com leucemia linfoblástica aguda B em primeira recidiva de alto risco: um estudo de custo-efetividade. van Beurden-Tan CHY, Ribeiro RA, Seber A, de Martino Lee ML, Marçola M, Schuetz R, Loggetto SR, Maiolino A. Jornal Brasileiro de Economia da Saúde 14(1): 41-50. 10.21115/JBES.v14.n1.p41-50

ReferenceCitation: Locatelli F, Zugmaier G, Rizzari C, Morris JD, Gruhn B, Klingebiel T, Parasole R, Linderkamp C, Flotho C, Petit A, Micalizzi C, Mergen N, Mohammad A, Kormany WN, Eckert C, Möricke A, Sartor M, Hrusak O, Peters C, Saha V, Vinti L, von Stackelberg A. Effect of Blinatumomab vs Chemotherapy on Event-Free Survival Among Children With High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2021 Mar 2;325(9):843-854. doi: 10.1001/jama.2021.0987.

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

location_country:
Spain
Italy
United Kingdom
Romania
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Switzerland
Germany
Denmark
Greece
France
Netherlands

summary: B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.


title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

ReferenceCitation: Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

location_country:
Spain
Italy
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Singapore
Slovakia
Brazil
Canada
Germany
Bulgaria
Taiwan
Latvia
France
Chile
Netherlands

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: National Cancer Center Hospital East; Thoracic Oncology

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

location_facility: *X*Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Ibaraki Prefectural Central Hospital; Division of respiratory

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Hospital Pulido Valente; Servico de Pneumologia

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

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques

location_facility: Osaka City Uni Hospital; Respiratory Medicine

location_facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital General Universitario de Valencia

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

location_facility: VU Medisch Centrum; VU University Medical Center

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: Maryland Oncology Hematology (Lanham) - USOR

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1

location_facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Kanagawa Cancer Center;Thoracic Oncology

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose

location_facility: SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

location_facility: Tokyo Medical University Hospital; Dept of Surgery

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

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Instituto Regional de Enfermedades Neoplásicas Del Norte

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

location_facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

location_facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

location_facility: Nagoya University Hospital; Respiratory Medicine

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Kyoto University Hospital, Respiratory Medicine

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

location_facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

location_facility: Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: Universität Des Saarlandes; Klinik für Innere Medizin V

location_facility: Southcoast Health System; Southcoast Centers For Cancer Care

location_facility: Centro de Investigacion; Clinica - Clinica Viedma S.A.

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices

summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.


acronym: SANDPIPER

title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

ReferenceCitation: Dent S, Cortés J, Im YH, Diéras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. doi: 10.1016/j.annonc.2020.10.596. Epub 2020 Nov 10.

location_country:
Serbia
Spain
Italy
United States
Peru
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Turkey
Mexico
Sweden
Bosnia and Herzegovina
Canada
China
Germany
Bulgaria
Taiwan
Greece
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: John Theurer Cancer Ctr at Hackensack Univ Medical Ctr

location_facility: University Hospital; Oncology and Radiotherapy

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

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

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Hospital San Jose Del Tec. de Monterrey; Oncology

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

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

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

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

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

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: University Hospital of Patras Medical Oncology

location_facility: Complex Oncological Center - Plovdiv, EOOD

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Garcia de Orta; Servico de Oncologia Medica

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Liverpool Hospital; Cancer Therapy Centre

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Pole de Cancerologie Prive Strasbourgeois

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

location_facility: AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica

location_facility: Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii

location_facility: Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

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

location_facility: ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata

location_facility: Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester

summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.


title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control

summary:
This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function.

Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

ReferenceCitation: Lemiere C, Taillé C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z. Review.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. Review.

ReferenceCitation: Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

ReferenceCitation: Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

ReferenceCitation: Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400. doi: 10.1016/S2213-2600(17)30125-X. Epub 2017 Apr 5.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Greece
Italy
Estonia
Netherlands
Argentina
Canada
Russian Federation
Ukraine
United Kingdom
United States
France
Peru
Belgium
Norway
Germany
Bulgaria
Slovakia
Czechia

intervention_type: Biological


title: A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

lead_sponsor: Janssen R&D Ireland

ReferenceCitation: Ackaert O, McDougall D, Pérez-Ruixo C, Pérez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.

ReferenceCitation: Huhn GD, Wilkin A, Mussini C, Spinner CD, Jezorwski J, El Ghazi M, Van Landuyt E, Lathouwers E, Brown K, Baugh B; AMBER and EMERALD study groups. Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1. HIV Res Clin Pract. 2020 Dec;21(6):151-167. doi: 10.1080/25787489.2020.1844520. Epub 2021 Feb 2.

ReferenceCitation: Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.

ReferenceCitation: Huhn GD, Eron JJ, Girard PM, Orkin C, Molina JM, DeJesus E, Petrovic R, Luo D, Van Landuyt E, Lathouwers E, Nettles RE, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study. AIDS Res Ther. 2019 Aug 29;16(1):23. doi: 10.1186/s12981-019-0235-1.

ReferenceCitation: Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.

location_country:
Poland
Spain
United Kingdom
Canada
Switzerland
Puerto Rico
United States
France
Belgium
Sweden

summary: The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter [copies/mL]) HIV-1 infected participants.


title: A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

summary:
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma.

The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and overall survival (OS).

ReferenceCitation: Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy. Cell. 2017 Sep 7;170(6):1109-1119.e10. doi: 10.1016/j.cell.2017.08.027. Erratum in: Cell. 2018 Aug 9;174(4):1031-1032.

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25. Review.

ReferenceCitation: Chesney JA, Ribas A, Long GV, Kirkwood JM, Dummer R, Puzanov I, Hoeller C, Gajewski TF, Gutzmer R, Rutkowski P, Demidov L, Arenberger P, Shin SJ, Ferrucci PF, Haydon A, Hyngstrom J, van Thienen JV, Haferkamp S, Guilera JM, Rapoport BL, VanderWalde A, Diede SJ, Anderson JR, Treichel S, Chan EL, Bhatta S, Gansert J, Hodi FS, Gogas H. Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma. J Clin Oncol. 2022 Aug 23:JCO2200343. doi: 10.1200/JCO.22.00343. [Epub ahead of print]

ReferenceCitation: Watanabe D, Goshima F. Oncolytic Virotherapy by HSV. Adv Exp Med Biol. 2018;1045:63-84. doi: 10.1007/978-981-10-7230-7_4. Review.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Canada
Switzerland
Hungary
Germany
Greece
Finland
Korea, Republic of
France
Netherlands


title: A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

summary: The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).

ReferenceCitation: Saad F, Efstathiou E, Attard G, Flaig TW, Franke F, Goodman OB Jr, Oudard S, Steuber T, Suzuki H, Wu D, Yeruva K, De Porre P, Brookman-May S, Li S, Li J, Thomas S, Bevans KB, Mundle SD, McCarthy SA, Rathkopf DE; ACIS Investigators. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021 Nov;22(11):1541-1559. doi: 10.1016/S1470-2045(21)00402-2. Epub 2021 Sep 30.

lead_sponsor: Aragon Pharmaceuticals, Inc.

location_country:
Brazil
Spain
United Kingdom
Russian Federation
Australia
Mexico
Argentina
Canada
Netherlands
Korea, Republic of
United States
France
South Africa
Belgium
Japan
Germany


title: Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group

summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

ReferenceCitation: Hundsberger T, Surbeck W, Hader C, Putora PM, Conen K, Roelcke U. [Meningioma: management of the most common brain tumour]. Praxis (Bern 1994). 2016 Apr 13;105(8):445-51. doi: 10.1024/1661-8157/a002320. Review. German.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Switzerland
France
Belgium
Norway
Germany

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen

location_facility: Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

location_facility: Medical University Vienna - General Hospital AKH

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

location_facility: Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

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

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta


title: Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

acronym: POP

summary: The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

time_perspective: Prospective

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

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

location_facility:
Research site
Research Site


status: Recruiting

acronym: PEACE III

title: A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.

enrollment_type: Anticipated

location_country:
Denmark
Poland
Brazil
Spain
Ireland
Italy
United Kingdom
Canada
Switzerland
France
Belgium
Norway

location_facility: Sao Camilo Oncologia - Instituto Brasileiro de Controle do Cancer

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Assistance Publique - Hopitaux de Paris - CHU Henri Mondor

location_facility: Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital

location_facility: Hamilton And District Urology Association

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Centre de sante et de services sociaux de Chicoutimi

location_facility: University Health Network - Oci Princess Margaret Hospital

location_facility: Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Instituto de Medicina Integral Professor Fernando Figueira - IMIP

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

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

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc

location_facility: Oncology Institute of Southern Switzerland - Ospedale San Giovanni

location_facility: Centro de Estudos e Pesquisa Hematologia e Oncologia

location_facility: Centro de Tratamentos de Tumores Botafogo

location_facility: The Royal Surrey County Hospital NHS Foundation Trust

summary: The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone


title: iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia

summary: The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

ReferenceCitation: Dimopoulos MA, Tedeschi A, Trotman J, García-Sanz R, Macdonald D, Leblond V, Mahe B, Herbaux C, Tam C, Orsucci L, Palomba ML, Matous JV, Shustik C, Kastritis E, Treon SP, Li J, Salman Z, Graef T, Buske C; iNNOVATE Study Group and the European Consortium for Waldenström's Macroglobulinemia. Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia. N Engl J Med. 2018 Jun 21;378(25):2399-2410. doi: 10.1056/NEJMoa1802917. Epub 2018 Jun 1.

ReferenceCitation: Dimopoulos MA, Trotman J, Tedeschi A, Matous JV, Macdonald D, Tam C, Tournilhac O, Ma S, Oriol A, Heffner LT, Shustik C, García-Sanz R, Cornell RF, de Larrea CF, Castillo JJ, Granell M, Kyrtsonis MC, Leblond V, Symeonidis A, Kastritis E, Singh P, Li J, Graef T, Bilotti E, Treon S, Buske C; iNNOVATE Study Group and the European Consortium for Waldenström's Macroglobulinemia. Ibrutinib for patients with rituximab-refractory Waldenström's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):241-250. doi: 10.1016/S1470-2045(16)30632-5. Epub 2016 Dec 10.

ReferenceCitation: Buske C, Tedeschi A, Trotman J, García-Sanz R, MacDonald D, Leblond V, Mahe B, Herbaux C, Matous JV, Tam CS, Heffner LT, Varettoni M, Palomba ML, Shustik C, Kastritis E, Treon SP, Ping J, Hauns B, Arango-Hisijara I, Dimopoulos MA. Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenström's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study. J Clin Oncol. 2022 Jan 1;40(1):52-62. doi: 10.1200/JCO.21.00838. Epub 2021 Oct 4.

ReferenceCitation: Trotman J, Buske C, Tedeschi A, Matous JV, MacDonald D, Tam CS, Tournilhac O, Ma S, Treon SP, Oriol A, Ping J, Briso EM, Arango-Hisijara I, Dimopoulos MA. Single-Agent Ibrutinib for Rituximab-Refractory Waldenström Macroglobulinemia: Final Analysis of the Substudy of the Phase III Innovate(TM) Trial. Clin Cancer Res. 2021 Nov 1;27(21):5793-5800. doi: 10.1158/1078-0432.CCR-21-1497. Epub 2021 Aug 11.

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

lead_sponsor: Pharmacyclics LLC.

location_country:
Spain
Greece
Italy
Australia
United Kingdom
Canada
United States
France
Germany

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Hospital Universitari Germans Trias i Pujol

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

location_facility: University General Hospital of Thessaloniki "AHEPA"

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine

location_facility: DIAKO Evangelische Diakonie Krankenhaus gGmbH

location_facility: Centre Hospitalier de Saint Brieuc Hopital Yves le Foll


title: A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Koch G, Ouyang J, McQuade RD, Blais JD, Czerwiec FS, Sergeyeva O; REPRISE Trial Investigators. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. N Engl J Med. 2017 Nov 16;377(20):1930-1942. doi: 10.1056/NEJMoa1710030. Epub 2017 Nov 4.

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Belgium
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Norway
Sweden
Canada
Hungary
Germany
Denmark
France
Netherlands

summary: The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)


acronym: TERRANOVA

title: A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.

ReferenceCitation: Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.

ReferenceCitation: Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramírez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.

location_country:
Croatia
Serbia
Ukraine
United States
Peru
Belgium
Philippines
Poland
Slovenia
Australia
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Bulgaria
Denmark
Taiwan
New Zealand
Thailand
Vietnam
France
Chile
Colombia

summary: The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.


title: A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (PM1116197) LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE (LATITUDE)-TIMI 60.

acronym: LATITUDE

summary: Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

ReferenceCitation: Cavender MA, O'Donoghue ML, Abbate A, Aylward P, Fox KA, Glaser RX, Park JG, Lopez-Sendon J, Steg PG, Sabatine MS, Morrow DA. Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial. Am Heart J. 2022 Jan;243:147-157. doi: 10.1016/j.ahj.2021.08.022. Epub 2021 Sep 8.

ReferenceCitation: O'Donoghue ML, Glaser R, Cavender MA, Aylward PE, Bonaca MP, Budaj A, Davies RY, Dellborg M, Fox KA, Gutierrez JA, Hamm C, Kiss RG, Kovar F, Kuder JF, Im KA, Lepore JJ, Lopez-Sendon JL, Ophuis TO, Parkhomenko A, Shannon JB, Spinar J, Tanguay JF, Ruda M, Steg PG, Theroux P, Wiviott SD, Laws I, Sabatine MS, Morrow DA; LATITUDE-TIMI 60 Investigators. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1591-9. doi: 10.1001/jama.2016.3609.

ReferenceCitation: O'Donoghue ML, Glaser R, Aylward PE, Cavender MA, Crisp A, Fox KA, Laws I, Lopez-Sendon JL, Steg PG, Theroux P, Sabatine MS, Morrow DA. Rationale and design of the LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE trial. Am Heart J. 2015 May;169(5):622-630.e6. doi: 10.1016/j.ahj.2015.02.012. Epub 2015 Feb 23.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Mexico
Norway
Sweden
Slovakia
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
New Zealand
Thailand
Korea, Republic of
France
Chile
Netherlands


title: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects With a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial

summary: This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

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

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Ukraine
Korea, Republic of
United States
Chile
France
Belgium
Japan
Germany
Czechia


acronym: ADJUNCT TWO™

title: A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial

lead_sponsor: Novo Nordisk A/S

type: Registry Identifier

ReferenceCitation: Ahrén B, Hirsch IB, Pieber TR, Mathieu C, Gómez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.

ReferenceCitation: Hoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19.

ReferenceCitation: Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28. Erratum in: Diabetes Obes Metab. 2022 Nov;24(11):2280.

location_country:
Denmark
Spain
Italy
Austria
Canada
Finland
Sweden
United States
France
South Africa
Belgium
Netherlands
Bulgaria

summary: This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.


title: A Phase II,Non-comparative,Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen

acronym: ATLANTIC

summary: A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

ReferenceCitation: Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

ReferenceCitation: Garassino MC, Cho BC, Kim JH, Mazières J, Vansteenkiste J, Lena H, Jaime JC, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Poole L, Wadsworth C, Dennis PA, Rizvi NA. Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study. Lung Cancer. 2020 Sep;147:137-142. doi: 10.1016/j.lungcan.2020.06.032. Epub 2020 Jun 30.

ReferenceCitation: Ouwens MJNM, Mukhopadhyay P, Zhang Y, Huang M, Latimer N, Briggs A. Estimating Lifetime Benefits Associated with Immuno-Oncology Therapies: Challenges and Approaches for Overall Survival Extrapolations. Pharmacoeconomics. 2019 Sep;37(9):1129-1138. doi: 10.1007/s40273-019-00806-4.

ReferenceCitation: Garassino MC, Cho BC, Kim JH, Mazières J, Vansteenkiste J, Lena H, Corral Jaime J, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Huang Y, Wadsworth C, Dennis PA, Rizvi NA; ATLANTIC Investigators. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol. 2018 Apr;19(4):521-536. doi: 10.1016/S1470-2045(18)30144-X. Epub 2018 Mar 12.

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

location_country:
Poland
Taiwan
Spain
Italy
Austria
United Kingdom
Canada
Thailand
Hungary
Philippines
Korea, Republic of
United States
France
Singapore
Belgium
Japan
Germany
Czechia


title: A Study of IPI-145 and Ofatumumab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07

summary: A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or Ofatumumab in Study IPI-145-07.

lead_sponsor: SecuraBio

location_country:
Spain
Italy
Austria
Australia
New Zealand
United Kingdom
Hungary
United States
France
Belgium
Germany


title: A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

ReferenceCitation: Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Krämer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Yin O. Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021 Apr;87(4):513-523. doi: 10.1007/s00280-020-04204-y. Epub 2021 Jan 8.

ReferenceCitation: Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Krämer A, Dombret H, Hogge D, Jonas BA, Leung AY, Mehta P, Montesinos P, Radsak M, Sica S, Arunachalam M, Holmes M, Kobayashi K, Namuyinga R, Ge N, Yver A, Zhang Y, Levis MJ. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):984-997. doi: 10.1016/S1470-2045(19)30150-0. Epub 2019 Jun 4. Erratum in: Lancet Oncol. 2019 Jul;20(7):e346.

ReferenceCitation: Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Croatia
Poland
Hong Kong
Serbia
Spain
Italy
Taiwan
Australia
Netherlands
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Singapore
Belgium
Germany
Czechia

location_facility: Unità Operativa di Ematologia e Unità Operativa CTMO

location_facility: Washington University School of Medicine

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: UNC Linebreger Comprehensive Cancer Center

location_facility: LSU Health Sciences Center Feist Weiller Cancer Center

location_facility: Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika

location_facility: Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie

location_facility: Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn

location_facility: University of Kansas Medical Center Research Institute Inc

location_facility: The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University of Southern California, Norris Comprehensive Cancer Center

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

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: University of Pennsylvania Health System

location_facility: Penn State Milton S Hershey Medical Center

location_facility: MD Anderson Center, The University of Texas

location_facility: Princess Margaret Cancer Centre Princess Margaret Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont

location_facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Seoul National University Bundang Hospital

location_facility: L'UOC di Ematologia del Policlinico Tor Vergata

location_facility: Hopital Haut Leveque Centre Francois Magendie

location_facility: Uniklinik Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Stanford University Medical Center Stanford Comprehensive Cancer Center

location_facility: Duke Cancer Institute at Duke University Health System

location_facility: Oregon Health and Science University Knight Cancer Institute


title: A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

summary: This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell tumor/non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO) Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease assessments) prior to the start of treatment to determine their eligibility for enrollment in the study.

ReferenceCitation: Kreitman RJ, Moreau P, Ravandi F, Hutchings M, Gazzah A, Michallet AS, Wainberg ZA, Stein A, Dietrich S, de Jonge MJA, Willenbacher W, De Grève J, Arons E, Ilankumaran P, Burgess P, Gasal E, Subbiah V. Dabrafenib plus trametinib in patients with relapsed/refractory BRAF V600E mutation-positive hairy cell leukemia. Blood. 2022 Sep 15. pii: blood.2021013658. doi: 10.1182/blood.2021013658. [Epub ahead of print]

ReferenceCitation: Wen PY, Stein A, van den Bent M, De Greve J, Wick A, de Vos FYFL, von Bubnoff N, van Linde ME, Lai A, Prager GW, Campone M, Fasolo A, Lopez-Martin JA, Kim TM, Mason WP, Hofheinz RD, Blay JY, Cho DC, Gazzah A, Pouessel D, Yachnin J, Boran A, Burgess P, Ilankumaran P, Gasal E, Subbiah V. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2022 Jan;23(1):53-64. doi: 10.1016/S1470-2045(21)00578-7. Epub 2021 Nov 24.

ReferenceCitation: Subbiah V, Lassen U, Élez E, Italiano A, Curigliano G, Javle M, de Braud F, Prager GW, Greil R, Stein A, Fasolo A, Schellens JHM, Wen PY, Viele K, Boran AD, Gasal E, Burgess P, Ilankumaran P, Wainberg ZA. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020 Sep;21(9):1234-1243. doi: 10.1016/S1470-2045(20)30321-1. Epub 2020 Aug 17.

ReferenceCitation: Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600-Mutant Anaplastic Thyroid Cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. doi: 10.1200/JCO.2017.73.6785. Epub 2017 Oct 26.

ReferenceCitation: Lee EQ, Ruland S, LeBoeuf NR, Wen PY, Santagata S. Successful Treatment of a Progressive BRAF V600E-Mutated Anaplastic Pleomorphic Xanthoastrocytoma With Vemurafenib Monotherapy. J Clin Oncol. 2016 Apr 1;34(10):e87-9. doi: 10.1200/JCO.2013.51.1766. Epub 2014 Aug 4.

location_country:
Denmark
Spain
Italy
Austria
Netherlands
Canada
Sweden
Korea, Republic of
United States
France
Norway
Belgium
Japan
Germany


title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks

summary: A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

location_country:
Poland
Spain
Italy
Austria
Russian Federation
United Kingdom
Sweden
France
Belgium
Germany


title: A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)

summary: A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

ReferenceCitation: Flinn IW, Hillmen P, Montillo M, Nagy Z, Illés Á, Etienne G, Delgado J, Kuss BJ, Tam CS, Gasztonyi Z, Offner F, Lunin S, Bosch F, Davids MS, Lamanna N, Jaeger U, Ghia P, Cymbalista F, Portell CA, Skarbnik AP, Cashen AF, Weaver DT, Kelly VM, Turnbull B, Stilgenbauer S. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018 Dec 6;132(23):2446-2455. doi: 10.1182/blood-2018-05-850461. Epub 2018 Oct 4.


title: A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)

acronym: METRIC

summary: The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

lead_sponsor: Celldex Therapeutics

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

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Joint Ludwig-Austin Dept of Medical Oncology

location_facility: Hospital Clinico Universitario de Valencia

location_facility: USC Norris Comprehensive Cancer Center and Hospital

location_facility: Louisiana State University Health New Orleans

location_facility: Algoma District Cancer Program Sault Area Hospital

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftaimico

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST

location_facility: Cleveland Clinic-Taussig Cancer Institute-R35

location_facility: University of Texas Health Science Center at Houston

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

location_facility: Signal Point Clinical Research Center, LLC

location_facility: University of South Alabama Cancer Research Insititute

location_facility: Charleston Hematology Oncology Associates (CHOA)

location_facility: Centre Hospitalier de Mont de Marson - Hôpital Layné

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Winship Cancer Institute, Emory University

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Sunnybrook Health Sciences Centre Odette Cancer Center

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

location_facility: University of Miami Miller School of Medicine

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Nottingham University Hospitals NHS Trust

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

location_facility: University of Arkansas for Medical Sciences

location_facility: University of California Davis Medical Center

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Hospital Universitario Central de Asturias

location_facility: Universite de Montreal-Hopital Du Sacre-Coeur De Montreal

location_facility: Texas Tech University Health Sciences Center