intervention_type: Radiation

title: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Poland
Austria
Australia
Russian Federation
Argentina
Turkey
Norway
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 2101)

location_facility: Clatterbridge Cancer Center NHS FT ( Site 1800)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

location_facility: Ukrainian Center of Tomotherapy ( Site 2206)

location_facility: Darlington Memorial Hospital NHS Trust ( Site 1810)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0804)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1706)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2802)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0208)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 2402)

location_facility: Universitatsklinik LKH Innsbruck ( Site 0802)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 0203)

location_facility: Ospedale Santissima Annunziata ( Site 1303)

location_facility: Osaka International Cancer Institute ( Site 2812)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0016)

location_facility: Veterans Affairs Palo Alto Health Care System ( Site 3039)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0318)

location_facility: Port Macquarie Base Hospital ( Site 2500)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 2811)

location_facility: Norfolk and Norwich University Foundation NHS Trust ( Site 1805)

location_facility: National Cancer Center Hospital East ( Site 2800)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2404)

location_facility: Helse Bergen HF Haukeland Universitetssykehus ( Site 1502)

location_facility: Erciyes University Medical Faculty ( Site 2109)

location_facility: Massachusetts General Hospital-Cancer Center Protocol Office ( Site 3007)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 3012)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 2305)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0105)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2400)

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1809)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2803)

location_facility: University of Massachusetts ( Site 0029)

location_facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0305)

location_facility: Orszagos Onkologiai Intezet ( Site 2308)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1808)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2816)

location_facility: University of Yamanashi Hospital ( Site 2807)

location_facility: Oxford University Hospitals NHS Foundation Trust ( Site 1812)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0316)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 0801)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2001)

location_facility: Hacettepe University Medical Faculty ( Site 2100)

location_facility: Universitaetsklinikum Essen ( Site 1201)

location_facility: Goshen Center for Cancer Care ( Site 0022)

location_facility: Kingston Health Sciences Centre ( Site 0100)

location_facility: Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet ( Site 2310)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2116)

location_facility: University of Tsukuba Hospital ( Site 2809)

location_facility: Hospital Universitario La Fe ( Site 1603)

location_facility: Franciscan Health Indianapolis ( Site 0024)

location_facility: Hospital Universitario Quiron Madrid ( Site 1601)

location_facility: Medical Center Asklepion LLC ( Site 2208)

location_facility: I.E.U. Medical Point Hastanesi ( Site 2115)

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

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2304)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0067)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2314)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2606)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 0079)

location_facility: Meander Medisch Centrum-Studie Team Oncologie ( Site 1403)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2306)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2307)

location_facility: Centrum Onkologii im. prof. Franciszka ukaszczyka-Ambulatorium Chemioterapii ( Site 2407)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2403)

location_facility: Royal Free London NHS Foundation Trust ( Site 1813)

location_facility: Tudogyogyintezet Torokbalint ( Site 2302)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 2312)

location_facility: Hospital Britanico de Buenos Aires ( Site 0204)

location_facility: Seoul National University Hospital ( Site 2600)

location_facility: Universitaetsspital Zuerich ( Site 1700)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 2012)

location_facility: Banner MD Anderson Cancer Center ( Site 3029)

location_facility: N.N.Blokhin Russian Cancer Research center ( Site 2013)

location_facility: Medical institute named after Berezin Sergey ( Site 2009)

location_facility: Keppler Universitatsklinikum ( Site 0806)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 2813)

location_facility: William E. Kahlert Regional Cancer Center ( Site 3031)

location_facility: Sinai Hospital of Baltimore ( Site 3011)

location_facility: Policlinico Agostino Gemelli ( Site 1302)

location_facility: Universitaetsklinikum Heidelberg. ( Site 1204)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2203)

location_facility: Lehigh Valley Hospital- Cedar Crest ( Site 3005)

location_facility: Hiroshima University Hospital ( Site 2810)

location_facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 1205)

location_facility: Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0206)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0300)

location_facility: Trillium Health Partners - Credit Valley Hospital ( Site 0102)

location_facility: University of Tennessee Medical Center Knoxville ( Site 3010)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1108)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1604)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2000)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary ( Site 2014)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 3036)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1602)

location_facility: Health Sciences North Research Institute ( Site 0107)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 0026)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0110)

location_facility: Hospital Provincial del Centenario ( Site 0205)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 1100)

location_facility: Mass General / North Shore Center for Outpatient Care ( Site 3040)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 2011)

location_facility: Hematology-Oncology Associates of CNY ( Site 3055)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 2313)

location_facility: McGill University Health Centre ( Site 0113)

location_facility: Penn State University Milton S. Hershey Medical Center ( Site 0064)

location_facility: Hospital e Maternidade Celso Pierro ( Site 0313)

location_facility: UKGM Gießen/Marburg-Medical Clinic V ( Site 1210)

location_facility: Taipei Veterans General Hospital ( Site 3301)

location_facility: Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1208)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 1802)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0007)

location_facility: St. Luke's University Health Network ( Site 3006)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2207)

location_facility: Royal Brisbane and Women s Hospital ( Site 2502)

location_facility: Universitaetsklinikum Erlangen ( Site 1209)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1207)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0043)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 2202)

location_facility: University College London Hospital NHS Foundation Trust ( Site 1806)

location_facility: Aichi Cancer Center Hospital ( Site 2804)

location_facility: Oslo Universitetssykehus HF Ulleval Sykehus ( Site 1500)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 1114)

location_facility: GUZ Lipetsk Regional Oncology Dispensary ( Site 2010)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0301)

location_facility: Chungbuk National University Hospital ( Site 2605)

location_facility: Vanderbilt University Medical Center ( Site 0075)

location_facility: Tergooiziekenhuizen, locatie Hilversum-Oncology ( Site 1407)

location_facility: Kartal Training and Research Hospital ( Site 2102)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2205)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0053)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2105)

location_facility: Tri-Service General Hospital ( Site 3300)

location_facility: Kansai Medical University Hospital ( Site 2808)

location_facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 2114)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2200)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1309)

location_facility: Niigata Cancer Center Hospital ( Site 2801)

summary:
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).

The primary study hypotheses are:

SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and
SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.


ipd_sharing: No

status: Terminated

primary_purpose: Treatment

intervention_type: Drug

acronym: TD-1473 LTS UC Study

title: A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC)

study_completion_date_type: Actual

lead_sponsor: Theravance Biopharma

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

enrollment_type: Actual

location_country:
Serbia
Spain
Italy
Ukraine
United States
South Africa
Romania
Japan
Poland
Portugal
Australia
Israel
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
Georgia
Korea, Republic of
France

location_facility: Theravance Biopharma Investigational Site #2

summary: A 3-Year Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis who have participated in the Maintenance Study of Protocol 0157

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

summary: This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Exelixis

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

location_facility:
Exelixis Clinical Site #39
Exelixis Clinical Site #28
Exelixis Clinical Site #31
Exelixis Clinical Site #67
Exelixis Clinical Site #5
Exelixis Clinical Site #50
Exelixis Clinical Site #26
Exelixis Clinical Site #22
Exelixis Clinical Site #57
Exelixis Clinical Site #54
Exelixis Clinical Site #6
Exelixis Clinical Site #13
Exelixis Clinical Site #3
Exelixis Clinical Site #63
Exelixis Clinical Site #4
Exelixis Clinical Site #58
Exelixis Clinical Site #1
Exelixis Clinical Site #60
Exelixis Clinical Site #65
Exelixis Clinical Site #21
Exelixis Clinical Site #48
Exelixis Clinical Site #12
Exelixis Clinical Site #46
Exelixis Clinical Site #20
Exelixis Clinical Site #61
Exelixis Clinical Site #34
Exelixis Clinical Site #17
Exelixis Clinical Site #41
Exelixis Clinical Site #18
Exelixis Clinical Site #32
Exelixis Clinical Site #44
Exelixis Clinical Site #55
Exelixis Clinical Site #49
Exelixis Clinical Site #66
Exelixis Clinical Site #27
Exelixis Clinical Site #37
Exelixis Clinical Site #23
Exelixis Clinical Site #62
Exelixis Clinical Site #30
Exelixis Clinical Site #8
Exelixis Clinical Site #53
Exelixis Clinical Site #10
Exelixis Clinical Site #11
Exelixis Clinical Site #36
Exelixis Clinical Site #14
Exelixis Clinical Site #64
Exelixis Clinical Site #43
Exelixis Clinical Site #19
Exelixis Clinical Site #68
Exelixis Clinical Site #56
Exelixis Clinical Site #42
Exelixis Clinical Site #25
Exelixis Clinical Site #45
Exelixis Clinical Site #51
Exelixis Clinical Site #69
Exelixis Clinical Site #15
Exelixis Clinical Site #29
Exelixis Clinical Site #47
Exelixis Clinical Site #59
Exelixis Clinical Site #35
Exelixis Clinical Site #40
Exelixis Clinical Site #9
Exelixis Clinical Site #52
Exelixis Clinical Site #24
Exelixis Clinical Site #33
Exelixis Clinical Site #16
Exelixis Clinical Site #2
Exelixis Clinical Site #7
Exelixis Clinical Site #38

status_simplified: Ongoing


ipd_sharing: Yes

status: Active, not recruiting

intervention_type: Biological

title: A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants With Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

type: Registry Identifier

design_allocation: Randomized

location_country:
Poland
Spain
United Kingdom
Russian Federation
Australia
New Zealand
Argentina
Canada
Korea, Republic of
United States
Chile
China
France
Israel
Japan
Germany
Turkey

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0316)

location_facility: Nottingham City Hospital Campus ( Site 0287)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0312)

location_facility: Wakayama Medical University Hospital ( Site 0025)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0111)

location_facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0408)

location_facility: Port Macquarie Base Hospital ( Site 0001)

location_facility: Fujita Health University Hospital ( Site 0016)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0372)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 0229)

location_facility: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0570)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0064)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 0387)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0264)

location_facility: Complejo Hospitalario Universitario A Coruna ( Site 0239)

location_facility: National Medical Research Radiology Centre ( Site 0260)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0262)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412)

location_facility: North Middlesex University Hospital NHS Trust ( Site 0291)

location_facility: Hopital Cite de la Sante de Laval ( Site 0400)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0602)

location_facility: The Third Affiliated Hospital of Harbin Medical University ( Site 0100)

location_facility: National Cancer Center Hospital East ( Site 0024)

location_facility: Hospital Universitario La Fe ( Site 0233)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0310)

location_facility: Peking Union Medical College Hospital ( Site 0108)

location_facility: Fujian Provincial Cancer Hospital ( Site 0102)

location_facility: First Affiliated Hospital of The Third Military Medical University ( Site 0118)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0601)

location_facility: Cancer Hospital Chinese Academy of Medical Science ( Site 0117)

location_facility: Thomas Jefferson University Hospital ( Site 0548)

location_facility: Chungbuk National University Hospital ( Site 0062)

location_facility: First Pavlov State Medical University of Saint Petersburg-Department of Oncology ( Site 0273)

location_facility: West Cancer Center - East Campus ( Site 0544)

location_facility: Hospital Universitario Miguel Servet ( Site 0242)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0021)

location_facility: Hospital Santa Creu i Sant Pau ( Site 0241)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0267)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0318)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0313)

location_facility: Kansai Medical University Hospital ( Site 0022)

location_facility: Parkland Health & Hospital System ( Site 0576)

location_facility: Centro Oncologico Antofagasta ( Site 0386)

location_facility: Leningrad Regional Oncology Center ( Site 0271)

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii ( Site 0613)

location_facility: The Second Hospital Affiliated to AMU ( Site 0119)

location_facility: Christie NHS Foundation Trust ( Site 0275)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 0280)

location_facility: Niigata Cancer Center Hospital ( Site 0019)

location_facility: Kanazawa University Hospital ( Site 0018)

location_facility: Saint Lukes Cancer Institute ( Site 0541)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0410)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0293)

location_facility: El Camino Hospital Cancer Center ( Site 0529)

location_facility: Clinica Universidad Catolica del Maule ( Site 0385)

location_facility: The Prince Charles Hospital ( Site 0010)

location_facility: Osaka Habikino Medical Center ( Site 0020)

location_facility: L'hopital Nord-Ouest - Centre Hospitalier de Villefranche sur Saone ( Site 0149)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0171)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0603)

location_facility: Zhongshan Hospital Fudan University ( Site 0103)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0237)

location_facility: Kingston Health Sciences Centre ( Site 0414)

location_facility: Hospital Clinico San Carlos ( Site 0235)

location_facility: City Clinical Hospital 1 na. NI. Pirogov ( Site 0270)

location_facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0371)

location_facility: Southern Medical University Nanfang Hospital ( Site 0121)

location_facility: Hospital General Universitario de Alicante ( Site 0240)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0382)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0314)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0269)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0403)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 0272)

location_facility: Good Samaritan Hospital Corvallis ( Site 0521)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0317)

location_facility: SAHI Republican Clinical Oncological Dispensary of the MoH of RT ( Site 0261)

location_facility: National Cancer Center Hospital ( Site 0026)

location_facility: Severance Hospital Yonsei University Health System ( Site 0063)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0286)

location_facility: Shanghai Pulmonary Hospital ( Site 0101)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0227)

location_facility: Complejo Hospitalario de Malaga ( Site 0238)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0008)

location_facility: Hopital Cardiologique Louis Pradel ( Site 0141)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0017)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 0533)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 0369)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0367)

location_facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0123)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0124)

location_facility: Hospital General Universitario de Valencia ( Site 0231)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 0292)

location_facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 0615)

location_facility: Hospital Universitario La Paz ( Site 0236)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0142)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0380)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0166)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0383)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0109)

location_facility: UT Southwestern Medical Center ( Site 0558)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0165)

location_facility: Hamato-Onkologie Hamburg Prof. Laack und Partner ( Site 0161)

location_facility: Leeds Teaching Hospital NHS Trust. St. James University Hospital ( Site 0276)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0015)

location_facility: Abington Hospital - Asplundh Cancer Center ( Site 0575)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0244)

location_facility: Moscow Regional Oncological Dispensary ( Site 0274)

summary:
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer.

The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)

summary: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

status: Completed

ReferenceType: derived

ReferenceCitation: Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.

ReferenceCitation: Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United States
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Singapore
Brazil
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Korea, Republic of
France

location_facility: Northern California Retina Vitreous Associates

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

location_facility: Hospital de Braga; Servico de Oftalmologia

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

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

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: The Second Hospital of Jilin University; ophthalmology department

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

location_facility: Gazi University Faculty of Medicine; Department Of Ophthalmology

location_facility: Centre Ophtalmologique; Imagerie et laser

location_facility: Southwest Hospital , Third Military Medical University; Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia

location_facility: The Ohio State University Havener Eye Institute

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

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

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Daping Hospital of Third Military Medical University

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Centre Odeon; Exploration Ophtalmologique

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

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

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

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Seoul National University Bundang Hospital

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: National University Hospital; Ophthalmology Department

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

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

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

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

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

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: The Second Affiliated Hospital of Harbin Medical University; ophthalmology department

location_facility: Queen Mary Hospital; Department of Ophthalmology

intervention_type: Procedure

status_simplified: Completed


acronym: AMALEE

title: A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

lead_sponsor: Novartis Pharmaceuticals

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Lithuania
United States
Costa Rica
Peru
Belgium
South Africa
Czechia
Portugal
Austria
Russian Federation
Argentina
India
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Jordan
Finland
Thailand
France
Colombia

location_facility: Emory University School of Medicine/Winship Cancer Institute

location_facility: Mount Sinai School of Medicine CFTY720D2306

location_facility: Northwest Medical Specialties Dept.ofNW Med. Specialties

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

summary:
QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib. The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.

The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well.

Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and/or liver metastases (yes versus no).


intervention_type: Other

title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

lead_sponsor: AstraZeneca

ReferenceCitation: Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. Review.

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:
Taiwan
Brazil
Hong Kong
Spain
Italy
Russian Federation
Australia
Canada
Thailand
Vietnam
Korea, Republic of
United States
France
China
India
Mexico
Japan
Singapore

summary: A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma


title: A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)

acronym: INTREPID

summary: This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Puerto Rico
India
Israel
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France


acronym: RHEA

title: A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

location_facility: Theravance Biopharma Investigational Site (2)

location_facility: Theravance Biopharma Investigational Site #2

summary: A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.


title: A Randomized, Multicenter, Parallel-group, Phase III Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

acronym: AGENT

summary: This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

lead_sponsor: Isofol Medical AB

location_country:
Spain
Greece
Austria
Australia
Canada
Sweden
United States
France
Japan
Germany

location_facility: 276-04 - MVZ Mitte - Onkologische Schwerpunktpraxis

location_facility: 840-29 - Ashland-Bellefonte Cancer Center

location_facility: 300-02 - University General Hospital Attikon

location_facility: 724-09 - Hospital Universitario HM Sanchinarro

location_facility: 036-07 - Northern Health - Epping Hospital

location_facility: 724-06 - Hospital Universitario Reina Sofia

location_facility: 392-06 - National Cancer Center Hospital

location_facility: 250-06 - Centre Georges Francois Leclerc

location_facility: 840-27 - Charleston Hematology Oncology Associates

location_facility: 124-04 - CISSS de l'Outaouais - Hôpital de Gatineau

location_facility: 276-01 - Klinikum der Universität München - Campus Grosshadern

location_facility: 840-30 - Joliet Oncology-Hematology Associates

location_facility: 036-09 - Southern Medical Day Care Center

location_facility: 392-09 - National Hospital Organization Shikoku Cancer Center

location_facility: 276-10 - Universitärers Cancer Center Hamburg (UCCH)

location_facility: 840-34 - Banner MD Anderson Cancer Center

location_facility: 124-01 - Montreal University Health Center

location_facility: 392-12 - Saitama Medical University International Medical Center

location_facility: 840-10 - Oregon Health and Science University-Knight Cancer Institute

location_facility: 840-04 - St. Vincent Frontier Cancer Center

location_facility: 036-01 - Western Health - Sunshine Hospital

location_facility: 250-01 - Institute Hospitalier Franco-Britannique

location_facility: 724-02 - Hospital Regional Universitario Carlos Haya

location_facility: 276-08 - Carl von Basedow Klinikum Saalekrei GmbH

location_facility: 040-02 - Klinikum Klagenfurt am Wörthersee

location_facility: 840-02 - The University of Texas Health Science Center

location_facility: 036-04 - Peninsula Health - Frankston Hospital

location_facility: 036-10 - Border Medical Oncology Research Unit

location_facility: 840-12 - Rutgers Cancer Institute of New Jersey

location_facility: 124-03 - William Osler Health System - Brampton Civi Hospital

location_facility: 840-19 - University of Louisville Research Foundation Inc. (ULRF)

location_facility: 040-06 - Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: 724-04 - Hospital Unviersitario 12 de Octubre

location_facility: 840-01 - University of Southern California

location_facility: 724-01 - Vall d'Hebron Institute of Oncology

location_facility: 840-22 - University of Oklahoma Stephenson Cancer Center

location_facility: 840-14 - University of Michigan Cancer Center

location_facility: 300-06 - University General Hospital of Larissa

location_facility: 392-14 - Kansai Medical University Hospital

location_facility: 040-01 - Allgemeines Krankenhaus der Stadt Wien

location_facility: 724-07 - Hospital del la Santa Creu i Sant Pau

location_facility: 276-12 - Charité - Universitätsmedizin Berlin

location_facility: 724-03 - Instituto Oncologico Baselga - Hospital Quiron

location_facility: 392-11 - National Hospital Organization Osaka National Hospital

location_facility: 724-05 - Hospital Universitario Virgen del Rocío

location_facility: 276-02 - Universitätsklinikum Carl Gustav Carus

location_facility: 124-05 - Ottawa Hospital Research Institute

location_facility: 392-08 - St.Marianna University School of Medicine Hospital

location_facility: 392-01 - National Cancer Center Hospital East

location_facility: 840-13 - UCH-MHS d/b/a Memorial Health System

location_facility: 276-13 - Universitäres Krebszentrum Leipzig (UCCL)

location_facility: 124-10 - Thunder Bay Regional Health Research Institute


title: A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)

summary: This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.

study_type: Observational

time_perspective: Prospective

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

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
South Africa
Japan
Poland
Portugal
Austria
Australia
Russian Federation
India
Israel
Turkey
Mexico
Norway
Malaysia
Sweden
Slovakia
Bosnia and Herzegovina
Canada
Switzerland
Hungary
Germany
Bulgaria
Greece
Estonia
Finland
Algeria
France
Korea, Republic of
Netherlands


title: A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

summary:
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer.

The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.

location_country:
Spain
Italy
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Russian Federation
Australia
Israel
Turkey
Brazil
Canada
Hungary
Germany
Taiwan
Korea, Republic of
France
Chile
Colombia

location_facility: Hospital Universitario Lucus Augusti ( Site 1609)

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2910)

location_facility: Saint Vincent Hospital and Health Center ( Site 0012)

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: City Clinical Oncology Center ( Site 1505)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)

location_facility: UT Southwestern Medical Center ( Site 0046)

location_facility: National Cheng Kung University Hospital ( Site 2508)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)

location_facility: National Cancer Center Hospital ( Site 2605)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)

location_facility: Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 2800)

location_facility: Texas Oncology, P.A. - Bedford ( Site 8005)

location_facility: Presidio Ospedaliero Santa Chiara ( Site 1109)

location_facility: Centro Investigación del Cáncer James Lind ( Site 2810)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)

location_facility: Iwate Medical University Hospital ( Site 2606)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)

location_facility: Istanbul Acibadem University Atakent Hospital ( Site 1902)

location_facility: Cairns and Hinterland Hospital and Health Service ( Site 2201)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)

location_facility: FSCC of Special Types of Med. Care and Technologies ( Site 1503)

location_facility: Washington University - School of Medicine ( Site 0062)

location_facility: Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)

location_facility: China Medical University Hospital ( Site 2506)

location_facility: Sanford Gynecology Oncology ( Site 0004)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0704)

location_facility: A. Tsyb Medical Radiological Research Center ( Site 1513)

location_facility: RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)

location_facility: Kingston Health Sciences Centre ( Site 0207)

location_facility: Hokkaido University Hospital ( Site 2607)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 0400)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 1605)

location_facility: Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)

location_facility: Centre D Oncologie de Gentilly ( Site 0609)

location_facility: Gunma Prefectural Cancer Center ( Site 2609)

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

location_facility: Outeniqua Cancercare Oncology Unit ( Site 1708)

location_facility: Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

location_facility: Memorial Health University Medical Center ( Site 0011)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)

location_facility: Medipol Universite Hastanesi ( Site 1909)

location_facility: Policlinico Universitario Gemelli ( Site 1105)

location_facility: Hospital General Universitario de Valencia ( Site 1610)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2601)

location_facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

location_facility: Changhua Christian Hospital ( Site 2507)

location_facility: Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)

location_facility: Hillel Yaffe Medical Center ( Site 1011)

location_facility: Saint Dominic - Jackson Memorial Hospital ( Site 0072)

location_facility: Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)

location_facility: Hospital Provincial San Pedro de Alcantara ( Site 1607)

location_facility: Taichung Veterans General Hospital ( Site 2510)

location_facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1901)

location_facility: Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)

location_facility: MD Anderson Cancer Center at Cooper ( Site 0067)

location_facility: Instituto Valenciano de Oncologia ( Site 1601)

location_facility: Virginia Cancer Specialists, PC ( Site 8003)

location_facility: Little Company of Mary Hospital ( Site 1700)

location_facility: Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 2909)

location_facility: Disney Family Cancer Center ( Site 0042)

location_facility: Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0312)

location_facility: Pontificia Universidad Catolica de Chile ( Site 2805)

location_facility: Department of Medical Oncology ( Site 1703)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)

location_facility: Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)

location_facility: University of Arizona Cancer Center ( Site 0074)

location_facility: National Taiwan University Hospital ( Site 2502)

location_facility: Clinica Universitaria de Navarra ( Site 1600)

location_facility: Central City Clinical Hospital ( Site 2150)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)

location_facility: Niigata Cancer Center Hospital ( Site 2618)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)

location_facility: Royal Victoria Hospital McGill University Health Centre ( Site 0211)

location_facility: Dr. Sudarshan K. Sharma, LTD ( Site 0061)

location_facility: University of Iowa Hospital and Clinics ( Site 0005)

location_facility: Northeast Georgia Medical Center ( Site 0029)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)

location_facility: Staedtisches Krankenhaus Kiel GmbH ( Site 0709)

location_facility: Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)

location_facility: Northwell Health- Monter Cancer Center ( Site 0075)

location_facility: A.O. Univ. S. M. della Misericordia ( Site 1114)

location_facility: Seoul National University Bundang Hospital ( Site 2404)

location_facility: Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)

location_facility: Centro Oncologico Antofagasta ( Site 2804)

location_facility: Edith Wolfson Medical Center ( Site 1003)

location_facility: A.O.U. Federico II di Napoli ( Site 1107)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)

location_facility: ASST Lecco. Ospedale A. Manzoni ( Site 1101)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)

location_facility: Taipei Veterans General Hospital ( Site 2503)

location_facility: Uludag Universitesi Tip Fakultesi ( Site 1904)

location_facility: Sanford Roger Maris Cancer Center ( Site 0082)

location_facility: Centre Hospitalier de l'Ardenne ( Site 0303)

location_facility: Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)

location_facility: Shaare Zedek Medical Center ( Site 1005)

location_facility: Hospital Universitario de Donostia ( Site 1602)

location_facility: Miami Valley Hospital [Dayton, OH] ( Site 0073)

location_facility: Istituto Europeo di Oncologia ( Site 1100)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2501)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 0306)

location_facility: Nebraska Methodist Hospital ( Site 0063)

location_facility: Imelda Ziekenhuis Bonheiden ( Site 0301)

location_facility: Hospital Nossa Senhora Da Conceicao ( Site 2703)

location_facility: Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)

location_facility: Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0035)

location_facility: Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)

location_facility: Osaka International Cancer Institute ( Site 2617)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)

location_facility: Rush University Medical Center ( Site 0019)

location_facility: Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)

location_facility: Seoul National University Hospital ( Site 2403)

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)

location_facility: Women and Infants Hospital [Providence, RI] ( Site 0039)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1712)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0616)

location_facility: Medical Rehabilitation Center ( Site 1502)

location_facility: Orszagos Onkologiai Intezet ( Site 0800)

location_facility: Universitaetsklinikum Muenster ( Site 0720)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1707)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0801)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1508)

location_facility: National Cancer Center Hospital East ( Site 2602)

location_facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)

location_facility: St. Marianna University School of Medicine Hospital ( Site 2613)

location_facility: Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)

location_facility: National Defense Medical College Hospital ( Site 2608)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1407)

location_facility: Dartmouth Hitchcock Medical Center ( Site 0024)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2181)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0057)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)

location_facility: MI Odessa Regional Oncological Centre ( Site 2121)

location_facility: Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)

location_facility: Kyiv City Clinical Oncological Center ( Site 2140)

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

location_facility: Charite Campus Virchow-Klinikum - CVK ( Site 0700)

location_facility: Institut de Cancerologie Lucien Neuwirth ( Site 0613)

location_facility: Princess Margaret Hospital.. ( Site 0202)

location_facility: Hospital de Caridade de Ijui ( Site 2712)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)

location_facility: University of Alabama at Birmingham (UAB) ( Site 0036)

location_facility: Saitama Medical University International Medical Center ( Site 2604)

location_facility: University of the Ryukyus Hospital ( Site 2616)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)

location_facility: Bialostockie Centrum Onkologii ( Site 1412)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)

location_facility: Instituto do Cancer do Ceara ( Site 2707)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1113)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1604)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1111)


title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

summary: This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.

lead_sponsor: Alkahest, Inc.

location_country:
Australia
United States
France

location_facility: Rocky Mountain Movement Disorders Center


title: A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)

acronym: SUNRISE

summary: The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

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:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Philippines
South Africa
Czechia
Poland
Russian Federation
Argentina
India
Israel
Turkey
Malaysia
Singapore
Slovakia
Lebanon
Canada
Switzerland
Guatemala
Hungary
Germany
Bulgaria
Denmark
Greece
Vietnam
France
Colombia
Netherlands


title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)

summary:
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants.

The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Russian Federation
Australia
Turkey
Mexico
Canada
China
Germany
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0100)

location_facility: Ospedale Sacro Cuore - Don Calabria ( Site 0289)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0139)

location_facility: National Cancer Center Hospital East ( Site 0306)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0453)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0286)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0421)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0070)

location_facility: Otto-Von-Guericke-Universitaet Magdeburg ( Site 0182)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0514)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 0506)

location_facility: City Clinical Oncology Center ( Site 0446)

location_facility: Eastern Regional Medical Center, Inc. ( Site 0626)

location_facility: Southern Medical University Nanfang Hospital ( Site 0102)

location_facility: Erzurum Ataturk University Faculty of Medicine ( Site 0546)

location_facility: Oregon Health & Science University ( Site 0645)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 0164)

location_facility: Toranomon Hospital Kajigaya ( Site 0312)

location_facility: Aichi Cancer Center Hospital ( Site 0316)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 0565)

location_facility: National Cancer Center Hospital ( Site 0307)

location_facility: Beth Israel Deaconess Medical Center ( Site 0716)

location_facility: The University of Tokyo Hospital ( Site 0308)

location_facility: Sunnybrook Research Institute ( Site 0055)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0569)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 0419)

location_facility: Pyatigorsk Oncology Dispensary ( Site 0441)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0545)

location_facility: National Taiwan University Hospital ( Site 0523)

location_facility: Wuhan Union hospital Cancer Center ( Site 0105)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0141)

location_facility: Seoul National University Hospital ( Site 0462)

location_facility: Massachusetts General Hospital ( Site 0603)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0184)

location_facility: The Christie NHS Foundation Trust ( Site 0575)

location_facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 0211)

location_facility: Emory University Winship Cancer Institute ( Site 0639)

location_facility: Zhongshan Hospital Fudan University ( Site 0096)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0365)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0323)

location_facility: Hospital Universitario La Paz ( Site 0510)

location_facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 0505)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0090)

location_facility: Administradora Country SA - Clinica del Country ( Site 0146)

location_facility: Policlinico Universitario Campus Biomedico ( Site 0288)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0566)

location_facility: Fudan University Shanghai Cancer Center ( Site 0086)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0525)

location_facility: Clinica Universidad Catolica del Maule ( Site 0065)

location_facility: Tampa General Medical Group ( Site 0629)

location_facility: National Cheng Kung University Hospital ( Site 0528)

location_facility: Azienda Ospedaliero-Univers. Pisana Ospedale S. Chiara ( Site 0291)

location_facility: MTZ Clinical Research Sp. z o. o. ( Site 0427)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 0097)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0509)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0611)

location_facility: London Health Sciences Centre ( Site 0053)

location_facility: Siriraj Hospital. Mahidol Univerisity ( Site 0213)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0366)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 0548)

location_facility: Universitaetsklinikum Tuebingen ( Site 0179)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0573)

location_facility: Pacific Hematology Oncology Associates ( Site 0588)

location_facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0290)

location_facility: Taichung Veterans General Hospital ( Site 0526)

location_facility: University of Oklahoma Health Science Center ( Site 0625)

location_facility: Hiroshima University Hospital ( Site 0320)

location_facility: St Vincents Hospital Melbourne ( Site 0003)

location_facility: Central Texas Veterans Healthcare System ( Site 0617)

location_facility: University of Kansas Cancer Center ( Site 0600)

location_facility: Hacettepe Uni. Tip Fakultesi ( Site 0553)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0304)

location_facility: Harbin Medical University Cancer Hospital ( Site 0089)

location_facility: Princess Alexandra Hospital ( Site 0007)

location_facility: Monash Health-Monash Medical Centre ( Site 0004)

location_facility: Universitaetsklinikum Leipzig ( Site 0187)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 0362)

location_facility: Az Osp Univ Policlin Paolo Giaccone ( Site 0284)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0529)

location_facility: Royal Free London NHS Foundation Trust ( Site 0567)

location_facility: Universitaetsklinikum Frankfurt ( Site 0180)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0550)

location_facility: Musashino Red Cross Hospital ( Site 0310)

location_facility: Stony Brook University Medical Center - Cancer Center ( Site 0612)

location_facility: Princess Margaret Cancer Centre ( Site 0050)

location_facility: Royal Prince Alfred Hospital ( Site 0001)

location_facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0137)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0093)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 0544)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0169)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0186)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0321)

location_facility: Universitaetsklinikum Essen ( Site 0188)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0159)

location_facility: Hospital Universitari Vall d Hebron ( Site 0508)

location_facility: West China Hospital of Sichuan University ( Site 0087)

location_facility: Kagawa Prefectural Central Hospital ( Site 0325)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0621)

location_facility: Seoul National University Bundang Hospital ( Site 0464)

location_facility: Mater Misericordiae University Hospital ( Site 0241)

location_facility: Yonsei University Severance Hospital ( Site 0463)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 0355)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0513)

location_facility: Kanazawa University Hospital ( Site 0315)

location_facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 0292)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0178)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0359)

location_facility: China Medical University Hospital ( Site 0527)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0067)

location_facility: Klinikum der Universitaet Aachen - RWTH ( Site 0185)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0596)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0142)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0109)

location_facility: Yokohama City University Medical Center ( Site 0313)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0450)

location_facility: Fundacion Arturo Lopez Perez ( Site 0064)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0504)

location_facility: Bezmi Alem Universitesi Tıp Fakultesi ( Site 0547)

location_facility: First Affiliated Hospital of Anhui Medical University ( Site 0095)

location_facility: Wakayama Medical University Hospital ( Site 0318)

location_facility: Taipei Veterans General Hospital ( Site 0524)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0363)

location_facility: McGill University Health Centre ( Site 0052)

location_facility: St Vincents University Hospital ( Site 0242)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0551)

location_facility: City of Hope Comprehensive Cancer Center ( Site 0587)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0418)


acronym: ANCHOR-CRC

title: Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

lead_sponsor: Pierre Fabre Medicament

location_country:
Spain
Italy
Austria
United Kingdom
United States
France
Belgium
Japan
Netherlands

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Hospital Universitario y Politécnico La FE

location_facility: Institut Català d'Oncologia (ICO L'Hospitalet)

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: GI Research Team, The Christie NHS Foundation Trust

location_facility: Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie

location_facility: Complejo Hospitalario De Navarra S Oncologia Medica

summary: The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.


title: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib

acronym: intrigue

summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of DCC-2618 to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to DCC-2618 150 mg once daily (QD) (continuous dosing for 6 week cycles) or sunitinib 50 mg QD (6 week cycles, 4 weeks on, 2 weeks off).

ReferenceCitation: Bauer S, Jones RL, Blay JY, Gelderblom H, George S, Schöffski P, von Mehren M, Zalcberg JR, Kang YK, Razak AA, Trent J, Attia S, Le Cesne A, Su Y, Meade J, Wang T, Sherman ML, Ruiz-Soto R, Heinrich MC. Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Aug 10:JCO2200294. doi: 10.1200/JCO.22.00294. [Epub ahead of print]

ReferenceCitation: Nemunaitis J, Bauer S, Blay JY, Choucair K, Gelderblom H, George S, Schöffski P, Mehren MV, Zalcberg J, Achour H, Ruiz-Soto R, Heinrich MC. Intrigue: Phase III study of ripretinib versus sunitinib in advanced gastrointestinal stromal tumor after imatinib. Future Oncol. 2020 Jan;16(1):4251-4264. doi: 10.2217/fon-2019-0633. Epub 2019 Nov 22.

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Australia
Argentina
Israel
Norway
Sweden
Singapore
Canada
Switzerland
Hungary
Germany
Taiwan
Korea, Republic of
France
Chile
Netherlands

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Oregon Health & Science University Center for Health and Healing

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Norton Cancer Institute, Audubon Hospital Campus

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute

location_facility: Froedtert Hospital-Medical College of Wisconsin

location_facility: Clinica San Carlos de Apoquindo Red Salud UC Christs

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: University of California San Diego Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Instituto Medicao Especializado Alexander Fleming

location_facility: Universitaetsspital Zuerich, Klinik fuer Onkologie

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Montefiore Medical Center-Montefiore Medical Park

location_facility: Miami Cancer Institute at Baptist Health, Inc.

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

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: UCLA Hematology Oncology Center - Main Site

location_facility: University of Colorado Hospital - Anschutz Cancer Pavillion

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


title: A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination With Platinum Doublet Chemotherapy and Radiotherapy for Participants With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799)

summary: This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and objective response rate (ORR) by blinded independent central review (BICR).

ReferenceType: result

ReferenceCitation: Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4. doi: 10.1001/jamaoncol.2021.2301. [Epub ahead of print]

location_country:
Poland
Spain
United Kingdom
Russian Federation
Australia
New Zealand
Korea, Republic of
United States
France
Germany

location_facility: MNCCI Port Macquarie Base Hospital ( Site 0200)

location_facility: North Shore University Health System ( Site 1413)

location_facility: Hospital Universitari Vall d Hebron ( Site 1101)

location_facility: Universitatsklinikum Mannheim GmbH ( Site 0413)

location_facility: Augusta-Kranken-Anstalt Bochum ( Site 0401)

location_facility: Royal Free NHS Foundation Trust ( Site 1200)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 1434)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0408)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 0411)

location_facility: Institut du Cancer de Montpellier ( Site 0300)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0204)

location_facility: Bethanien Krankenhaus Moers ( Site 0406)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)

location_facility: Chungbuk National University Hospital ( Site 1003)

location_facility: Institut de Cancerologie Gustave Roussy ( Site 0305)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302)

location_facility: Hospital Clinic de Barcelona ( Site 1100)

location_facility: Southampton General Hospital ( Site 1204)

location_facility: UMass Memorial Medical Center ( Site 1417)

location_facility: Clinica Universitaria de Navarra ( Site 1102)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1209)

location_facility: Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1422)

location_facility: Hospital Universitario Virgen Macarena ( Site 1103)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)

location_facility: St Joseph Heritage Healthcare ( Site 1403)

location_facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813)

location_facility: St. Francis Cancer Treatment Center ( Site 1421)

location_facility: Blokhin National Medical Oncology ( Site 0902)

location_facility: Southern Medical Day Care Centre ( Site 0201)


title: A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

ReferenceCitation: Janjigian YY, Kawazoe A, Yañez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.

ReferenceCitation: Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.

location_country:
Poland
Brazil
Spain
Ireland
Italy
Australia
New Zealand
Russian Federation
United Kingdom
Ukraine
Guatemala
Korea, Republic of
United States
Chile
China
France
Israel
Japan
Germany
Turkey

location_facility: Hospital de Caridade de Ijui ( Site 0202)

location_facility: Southern Medical Day Care Centre ( Site 2207)

location_facility: Fudan University Shanghai Cancer Center ( Site 2424)

location_facility: Podolsky City Clinical Hospital ( Site 1817)

location_facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 2408)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2611)

location_facility: Soroka University Medical Center ( Site 1603)

location_facility: Seattle Cancer Care Alliance ( Site 0038)

location_facility: Ninewells Hospital and Medical School ( Site 1504)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)

location_facility: Chaim Sheba Medical Center. ( Site 1607)

location_facility: Hospital Universitario Quiron Madrid ( Site 1407)

location_facility: Clinica Universidad Catolica del Maule ( Site 0305)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)

location_facility: The Christie Hospital NHS Foundation Trust ( Site 1503)

location_facility: Medical Center Asklepion LLC ( Site 2115)

location_facility: Medizinische Hochschule Hannover ( Site 1019)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1604)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2015)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0200)

location_facility: Harbin Medical University Cancer Hospital ( Site 2407)

location_facility: Xiangya Hospital Central-South University ( Site 2426)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0913)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

location_facility: Fifth Medical Center of CPLA General Hospital ( Site 2415)

location_facility: Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1500)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2615)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1512)

location_facility: The First Hospital Of Jilin University ( Site 2402)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)

location_facility: Medical Centre LLC Oncolife ( Site 2103)

location_facility: Universita Magna Graecia di Catanzaro ( Site 1107)

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

location_facility: Kobe City Medical Center General Hospital ( Site 2614)

location_facility: City Clinical Hosp.4 of DCC ( Site 2102)

location_facility: Leningrad Regional Oncology Center ( Site 1800)

location_facility: Clinic of National Cancer Institute ( Site 2104)

location_facility: Ospedale Civile Spirito Santo ( Site 1104)

location_facility: Southeastern Regional Medical Center, Inc. ( Site 0058)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2110)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0302)

location_facility: Hopital Jean Minjoz Besancon ( Site 0901)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 2401)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)

location_facility: Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)

location_facility: University College London Hospital NHS Foundation Trust ( Site 1508)

location_facility: Niigata Cancer Center Hospital ( Site 2622)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2105)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)

location_facility: Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)

location_facility: Instituto do Cancer do Ceara ( Site 0208)

location_facility: Hospital General Universitario de Elche ( Site 1404)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0301)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0001)

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2431)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)

location_facility: MI Odessa Regional Oncological Centre ( Site 2108)

location_facility: National Cancer Center Hospital East ( Site 2605)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0203)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)

location_facility: Severance Hospital Yonsei University Health System ( Site 2700)

location_facility: Washington University School of Medicine ( Site 0040)

location_facility: IEO Istituto Europeo di Oncologia ( Site 1105)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)

location_facility: Minnesota Oncology Hematology, PA ( Site 8001)

location_facility: Tallaght University Hospital ( Site 1513)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)

location_facility: Peking Union Medical College Hospital ( Site 2419)

location_facility: University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)

location_facility: Midwestern Regional Medical Center, Inc. ( Site 0059)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)

location_facility: National Cancer Center Hospital ( Site 2612)

location_facility: Osaka International Cancer Institute ( Site 2613)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0502)

location_facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 0017)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1400)

location_facility: Blokhin National Medical Oncology ( Site 1805)

location_facility: Fujian Provincial Cancer Hospital ( Site 2418)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 1007)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0300)

location_facility: Beth Israel Deaconess Medical Center ( Site 0070)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1405)

location_facility: Kumamoto University Hospital ( Site 2601)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1401)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2625)

location_facility: Seoul National University Hospital ( Site 2703)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2606)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 1812)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2610)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)

location_facility: Osaka General Medical Center ( Site 2624)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

location_facility: Instituto Nacional del Cancer ( Site 0303)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)

location_facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)

location_facility: Manor Hospital Walsall England ( Site 1515)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)

location_facility: Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)

location_facility: Edith Wolfson Medical Center ( Site 1605)

location_facility: Hospital Universitario Central de Asturias ( Site 1402)

location_facility: Kansai Medical University Hospital ( Site 2618)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)

location_facility: Aichi Cancer Center Hospital ( Site 2617)

location_facility: Gunma Prefectural Cancer Center ( Site 2602)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

summary: The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

lead_sponsor: Sanofi

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

location_country:
Spain
Italy
Russian Federation
Australia
Estonia
Argentina
Canada
Netherlands
Switzerland
United Kingdom
Hungary
United States
France
Israel
Belgium
Japan
Germany

location_facility:
Investigational Site Number 3760004
Investigational Site Number 6430002
Investigational Site Number 2500002
Investigational Site Number 6430008
Investigational Site Number 8260003
Investigational Site Number 3760003
Investigational Site Number 8260001
Investigational Site Number 3800008
Investigational Site Number 8400003
Investigational Site Number 0360003
Investigational Site Number 2500003
Investigational Site Number 8400009
Investigational Site Number 0560001
Investigational Site Number 0320003
Investigational Site Number 2500010
Investigational Site Number 3800002
Investigational Site Number 3920002
Investigational Site Number 7240007
Investigational Site Number 3760005
Investigational Site Number 5280005
Investigational Site Number 3760002
Investigational Site Number 5280003
Investigational Site Number 5280002
Investigational Site Number 2500015
Investigational Site Number 2760003
Investigational Site Number 8400025
Investigational Site Number 2760007
Investigational Site Number 8400014
Investigational Site Number 3760001
Investigational Site Number 2760002
Investigational Site Number 3920003
Investigational Site Number 6430004
Investigational Site Number 1240003
Investigational Site Number 5280004
Investigational Site Number 8260009
Investigational Site Number 8260002
Investigational Site Number 2500005
Investigational Site Number 1240005
Investigational Site Number 8260004
Investigational Site Number 3920001
Investigational Site Number 7560001
Investigational Site Number 0360002
Investigational Site Number 3920005
Investigational Site Number 8400005
Investigational Site Number 2500011
Investigational Site Number 1240010
Investigational Site Number 0560003
Investigational Site Number 1240001
Investigational Site Number 6430003
Investigational Site Number 5280007
Investigational Site Number 8260007
Investigational Site Number 2500014
Investigational Site Number 2760008
Investigational Site Number 7240001
Investigational Site Number 7240008
Investigational Site Number 8400011
Investigational Site Number 8400002
Investigational Site Number 8400006
Investigational Site Number 2760009
Investigational Site Number 0320002
Investigational Site Number 2500004
Investigational Site Number 3800003
Investigational Site Number 3480001
Investigational Site Number 0320001
Investigational Site Number 6430001
Investigational Site Number 0360001
Investigational Site Number 3800005
Investigational Site Number 0360004
Investigational Site Number 0320005
Investigational Site Number 1240007
Investigational Site Number 3800004
Investigational Site Number 7560002
Investigational Site Number 7240002
Investigational Site Number 7240006
Investigational Site Number 8400015
Investigational Site Number 2330001
Investigational Site Number 5280008
Investigational Site Number 8400022
Investigational Site Number 2760001
Investigational Site Number 3800001
Investigational Site Number 2760004
Investigational Site Number 7240004
Investigational Site Number 2500016
Investigational Site Number 7240005

summary:
Primary Objective:

To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Secondary Objectives:

To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to:
Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.
Cumulative CS (including prednisone) exposure.
To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR.
To measure sarilumab serum concentrations in participants with PMR.
To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.


title: PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy

acronym: PONENTE

summary: This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

ReferenceCitation: Menzies-Gow A, Gurnell M, Heaney LG, Corren J, Bel EH, Maspero J, Harrison T, Jackson DJ, Price D, Lugogo N, Kreindler J, Burden A, de Giorgio-Miller A, Padilla K, Martin UJ, Garcia Gil E. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022 Jan;10(1):47-58. doi: 10.1016/S2213-2600(21)00352-0. Epub 2021 Oct 4. Erratum in: Lancet Respir Med. 2021 Dec;9(12):e114.

ReferenceCitation: Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3). pii: 00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
Colombia
Italy
Mexico
Russian Federation
Argentina
Canada
United Kingdom
Sweden
United States
France
Belgium
Germany