status: Completed

title: A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy

lead_sponsor: Bayer

ReferenceCitation: Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, García Del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. J Clin Oncol. 2022 Oct 14:JCO2102303. doi: 10.1200/JCO.21.02303. [Epub ahead of print]

ReferenceCitation: Grünewald S, Politz O, Bender S, Héroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Singapore
Sweden
Slovakia
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

location_facility: Kobe City Medical Center General Hospital

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Herlev Hospital - Oncology Research Dept.

location_facility: Niigata University Medical and Dental Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: IRST Istituto Scientifico Romagnolo per studio e cura tumori

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Saitama Medical University International Medical Center

location_facility: Huadong Hospital, Affiliated to Fudan University

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: FuJian Medical University Union Hospital

location_facility: Fifth Medical Center, General Hospital of the Chinese People

location_facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu

location_facility: Princess Margaret Hospital-University Health Network

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Krasnoyarsk Regional Clinical Oncology Dispensary

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

summary:
This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.

The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors.

At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

status_simplified: Completed


type: EudraCT Number

title: A Phase 1, First-in-Human, Multicenter, Open-Label, Two-Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma

summary: The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Ichnos Sciences SA

location_country:
United States
France

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: University of Arkansas for Medical Sciences (UAMS)

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Mayo Clinic Cancer Center (MCCC) - Rochester

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)

acronym: SOTA-INS

summary:
Primary Objective:

To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).

Secondary Objectives:

To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.
To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.
To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Lexicon Pharmaceuticals

location_country:
United Kingdom
Canada
Hungary
United States
France
Bulgaria
Slovakia
Czechia

location_facility:
Investigational Site Number 2036006
Investigational Site Number 3486002
Investigational Site Number 8406032
Investigational Site Number 7036005
Investigational Site Number 3486009
Investigational Site Number 1006009
Investigational Site Number 1246003
Investigational Site Number 3486008
Investigational Site Number 8406030
Investigational Site Number 1246001
Investigational Site Number 8406003
Investigational Site Number 8266003
Investigational Site Number 8406025
Investigational Site Number 8406015
Investigational Site Number 8406009
Investigational Site Number 7036009
Investigational Site Number 8406018
Investigational Site Number 8406034
Investigational Site Number 2506011
Investigational Site Number 8406039
Investigational Site Number 8406024
Investigational Site Number 1006001
Investigational Site Number 8406008
Investigational Site Number 7036003
Investigational Site Number 8406050
Investigational Site Number 8266006
Investigational Site Number 2506003
Investigational Site Number 8406013
Investigational Site Number 8406054
Investigational Site Number 2506007
Investigational Site Number 2506010
Investigational Site Number 7036007
Investigational Site Number 7036006
Investigational Site Number 8406037
Investigational Site Number 8406001
Investigational Site Number 7036001
Investigational Site Number 8406043
Investigational Site Number 3486005
Investigational Site Number 8406010
Investigational Site Number 8406005
Investigational Site Number 8406017
Investigational Site Number 8406047
Investigational Site Number 3486003
Investigational Site Number 2506002
Investigational Site Number 8406006
Investigational Site Number 8406027
Investigational Site Number 2036001
Investigational Site Number 2036007
Investigational Site Number 8406046
Investigational Site Number 7036008
Investigational Site Number 1006010
Investigational Site Number 8406052
Investigational Site Number 1006002
Investigational Site Number 1006007
Investigational Site Number 8266004
Investigational Site Number 8266002
Investigational Site Number 2506004
Investigational Site Number 8406040
Investigational Site Number 8406038
Investigational Site Number 8406044
Investigational Site Number 8406036
Investigational Site Number 2506005
Investigational Site Number 1006005
Investigational Site Number 2036008
Investigational Site Number 8266001
Investigational Site Number 2506006
Investigational Site Number 8406019
Investigational Site Number 1006004
Investigational Site Number 8406026
Investigational Site Number 7036004
Investigational Site Number 8406014
Investigational Site Number 1006003
Investigational Site Number 8266008
Investigational Site Number 3486006
Investigational Site Number 8406045
Investigational Site Number 3486007
Investigational Site Number 7036011
Investigational Site Number 8406042
Investigational Site Number 8406002
Investigational Site Number 8406023
Investigational Site Number 3486001
Investigational Site Number 2506009
Investigational Site Number 8406011
Investigational Site Number 8406031
Investigational Site Number 1246004
Investigational Site Number 2506008
Investigational Site Number 8406020
Investigational Site Number 1246002
Investigational Site Number 8406028
Investigational Site Number 8406004
Investigational Site Number 2036003
Investigational Site Number 2506012
Investigational Site Number 2036005
Investigational Site Number 1006006
Investigational Site Number 8406033
Investigational Site Number 8406021
Investigational Site Number 2036002
Investigational Site Number 8406029
Investigational Site Number 8406048
Investigational Site Number 8406016
Investigational Site Number 8406051
Investigational Site Number 8406022
Investigational Site Number 7036010
Investigational Site Number 8406035
Investigational Site Number 8406053
Investigational Site Number 1246005

intervention_type: Drug


title: Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

acronym: PHOENICS

summary: The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Buhre W, de Korte-de Boer D, de Abreu MG, Scheeren T, Gruenewald M, Hoeft A, Spahn DR, Zarbock A, Daamen S, Westphal M, Brauer U, Dehnhardt T, Schmier S, Baron JF, De Hert S, Gavranović Ž, Cholley B, Vymazal T, Szczeklik W, Bornemann-Cimenti H, Soro Domingo MB, Grintescu I, Jankovic R, Belda J. Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study. Trials. 2022 Feb 22;23(1):168. doi: 10.1186/s13063-022-06058-6.

ReferenceCitation: Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7.

lead_sponsor: Fresenius Kabi

location_country: Croatia Poland Romania Spain Austria Netherlands France Belgium Germany Czechia

location_facility: University Hospital Schleswig-Holstein Campus Kiel

location_facility: University Medical Center (UMC) Maastricht

location_facility: Jagiollonian University Hospital Medical College

location_facility: Social Medical Center East - Donauspital

location_facility: Karol Marcinkowski Medical University in Poznań

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Hospital Universitari i Politecnic la Fe

location_facility: Hospital Universitario Fundacion Alcorcon


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies

acronym: AFFINITY

summary:
The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS.

The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.

status: Terminated

ReferenceCitation: Hanf KJM, Arndt JW, Liu Y, Gong BJ, Rushe M, Sopko R, Massol R, Smith B, Gao Y, Dalkilic-Liddle I, Lee X, Mojta S, Shao Z, Mi S, Pepinsky RB. Functional activity of anti-LINGO-1 antibody opicinumab requires target engagement at a secondary binding site. MAbs. 2020 Jan-Dec;12(1):1713648. doi: 10.1080/19420862.2020.1713648.

lead_sponsor: Biogen

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Switzerland
Hungary
United States
France
Israel
Belgium
Germany
Czechia

status_simplified: Unknown


title: A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

summary: The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

ReferenceCitation: Kastritis E, Palladini G, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Sanchorawala V, Gibbs S, Mollee P, Venner CP, Lu J, Schönland S, Gatt ME, Suzuki K, Kim K, Cibeira MT, Beksac M, Libby E, Valent J, Hungria V, Wong SW, Rosenzweig M, Bumma N, Huart A, Dimopoulos MA, Bhutani D, Waxman AJ, Goodman SA, Zonder JA, Lam S, Song K, Hansen T, Manier S, Roeloffzen W, Jamroziak K, Kwok F, Shimazaki C, Kim JS, Crusoe E, Ahmadi T, Tran N, Qin X, Vasey SY, Tromp B, Schecter JM, Weiss BM, Zhuang SH, Vermeulen J, Merlini G, Comenzo RL; ANDROMEDA Trial Investigators. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021 Jul 1;385(1):46-58. doi: 10.1056/NEJMoa2028631.

ReferenceCitation: Palladini G, Kastritis E, Maurer MS, Zonder J, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Bumma N, Kaufman JL, Medvedova E, Kovacsovics T, Rosenzweig M, Sanchorawala V, Qin X, Vasey SY, Weiss BM, Vermeulen J, Merlini G, Comenzo RL. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood. 2020 Jul 2;136(1):71-80. doi: 10.1182/blood.2019004460.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Australia
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands

location_facility: Centro de Investigación Farmacéutica Especializada

location_facility: Washington University School of Medicine

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Winship Cancer Institute Emory University

location_facility: Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo

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

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik V

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

location_facility: Sociedade Pernambucana de Combate ao Cancer

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Wake Forest University Health Sciences - Cardiovascular Medicine

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

location_facility: Semmelweis Egyetem I.Belgyogyaszati Klinika

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: University of Pennsylvania Medical Center

location_facility: Istanbul University Istanbul Medical Faculty

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

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: University Hospitals Birmingham NHS Trust,

location_facility: HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: First affiliated Hospital of Zhejiang University


ipd_sharing: Yes

acronym: Ph 3 Placebo-Controlled Trial of Adjuvant MK-3475 in RCC Post Nephrectomy

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

source: euctr

ReferenceCitation: Powles T, Tomczak P, Park SH, Venugopal B, Ferguson T, Symeonides SN, Hajek J, Gurney H, Chang YH, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Burgents JE, Xu L, Imai K, Quinn DI, Choueiri TK; KEYNOTE-564 Investigators. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1133-1144. doi: 10.1016/S1470-2045(22)00487-9.

ReferenceCitation: Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Chang YH, Hajek J, Symeonides SN, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Gurney H, Chevreau C, Melichar B, Kopyltsov E, Alva A, Burke JM, Doshi G, Topart D, Oudard S, Hammers H, Kitamura H, Bedke J, Perini RF, Zhang P, Imai K, Willemann-Rogerio J, Quinn DI, Powles T; KEYNOTE-564 Investigators. Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. N Engl J Med. 2021 Aug 19;385(8):683-694. doi: 10.1056/NEJMoa2106391.

ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Brazil
Canada
Germany
Taiwan
Ireland
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)

location_facility: St. Luke's University Health Network ( Site 0042)

location_facility: Instituto Valenciano de Oncologia ( Site 1804)

location_facility: Casa de Saude Santa Marcelina ( Site 1006)

location_facility: Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)

location_facility: Keski-Suomen keskussairaala ( Site 2303)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0038)

location_facility: The Christie NHS Foundation Trust ( Site 1602)

location_facility: Oncology Hematology Care, Inc. ( Site 8008)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0807)

location_facility: Seoul National University Hospital ( Site 0302)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1208)

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)

location_facility: National Taiwan University Hospital ( Site 0202)

location_facility: Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)

location_facility: Dana-Farber Cancer Institute (Boston) ( Site 0007)

location_facility: Urology Associates [Nashville, TN] ( Site 0063)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 2201)

location_facility: Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)

location_facility: CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)

location_facility: Arizona Oncology Associates, PC- HAL ( Site 8018)

location_facility: Hospital Regional de La Serena ( Site 0907)

location_facility: UTHealth/Memorial Hermann Cancer Center ( Site 0001)

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)

location_facility: Sapporo Medical University Hospital ( Site 0424)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 2200)

location_facility: Hospital Universitario Infanta Cristina ( Site 1805)

location_facility: Hospital Pablo Tobon Uribe. ( Site 0805)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1316)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 1807)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0046)

location_facility: North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8013)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1013)

location_facility: Severance Hospital Yonsei University Health System ( Site 0303)

location_facility: Clinical Hospital Bashkirsky Medical State University ( Site 1202)

location_facility: St-Jerome Medical Research Inc ( Site 0103)

location_facility: Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0044)

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)

location_facility: Virginia Oncology Associates ( Site 8011)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8006)

location_facility: Nebraska Cancer Specialists ( Site 0012)

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)

location_facility: Japan Community Health care Organization Sendai Hospital ( Site 0430)

location_facility: St Vincents University Hospital ( Site 1610)

location_facility: Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)

location_facility: Centrum Medyczne Onkologii I Hipertermii ( Site 1321)

location_facility: Dr. Leon Richard Oncology Centre ( Site 0106)

location_facility: University of Iowa Hospital and Clinics ( Site 0031)

location_facility: Texas Oncology-Denton South ( Site 8016)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 1000)

location_facility: Saint George Hospital [Kogarah, Australia] ( Site 0707)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1808)

location_facility: Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0203)

location_facility: Universitaetsklinikum Frankfurt ( Site 2121)

location_facility: Niagara Health System - St. Catharines ( Site 0120)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)

location_facility: Saitama Medical University International Medical Center ( Site 0404)

location_facility: Park Nicollet Frauenshuh Cancer Center ( Site 0020)

location_facility: Fundacao Dr Amaral Carvalho ( Site 1005)

location_facility: Oncologos del Occidente S.A. ( Site 0800)

location_facility: Universitaetsklinikum Freiburg ( Site 2119)

location_facility: Instituto de Oncologia de Rosario ( Site 1100)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)

location_facility: London Regional Cancer Program - London HSC ( Site 0107)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 1214)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1605)

location_facility: The James Cook University Hospital ( Site 1606)

location_facility: Centro Oncologico de Integracion Regional. COIR ( Site 1109)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)

location_facility: Providence Regional Cancer Partnership ( Site 0016)

location_facility: Instituto Nacional del Cancer ( Site 0912)

location_facility: Hospital Militar de Santiago ( Site 0911)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0014)

location_facility: Oulun yliopistollinen sairaala - OYS ( Site 2304)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)

location_facility: University of New Mexico Cancer Center ( Site 0043)

location_facility: Istituto Nazionale Tumori Regina Elena ( Site 2009)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0902)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0019)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1800)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1801)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)

location_facility: Fakultni nemocnice v Motole ( Site 1504)

location_facility: Universitatsklinikum Dusseldorf ( Site 2108)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)

location_facility: Hopital Europeen Georges Pompidou ( Site 2206)

location_facility: Istituto Europeo di Oncologia ( Site 2000)

location_facility: Osaka City University Hospital ( Site 0428)

location_facility: Texas Oncology-Memorial City ( Site 8015)

location_facility: Helios Klinikum Berlin Buch ( Site 2125)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)

location_facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)

location_facility: Minnesota Oncology Specialist, PA ( Site 8002)

location_facility: Hospital Clinico Universidad de Chile ( Site 0905)

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)

location_facility: Taichung Veterans General Hospital ( Site 0204)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)

location_facility: University Hospital Waterford ( Site 1614)

location_facility: Administradora Country SA - Clinica del Country ( Site 0808)

location_facility: Maryland Oncology Hematology, P.A. ( Site 8020)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 1204)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)

location_facility: National Medical Research Radiology Centre ( Site 1200)

location_facility: Illinois Cancer Specialists ( Site 8001)

location_facility: Texas Oncology-Austin Central ( Site 8003)

location_facility: Manatee Medical Research Institute ( Site 0039)

location_facility: Universitaetsklinikum Essen ( Site 2116)

location_facility: Instituto Medico Alexander Fleming ( Site 1105)

location_facility: Kumamoto University Hospital ( Site 0434)

location_facility: Sociedad de Investigaciones Medicas Limitadas ( Site 0913)

location_facility: Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)

location_facility: Taipei Veterans General Hospital ( Site 0201)

location_facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)

location_facility: Northwest Medical Specialties, PLLC ( Site 0034)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0008)

location_facility: Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)

location_facility: Fairview Southdale Medical Oncology Clinic ( Site 0041)

location_facility: William Osler Health System ( Site 0115)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0904)

location_facility: Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)

location_facility: Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)

location_facility: Niigata University Medical & Dental Hospital ( Site 0421)

location_facility: IHO Corporation- Utah Cancer Specialists ( Site 0055)

location_facility: St George s Healthcare Trust ( Site 1608)

location_facility: Centro Oncologico Riojano Integral ( Site 1101)

location_facility: Hospital de Girona Dr. Josep Trueta ( Site 1806)

location_facility: Medical Oncology Ospedale San Donato ( Site 2004)

location_facility: Centro Oncologico Antofagasta ( Site 0914)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)

location_facility: University Medical Center New Orleans ( Site 0053)

location_facility: Macquarie University Hospital ( Site 0700)

location_facility: Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)

location_facility: Charleston Hematology Oncology Associates PA ( Site 8000)

location_facility: Yamaguchi University Hospital ( Site 0406)

location_facility: Georgetown University Medical Center ( Site 0002)

location_facility: Nara Medical University Hospital ( Site 0416)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)

location_facility: Rocky Mountain Cancer Center ( Site 8010)

location_facility: Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)

location_facility: COT Centro Oncologico do Triangulo Ltda ( Site 1014)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)

location_facility: Clinica Universitaria de Navarra ( Site 1803)

location_facility: Universitaetsklinikum Jena. ( Site 2104)

location_facility: Universitaetsklinikum Tuebingen ( Site 2100)

location_facility: Nippon Medical School Hospital ( Site 0400)

location_facility: China Medical University Hospital ( Site 0200)

location_facility: Woodlands Medical Specialists, PA ( Site 8021)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0059)

location_facility: Medical University of South Carolina ( Site 0033)

location_facility: Universidade de Caxias do Sul ( Site 1004)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1201)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)

location_facility: Osaka International Cancer Institute ( Site 0401)

location_facility: UT Southwestern Medical Center ( Site 0003)

location_facility: Universitaetsklinikum Schleswig Holstein ( Site 2109)

location_facility: Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1209)

location_facility: CISSS-CA Hotel Dieu de Levis ( Site 0111)

summary:
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.

The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.


title: Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

summary: The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

lead_sponsor: AB Science

location_country:
Denmark
Poland
Slovenia
Italy
Russian Federation
Spain
Ukraine
Sweden
United States
Israel
France
Norway
Germany

location_facility: Scientific Practical Medical Center "Innovation and Health"

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Johns Hopkins Medicine Brain Science Institute

location_facility: Department of Neurology, University of Ulm

location_facility: Hôpital Pasteur 2 Centre de Reference SLA et autres maladies du Neurone Moteur Pole Neurosciences Cliniques

location_facility: The State Institution of Neurology, Psychiatry and Narcology of NAMS of Ukraine

location_facility: University of Alabama at Birmingham, Department of Neurology, Division of Neuromuscular Disease

location_facility: Communal Non-Profit Enterprise of Lviv Regional Council, Lviv Regional Clinical Hospital, Neurological Department

location_facility: Tel-Aviv Medical Center Hôpital Sourasky (ICHILOV)

location_facility: Moscow city clinical Hospital after V.M. Buyanov

location_facility: Clinical Hospital Santiago de Compostela

location_facility: University of California, Irvine - ALS & Neuromuscular Center

location_facility: Medical Center of LLC Medical Center Dopomoga Plus

location_facility: Istituti Clinici Scientifici Maugeri IRCCS

location_facility: Centro Clinico NeMO Fondazione Serena Onlus

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Azienda Ospedaliero-Universitaria di Modena


acronym: CREAD 2

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohórquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Sep 19. doi: 10.1001/jamaneurol.2022.2909. [Epub ahead of print]

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
South Africa
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Norway
Sweden
Brazil
Canada
China
Germany
Denmark
Taiwan
Estonia
Korea, Republic of
France

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

location_facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies

location_facility: Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: National Taiwan University Hospital; Neurology

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Tianjin Medical University General Hospital

location_facility: National Clinical Research Inc.-Richmond

location_facility: Akershus universitetssykehus HF; Nevroklinikken S203

location_facility: University of Nebraska Medical Center; Dept of Neurological Sciences

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

location_facility: Alzheimer's Research and Treatment Center

location_facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

location_facility: Advanced Memory Research Institute of NJ

location_facility: State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa

location_facility: University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Health Partners Institute for Education and Research

location_facility: Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

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

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla

location_facility: St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: National Center of Neurology and Psychiatry

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre

location_facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

location_facility: Private Practice; the Osteoporosis Clinic

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Hospital Pedro Hispano; Servico de Neurologia

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Kaohsiung Medical University Hospital; Neurology

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Queen Elizabeth University Hospital; Clinical Research Facility

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Clinic for neurology, Clinical Center Kragujevac

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

location_facility: National Center for Geriatrics and Gerontology

location_facility: Hospital la Magdalena; Servicio de Neurologia

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Neurology clinic, Clinical Center of Serbia

location_facility: Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Charing Cross Hospital; Imperial Memory Unit, Level 10 West

location_facility: Taipei Medical University - Shuang Ho Hospital - Neurology

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Seoul National University Bundang Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Hop Guillaume Et Rene Laennec; Cmrr St Herblain

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

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

location_facility: Clinic for Mental disorders Dr Laza Lazarevic

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: University Southampton NHS Foundation Trust; Wessex Neurologica Centre

location_facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie

location_facility: Sheba Medical Center; Psychiatry Department

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: Ohio State University; College of Medicine

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care

summary: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).


title: A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion to Second Line Cervical Cancer

summary: This is a 2-part trial: a Phase 1, open-label, dose-escalation study in subjects with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in subjects with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen.

lead_sponsor: Agenus Inc.

location_country:
Poland
Brazil
Spain
Australia
Estonia
United States
Chile
France
Belgium

location_facility: Instituto do Cancer do Estado de São Paulo

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Florida Cancer Specialists & Research Institute

location_facility: The Ohio State University Comprehensive Cancer Center

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

location_facility: Swedish Medical Center-Cherry Hill Campus

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon

location_facility: Centro de Investigación Del Cáncer James Lind

location_facility: University of Southern California - Keck School of Medicine

location_facility: The University of Texas MD Anderson Caner Center

location_facility: Institute de Cancerologie de l'Ouest (ICO) - René Gauducheau


acronym: PASADENA

title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension

ReferenceCitation: Pagano G, Taylor KI, Anzures-Cabrera J, Marchesi M, Simuni T, Marek K, Postuma RB, Pavese N, Stocchi F, Azulay JP, Mollenhauer B, López-Manzanares L, Russell DS, Boyd JT, Nicholas AP, Luquin MR, Hauser RA, Gasser T, Poewe W, Ricci B, Boulay A, Vogt A, Boess FG, Dukart J, D'Urso G, Finch R, Zanigni S, Monnet A, Pross N, Hahn A, Svoboda H, Britschgi M, Lipsmeier F, Volkova-Volkmar E, Lindemann M, Dziadek S, Holiga Š, Rukina D, Kustermann T, Kerchner GA, Fontoura P, Umbricht D, Doody R, Nikolcheva T, Bonni A; PASADENA Investigators; Prasinezumab Study Group. Trial of Prasinezumab in Early-Stage Parkinson's Disease. N Engl J Med. 2022 Aug 4;387(5):421-432. doi: 10.1056/NEJMoa2202867.

ReferenceCitation: Lipsmeier F, Taylor KI, Postuma RB, Volkova-Volkmar E, Kilchenmann T, Mollenhauer B, Bamdadian A, Popp WL, Cheng WY, Zhang YP, Wolf D, Schjodt-Eriksen J, Boulay A, Svoboda H, Zago W, Pagano G, Lindemann M. Reliability and validity of the Roche PD Mobile Application for remote monitoring of early Parkinson's disease. Sci Rep. 2022 Jul 15;12(1):12081. doi: 10.1038/s41598-022-15874-4.

ReferenceCitation: Pagano G, Boess FG, Taylor KI, Ricci B, Mollenhauer B, Poewe W, Boulay A, Anzures-Cabrera J, Vogt A, Marchesi M, Post A, Nikolcheva T, Kinney GG, Zago WM, Ness DK, Svoboda H, Britschgi M, Ostrowitzki S, Simuni T, Marek K, Koller M, Sevigny J, Doody R, Fontoura P, Umbricht D, Bonni A; PASADENA Investigators; Prasinezumab Study Group. A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA): Rationale, Design, and Baseline Data. Front Neurol. 2021 Oct 1;12:705407. doi: 10.3389/fneur.2021.705407. eCollection 2021.

ReferenceCitation: Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data 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 the Sharing of Clinical 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).

location_country:
Spain
Austria
United States
France
Germany

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

location_facility: Aventura Neurologic Associates; Department of Research

location_facility: CenExel Rocky Mountain Clinical Research, LLC

location_facility: Associated Neurologists of Southern CT PC

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: University of California at San Francisco

location_facility: CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen

location_facility: Medizinische Universität Innsbruck; Universitätsklinik für Neuroradiologie

location_facility: USF Parkinsons Disease and Movement Disorders Center

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: Hopital Henri Mondor; Service de Neurologie

location_facility: University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

location_facility: Altman Clinical Translational Research Institute

location_facility: Klinik und Poliklinik für Neurologie Universitätsklinikum

location_facility: Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm

location_facility: Philipps Universität Marburg; Klinik für Neurologie

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Hospital Clinic de Barcelona; Neurologia

location_facility: Barrow Neurology Clinics; Movement Disorders Program

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

summary: This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 260 weeks.


acronym: Evaluate chemotherapy plus MK-3475 vs chemotherapy plus placebo and  MK-3475 vs placebo  for TNBC

title: A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

ReferenceCitation: Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.

ReferenceCitation: Pérez-García J, Soberino J, Racca F, Gion M, Stradella A, Cortés J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25. Review.

ReferenceCitation: Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Portugal
Russian Federation
Australia
Israel
Turkey
Sweden
Singapore
Brazil
Canada
Germany
Taiwan
Ireland
Korea, Republic of
France
Colombia

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712)

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912)

location_facility: Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910)

location_facility: Hospital Sao Lucas da PUCRS ( Site 0200)

location_facility: New England Cancer Specialists ( Site 0005)

location_facility: Peninsula Cancer Institute, LLC ( Site 0041)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0211)

location_facility: National Cancer Center Hospital ( Site 2500)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805)

location_facility: Colchester General Hospital ( Site 1508)

location_facility: Texas Oncology-San Antonio Northeast ( Site 8012)

location_facility: St Vincents University Hospital ( Site 1550)

location_facility: UT Southwestern Medical Center ( Site 0030)

location_facility: Seattle Cancer Care Alliance ( Site 0068)

location_facility: Virginia Cancer Specialists, PC ( Site 8009)

location_facility: Princess Margaret Cancer Centre ( Site 0103)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0914)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 1308)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1810)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101)

location_facility: Instituto do Cancer do Ceara ( Site 0205)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901)

location_facility: Norrlands Universitetssjukhus ( Site 1401)

location_facility: Nottingham University Hospitals NHS Trust ( Site 1505)

location_facility: The James Cook University Hospital ( Site 1515)

location_facility: Hospital Universitario San Ignacio ( Site 0401)

location_facility: St. Marianna University School of Medicine Hospital ( Site 2516)

location_facility: Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105)

location_facility: Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033)

location_facility: Severance Hospital Yonsei University Health System ( Site 2100)

location_facility: Universitaetsklinikum Erlangen ( Site 1001)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 2512)

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8008)

location_facility: Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079)

location_facility: Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403)

location_facility: Kadlec Clinic Hematology and Oncology ( Site 0087)

location_facility: UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1702)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905)

location_facility: St John of God Subiaco Hospital ( Site 2006)

location_facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907)

location_facility: CHU de la Miletrie Poitiers ( Site 0913)

location_facility: Parkland Health and Hospital System ( Site 0093)

location_facility: Universidade de Caxias do Sul ( Site 0201)

location_facility: YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004)

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801)

location_facility: Social medical corporation Hakuaikai Sagara Hospital ( Site 2508)

location_facility: HELIOS Klinikum Berlin-Buch ( Site 1005)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1713)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 8001)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1404)

location_facility: Polyclinique Bordeaux Nord Aquitaine ( Site 0911)

location_facility: Universitaets-Frauenklinik Tuebingen ( Site 1003)

location_facility: Taipei Veterans General Hospital ( Site 2302)

location_facility: CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0014)

location_facility: Hospital Clinico Univ de Valencia ( Site 1313)

location_facility: Hopital Diaconesses Croix Saint Simon ( Site 0905)

location_facility: Royal Brisbane and Women s Hospital ( Site 2003)

location_facility: Minnesota Oncology Hematology, PA ( Site 8013)

location_facility: Ozel Medicana International Ankara Hastanesi ( Site 1915)

location_facility: Hospital de Santa Maria, E.P.E. ( Site 2445)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2300)

location_facility: Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906)

location_facility: Virginia Oncology Associates ( Site 8000)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2509)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0203)

location_facility: National Hospital Organization Osaka National Hospital ( Site 2505)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701)

location_facility: Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089)

location_facility: Providence Portland Medical Center ( Site 0052)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1300)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 1504)

location_facility: National Taiwan University Hospital ( Site 2301)

location_facility: Cedars Sinai Medical Center ( Site 0091)

location_facility: Houston Methodist Cancer Center ( Site 0013)

location_facility: İstanbul University Cerrahpaşa Medical Faculty ( Site 1904)

location_facility: Goshen Center for Cancer Care ( Site 0010)

location_facility: Linkopings Universitetssjukhus ( Site 1402)

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103)

location_facility: National Cancer Centre Singapore ( Site 2600)

location_facility: North Shore University Health System ( Site 0081)

location_facility: University of Iowa Hospital and Clinics ( Site 0038)

location_facility: Hyogo College of Medicine Hospital ( Site 2506)

location_facility: Yale University School of Medicine ( Site 0054)

location_facility: National Cheng Kung University Hospital ( Site 2305)

location_facility: Baskent Unıversity Adana Kısla Hospital ( Site 1903)

location_facility: Texas Oncology-Austin Central ( Site 8005)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2501)

location_facility: Nyack Hospital Infusion Center ( Site 0059)

location_facility: Istituto Europeo di Oncologia ( Site 1106)

location_facility: University of Colorado Cancer Center ( Site 0021)

location_facility: TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044)

location_facility: Instituto De Cancerologia S.A. ( Site 0406)

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006)

location_facility: Oncologos del Occidente S.A. ( Site 0405)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806)

location_facility: Saitama Medical University International Medical Center ( Site 2513)

location_facility: Acibadem Altunizade Hastanesi ( Site 1900)

location_facility: GBU RO Regional Clinical Oncological Dispensary ( Site 1808)

location_facility: Ospedale Civile di Macerata ( Site 1104)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1301)

location_facility: Orchard Healthcare Research Inc. ( Site 0049)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 1007)

location_facility: Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1314)

location_facility: Seoul National University Hospital ( Site 2101)

location_facility: National Cancer Center Hospital East ( Site 2518)

location_facility: Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717)

location_facility: Texas Oncology-Memorial City ( Site 8003)

location_facility: The University of Chicago Medical Center ( Site 0047)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804)

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446)

location_facility: Aichi Cancer Center Hospital ( Site 2502)

location_facility: Oncology Hematology Care, Inc. ( Site 8011)

location_facility: Klinikum der Universit. Muenchen ( Site 1002)

location_facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600)

location_facility: Kumamoto University Hospital ( Site 2515)

location_facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 1908)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708)

location_facility: Hospital Universitario Reina Sofia ( Site 1304)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)

location_facility: St.Luke's International Hospital ( Site 2511)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0100)

location_facility: Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0073)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2514)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304)

summary:
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.


title: A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

summary: This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.

lead_sponsor: Sumitomo Pharma Oncology, Inc.

location_country:
Poland
Taiwan
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
Ukraine
Korea, Republic of
United States
France
China
Singapore
Belgium
Japan
Germany
Czechia

location_facility: The Center for Cancer and Blood Disorders

location_facility: Washington University School of Medicine

location_facility: St.Petersburg Medical Universitet n.a. I.P. Pavlov

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: FSBI "Russian Research Centre of Radiology and Surgical Technologies"

location_facility: Green Bay Oncology, Ltd. - West Green Bay

location_facility: Budgetary Healthcare Institution of Omsk Region

location_facility: Kaiser Permanente - Westside Medical Office

location_facility: Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center

location_facility: Torrance Health Association DBA Torrance Memorial

location_facility: Klinikum Oldenburg AöR - UK für Innere Medizin

location_facility: Hospital Clínico y Provincial de Barcelona

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Harbin Medical University Cancer Hospital

location_facility: Railway Clinical Hospital on station Chelyabinsk

location_facility: West Virginia University Mary Babb Randolph Cancer Center (MBRCC)

location_facility: Cancer Center of Guangzhou Medical University

location_facility: UF Health Cancer Center - Orlando Health

location_facility: The First Affiliated Hospital of Soochow University

location_facility: N.N. Blokhin Russian Cancer Research Center

location_facility: Maine Center for Cancer Medicine - Scarborough

location_facility: Oncology and Hematology Associates of Southwest Virginia

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: Northwestern Medicine Regional Medical Group

location_facility: General Hospital of Ningxia Medical University

location_facility: The Atlantic Clinical Cancer Research Unit (ACCRU)

location_facility: Fujian Medical University Union Hospital

location_facility: National Research Mordovia State University

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: UNM Cancer Research and Treatment Center

location_facility: Kaiser Permanente - Vallejo Medical Center

location_facility: Seoul national University Bundang Hospital

location_facility: North Shore Hematology Oncology Associates PC

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Hematology Oncology Associates of Central New York

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Winship Cancer Institute of Emory University

location_facility: UNC Chapel Hill / Lineberger Comprehensive Cancer

location_facility: University of Missouri - Ellis Fischel Cancer Cent

location_facility: The First Affiliated Hospital Zhejiang University

location_facility: Hospital Regional Universitario de Málaga

location_facility: The Second Affiliated Hospital Zhejiang University

location_facility: The 81 Hospital of the Chinese Peoples Liberation Army

location_facility: Orenburg Regional Clinical Oncology Dispensary

location_facility: Weill Cornell Medicine/ NewYork-Presbyterian

location_facility: Fox Chase Cancer Center (FCCC) - Philadelphia

location_facility: Universitatsklinik far Innere Medizin III

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Sir Run Shaw Hospital School of Medicine Zhejiang University

location_facility: Gabrail Cancer Center (GCC) - Canton Facility

location_facility: Landeskrankenhaus Medical University Innsbruck

location_facility: Georgetown University Medical Center (GUMC)

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Indiana University - Melvin and Bren Simon Cancer

location_facility: HSHS St. Vincent Hospital Regional Cancer Center

location_facility: Charleston Hematology Oncology Associates

location_facility: Aurora St. Luke's Medical Center - Vince Lombardi

location_facility: Bon Secours Cancer Institute Medical Oncology

location_facility: Ren Ji Hospital Shanghai Jiaotong University School of Medicine

location_facility: University of Toronto - St. Michael's Hospital

location_facility: Fakultni nemocnice Brno Interni hematoonkologicka klinika

location_facility: Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine

location_facility: Mercy Clinic Oncology and Hematology - McAuley

location_facility: Florida Cancer Specialists & Research Institute

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: Louisiana Hematology Oncology Associates (LHOA)

location_facility: Istituto Ricerca e la Cura del Cancro (IRCC)

location_facility: UCLA Medical Center Santa Monica Hematology And Oncology

location_facility: MultiCare Institute for Research and Innovation

location_facility: Metro MN Clinical Oncology Research Consortium

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

summary:
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone.

All patients who complete the study will have the option to enter a long term active treatment study.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Celgene

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Latvia
Finland
Korea, Republic of
France
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: University of North Carolina at Chapel Hill

location_facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin

location_facility: CHA Bundang Medical Center CHA University

location_facility: CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI

location_facility: Nottingham University Hospitals Queens Medical Centre

location_facility: University of California at San Francisco (PARENT)

location_facility: Swedish Medical Center Cancer Institute Research

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

location_facility: University of Pennsylvania School of Medicine

location_facility: Medical Research Center of Connecticut LLC

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: Johns Hopkins University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

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

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

location_facility: Gastroenterology Associates of Tidewater

location_facility: University of Utah Division of Gastroenterology

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Northwestern University-Feinberg School of Medicine

location_facility: University of Texas Health Science Center at Houston

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Clinsante S.C. Osrodek Badan Klinicznych

location_facility: Hospital General Universitario de Alicante

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Centre de sante et de services sociaux Champlain Charles Le Moyne

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: University of Washington School of Medicine

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

location_facility: SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Via Christi Research a division of Via Christi Hospitals Wichita Inc

location_facility: Gastroenterology Associates of Western Michigan PLC

location_facility: University of Southern California Medical Center

location_facility: Northshore University Healthsystem Research Institute

location_facility: Ternopil City Communal Emergency Medical Care Hospital

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: North Shore-LIJ Health System-Division of Rheumatology

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Basingstoke and North Hampshire Hospital

location_facility: The Feinstein Institute for Medical Research PRIME

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi


title: A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)

lead_sponsor: AstraZeneca

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

location_country:
Poland
Romania
Spain
United Kingdom
Australia
Canada
Hungary
Korea, Republic of
United States
France
Puerto Rico
Belgium
Japan
Germany

location_facility: The Multiple Sclerosis Center of Atlanta

location_facility: Hospital Universitario La Fe de Valencia

location_facility: The Florey Institute of Neuroscience and Mental Health

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: Tokyo Women's Medical University Hospital

location_facility: Institute for Neurodegenerative Disorders

location_facility: Australian Alzheimer's Research Foundation

location_facility: Centrum Zdrowia Psychicznego Biomed - Jan Latala

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: National Institute for Longevity Sciences NCGG

location_facility: Centre de Recherche Clinique du Gérontopôle Cité de la Santé

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: University of Rochester School of Medicine

location_facility: Territory Neurology & Research Institute

location_facility: Gemeinschaftspraxis für Neurologie und Psychiatrie

location_facility: Centro de Atencion Especializada (CAE) OROITU

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska

location_facility: True North Clinical Research Halifax, LLC

location_facility: Quillen College of Medicine, East TN State University

location_facility: Premiere Research Institute at Palm Beach Neurology

summary: This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.


title: This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.

ReferenceCitation: Harrison SA, Calanna S, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal A, Sejling AS, Newsome PN. Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. Contemp Clin Trials. 2020 Oct;97:106174. doi: 10.1016/j.cct.2020.106174. Epub 2020 Oct 8.

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

location_country:
Denmark
Spain
Greece
Austria
Australia
Russian Federation
Canada
Finland
United Kingdom
Sweden
Puerto Rico
United States
France
Belgium
Japan
Netherlands
Bulgaria

summary: Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis


title: Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

summary: The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Portugal
Slovenia
Sweden
Malaysia
Slovakia
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus

summary: The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

location_country:
Poland
Taiwan
Brazil
Spain
United Kingdom
Australia
Mexico
Argentina
Canada
Netherlands
Sweden
Korea, Republic of
United States
France
Malaysia
Belgium
Japan
Germany
Bulgaria


title: A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies

summary: The purpose of this study is to determine the safety and tolerability of intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).

design_allocation: Non-Randomized

lead_sponsor: Xencor, Inc.

location_country:
United States
France

location_facility: Chu Montpellier, Hematologie Clinique St. Eloi

location_facility: UVA Health System, Division of Hematology & Oncology

location_facility: Institut Paoli Calmette Dpt of Oncology/Hematology

location_facility: The Ohio State University Wexner Medical Center and James Cancer Hospital

location_facility: Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: CHU Haut-Leveque, Service d'Hematologie Clinique et Therapie Cellulaire

location_facility: Centre Hospitalier Lyon-Sud, Service d'Hematologie


acronym: POINT

intervention_type: Other

title: Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

lead_sponsor: Actelion

location_country:
Denmark
Poland
Portugal
Spain
Greece
Austria
Australia
Italy
Canada
Mexico
Russian Federation
Switzerland
United Kingdom
Hungary
United States
France
Belgium
Germany
Bulgaria
Czechia

location_facility: CHI POISSY-Saint Germay en Laye_Service de Neurologie et Réeducation

location_facility: 401 Military Hospital of Athens - Neurology Dept

location_facility: Medical Center of Athens - Neurology Dpt

location_facility: Fakultní nemocnice Hradec Králové, Neurologická klinika

location_facility: Univ of New Mexico - Health Sciences Center

location_facility: Fakultní nemocnice u sv. Anny Brno, RS Centrum

location_facility: Desarrollo Ético en Investigación Clínica S.C .

location_facility: Hospital de Santa Maria - Neurology Department

location_facility: Zentrum für klinische Forschung Dr. med. Irma Schöll

location_facility: Hospital Santa Creu I Sant Pau - Neurology Dpt

location_facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD, Neurology Clinic

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Neurologii i Oddziat Udarowy

location_facility: Aalborg Universitetshospital, Skleroseklinikken Neurologisk afdelning

location_facility: Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West (Study Center)

location_facility: Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Neurology Department 2

location_facility: Azienda Ospedaliera Universitaria Senese - Dipartimento di Scienze Neurologiche e neurosensoriali - UOSA Neurologia Sperimentale

location_facility: Hospital - Universitair Gent __Neurology Department

location_facility: Hôpital Central - CHU Nancy, Département Neurologie

location_facility: Hopital Gui de Chauliac - CHU Montpellier

location_facility: MidAmerica Neuroscience Research Foundation/Rowe Neurology

location_facility: Centro de Neurologia Avanzada, Neurology

location_facility: Hospital Santa Caterina - Neurology Department

location_facility: IRCCS NEUROMED - Istituto Neurologico Mediterraneo - Unità Operativa di Neurologia I

location_facility: Hospital of the University of Pennsylvania

location_facility: Medizinische Universität Wien, Universitätsklinik für Neurologie

location_facility: Nemocnice Jihlava, Neurologické oddělení

location_facility: Axis Heilsa S. de R.L. de C.V. (Althian)

location_facility: Neurology Associates - MS Center of Greater Orlando

location_facility: Universitätsklinikum Münster, Klinik für Allgemeine Neurologie

location_facility: Università degli Studi di Firenze - Azienda Ospedaliero Universitaria Careggi - CTO - SOD Neurologia 2

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

location_facility: State Budgetary Healthcare Institution Regional Clinical Hospital No 3

location_facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga - Centro Sclerosi Multipla CRESM

location_facility: Azienda Ospedaliera Universitaria (AOU) "Federico II" - Centro Regionale Per la Sclerosi Multipla c/o Clinica Neurologica II - Dipartimento di Scienze

location_facility: Fondazione Istituto San Raffaele , Unità Operativa di Neurologia

location_facility: CHRU de Lille - Hôpital Roger Salengro, Service de Neurologie

location_facility: Pardubicka krajska nemocnice, MS Centrum

location_facility: Moscow State Budgetary Healthcare Institution Filatov City Clinical Hospital No.15 of Moscow Health Department

location_facility: Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital

location_facility: Unidad de Investigación de Salud en Chihuahua

location_facility: "University Multiprofile Hospital for Active Treatment - Alexandrovska" EAD, Neurology Clinic

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Moscow State Budgetary Healthcare Institution Pirogov City Clinical Hospital No. 1 of Moscow Health Department

location_facility: Univeritätsspital Basel Neurologie, Neurologische Klinik und Poliklinik

location_facility: Ospedale Regionale di Lugano - Civico e Italiano, Neurologia, Lugano

location_facility: Aeginition Hospital - Neurology Department

location_facility: Neurology Assoc of Ormond Beach - CNS Trials

location_facility: Hôpital Universitaire Carémeau, Service de Neurologie

location_facility: Centro Hospitalar de São João, E.P.E. - Hospital de São João - Neurology Department

location_facility: Krajská zdravotní a.s. - Nemonice Teplice o.z., RS Centrum

location_facility: Universitätsmedizin Greifswald - Körperschaft des öffentlichen Rechts - Klinik und Poliklinik für Neurologie

location_facility: NeuroPoint GmbH, Gesellschaft für vorbeugende Gesundheitspflege

location_facility: Hospital Universitario Virgen Macarena - Neurofisiology Department

location_facility: Uzsoki utcai Kórház, Neurológiai Osztály

location_facility: NYU Langone Medical Center - MS Comprehensive Care Center

location_facility: Queen Square MS Centre / NMR research Unit UCL Institute of Neurology

location_facility: Universitätsklinikum Giessen Klinik und Poliklinik für Neurologie

location_facility: Hospital - Revalidatie & MS Centrum Overpelt_Neurology Department

location_facility: Glostrup Hospital, Neurologisk afdelning

location_facility: "Multiprofile Hospital for Active Treatment of Neurology and Psychiatry - Sveti Naum" EAD - Neurology Clinic for Movement Disorders

location_facility: Unidad de Investigacion en Salud de Chihuahua SC, Médica Sur, Unidad de Neurociencias

location_facility: AOU Università degli Studi della Campania L. Vanvitelli - I° Policlinico - DAI di Medicina Interna e Specialistica CS, Centro Sclerosi Multipla

location_facility: Azienda Ospedaliera S. Andrea di Roma - Unità Operativa Complessa di Neurologia

location_facility: Pest Megyei Flór Ferenc Kórház, Neurológia és Stroke ambulancia

location_facility: Neuro-Medic Janusz Zbrojkiewicz Poradnia Weilospecjalistyczna

location_facility: Thomas Jefferson University Hospital - Dpt Neurology MS Center

location_facility: Centre Hospitalier Sud Francilien - Service de Neurologie

location_facility: CHU de Dijon - Hôpital François Miterrand, Service de Neurologie

location_facility: WroMedica, J. Bielicka A. Strzałkowska SC

location_facility: Istituto Neurologico Carlo Besta, UOC Neurologia 4, Neuroimmunologia e Malattie Neuromuscolari, Centro Sclerosi Multipla

location_facility: Neurologische Klinik und Poliklinik - Universitätsklinikum Carl Gustav Carus, Zentrum für klinische Neurowissenschaften

location_facility: Naval Hospital of Athens - Neurology Dpt

location_facility: AOU San Martino di Genova, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DINOGMI)

location_facility: Austin Health - Neuro-Immunology Clinical Research, Education and Support Service

location_facility: Hospital universitair Brussels_neurology department

location_facility: COPERNICUS - Podmiot Leczniczy Sp. z o.o.

location_facility: Fort Wayne Neurological Center - North Office

location_facility: Medizinische Hochschule Hannover, Neurologie

location_facility: Moscow State Budgetary Healthcare Institution City Clinical Hospital No. 24 of Moscow Health Department

summary: This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).


title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

summary:
Groups 1 to 4 To estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC

Group 6 To provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced treated with cemiplimab

ReferenceCitation: Rischin D, Khushalani NI, Schmults CD, Guminski A, Chang ALS, Lewis KD, Lim AM, Hernandez-Aya L, Hughes BGM, Schadendorf D, Hauschild A, Thai AA, Stankevich E, Booth J, Yoo SY, Li S, Chen Z, Okoye E, Chen CI, Mastey V, Sasane M, Lowy I, Fury MG, Migden MR. Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. J Immunother Cancer. 2021 Aug;9(8). pii: e002757. doi: 10.1136/jitc-2021-002757.

ReferenceCitation: Paccaly AJ, Migden MR, Papadopoulos KP, Yang F, Davis JD, Rippley RK, Lowy I, Fury MG, Stankevich E, Rischin D. Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis. Adv Ther. 2021 May;38(5):2365-2378. doi: 10.1007/s12325-021-01638-5. Epub 2021 Mar 25.

ReferenceCitation: Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing. J Immunother Cancer. 2020 Jun;8(1). pii: e000775. doi: 10.1136/jitc-2020-000775.

ReferenceCitation: Migden MR, Khushalani NI, Chang ALS, Lewis KD, Schmults CD, Hernandez-Aya L, Meier F, Schadendorf D, Guminski A, Hauschild A, Wong DJ, Daniels GA, Berking C, Jankovic V, Stankevich E, Booth J, Li S, Weinreich DM, Yancopoulos GD, Lowy I, Fury MG, Rischin D. Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020 Feb;21(2):294-305. doi: 10.1016/S1470-2045(19)30728-4. Epub 2020 Jan 14.

ReferenceCitation: Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Brazil
Spain
Greece
Italy
Australia
United States
France
Germany

location_facility: Fundação Antônio Prudente - AC Camargo Câncer Center

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

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Fundação São Francisco Xavier-Hospital Márcio Cunha

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Dermatology and Laser Center of Charleston

location_facility: St. Luke's Hematology Oncology Specialists

location_facility: Andreas Sygros Hosptial-University of Athen

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Fundacion Instituto Valenciano de Oncología

location_facility: Instituto do Cancer do Estado de São Paulo ICESP

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia