title: A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer

summary:
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.

Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Guatemala
Hungary
Romania
Japan
Brazil
United States
Korea, Republic of
Spain
South Africa
Turkey
Taiwan
Peru
Ukraine
Russian Federation
France

location_facility: Osaka International Cancer Institute ( Site 3018)

location_facility: St Luke's Hospital - Kansas City ( Site 0033)

location_facility: Tokushima University Hospital ( Site 3019)

location_facility: Hospital Sao Vicente de Paulo ( Site 0311)

location_facility: Hopital Guillaume & Rene Laennec ( Site 1007)

location_facility: Hospital Juan Ramon Jimenez ( Site 1602)

location_facility: Kremenchuk Regional Oncology Center ( Site 1811)

location_facility: Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181

location_facility: Chungnam National University Hospital ( Site 2002)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2102)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 1307)

location_facility: Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)

location_facility: Medical Center Dobrobut Clinic ( Site 1808)

location_facility: Juntendo University Hospital ( Site 3011)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1110)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)

location_facility: SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 3003)

location_facility: Spitalul Municipal Ploiesti ( Site 1308)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 1108)

location_facility: Hospital Insular de Gran Canaria-Oncology ( Site 1604)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)

location_facility: HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)

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

location_facility: Semmelweis University-Pulmonológiai Klinika ( Site 1114)

location_facility: Okayama University Hospital ( Site 3012)

location_facility: Hospital Universitario Lucus Augusti ( Site 1603)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)

location_facility: Kyiv City Clinical Oncology Centre ( Site 1809)

location_facility: Spitalul Universitar de Urgenta Bucuresti ( Site 1305)

location_facility: St. Bernards Medical Center ( Site 0103)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3017)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3002)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0101)

location_facility: Kansai Medical University Hospital ( Site 3016)

location_facility: Medical Center Asklepion LLC ( Site 1804)

location_facility: Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)

location_facility: Fujita Health University Hospital ( Site 3007)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)

location_facility: Clinica Privada Dr. Rixci Ramirez ( Site 0601)

location_facility: Ukrainian Center of Tomotherapy ( Site 1807)

location_facility: Centro Regional de Sub Especialidades Médicas SA ( Site 0600)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)

location_facility: Montefiore Medical Center [Bronx, NY] ( Site 0040)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)

location_facility: Hospital Universitario La Paz ( Site 1601)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)

location_facility: Taipei Veterans General Hospital ( Site 2106)

location_facility: Clinica Internacional Sede San Borja ( Site 0705)

location_facility: The University of Tennessee Medical Center ( Site 0050)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1505)

location_facility: Marry Potter Oncology Centre ( Site 1502)

location_facility: Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)

location_facility: National Cheng Kung University Hospital ( Site 2105)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)

location_facility: St. Vincent Frontier Cancer Center ( Site 0058)

location_facility: Changhua Christian Hospital ( Site 2104)

location_facility: Tudogyogyintezet Torokbalint ( Site 1105)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0102)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1500)

location_facility: Millennium Physicians - Oncology ( Site 0097)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)

location_facility: Centre Hospitalier Sud Réunion ( Site 1020)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)

location_facility: Kanazawa University Hospital ( Site 3004)

location_facility: Cancer Blood and Specialty Clinic ( Site 0105)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 3014)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 1409)

location_facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)

location_facility: Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1003)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0700)

location_facility: Korea University Guro Hospital ( Site 2003)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)

location_facility: National Taiwan University Hospital ( Site 2101)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)

location_facility: Medical Center Mriya Med-Service ( Site 1805)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 3001)

location_facility: Steve Biko Academic Hospital ( Site 1506)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)

location_facility: PIH Health Hematology Medical Oncology ( Site 0106)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1111)

location_facility: Clínica Peruano-Americana de Trujillo ( Site 0701)


type: EudraCT Number

title: A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

summary:
The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
Switzerland
United States
Belgium
China
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: NYU Clinical Cancer Center Dept of NYU Clin CancerCenter

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd

location_facility: University Of California Los Angeles Santa Monica Location

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

summary: This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of BLU-263 + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or Part 2 will roll over onto Part 3 to receive treatment with BLU-263 in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). The study also includes PK groups that will enroll patients with ISM.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Blueprint Medicines Corporation

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

location_facility: Hôpital Necker - Départementd 'HématologieA dultes

location_facility: Dipartimentod i Oncoematologia Istituto Scientifico Romagnolop er lo studio e la cura dei tumori (IRST)- IRCCS

location_facility: CHUPorto, EPE - Hospital de Santo António

location_facility: Universitätsklinikum RWTH Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: Centro Hospitalar Universitario Sao Joao, E.P.E.

location_facility: Unita Operativa di Ematologia AOU Policlinico S. Orsola-Malpighi

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo Antonio dos Capuchos

location_facility: S.C. Ematologia Fondazione I.R.C.C.S. Policlinico San Matteo

location_facility: Hospital Virgen del Valle - Instituto de Estudios de Mastocitosis de Castilla-La Mancha

location_facility: Universitätsmedizin Mannheim III. Medizinische Klinik Universität Heidelberg Medizinische Fakultät Mannheim

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Unità Operativa di Allergologia Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Michigan Medicine University of Michigan

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: SOD Ematologia (Ambulatori)- AOUC Azienda Ospedaliero Universitaria Careggi

location_facility: Kepler Universitatsklinikum, Med Campus III. Clinic of Internal Medicine 3 - Hematology and Oncology

location_facility: S.S.D. Immunologia Clinica e Allergologia Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

location_facility: Charité - Universitätsmedizin Berlin Institute of Allergology


title: A Randomised, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of 5-grass Mix SLIT-drops in Adults With Grass Pollen-induced Rhinoconjunctivitis

acronym: Rhapsody

summary:
This is a 2 year clinical study to compare 5-grass mix SLIT-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, PGPS)

The study will collect health-related quality of life data in the groups treated with 5-grass mix SLIT-drops or with placebo during the first and second PGPS.

The trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

lead_sponsor: ALK-Abelló A/S

sponsor_collaborators:
ALK-Abelló A/S
Syneos Health

location_country: Lithuania Poland Latvia Czechia Estonia France

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Anna Latos

location_facility: Lekarze Specjaliści Malolepszy i Partnerzy

location_facility: ALL-MED. Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy. Marek Jutel.

location_facility: JSC Center for Diagnosis and Treatment of Allergic Diseases

location_facility: Snzoz Alergologia Plus Ośrodek Diagnostyki i Terapii Uczuleń

location_facility: Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

location_facility: Daugavpils Regional hospital, Outpatient clinic

location_facility: The Centre of Investigation and Treatment of Allergic Diseases

location_facility: Grażyna Jasieniak-Pinis ATOPIA NZOZ Poradnie Specjalistyczne

location_facility: Alergo-Med Specjalistycza Przychodnia Lekarska Sp. zo.o.

location_facility: NZOZ Centrum Usług Medycznych Proximum Sp. z o.o.

location_facility: Ambulance alergologie a klinicke imunologie - Ceske Budejovice

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Vevere Viktorija - Doctor's Practice in Pneumology and Allergology

location_facility: Specjalistyczna Przychodnia Alergologiczna Centrum Alergologii


title: A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors

acronym: ELEVATELung&UC

summary: The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of magrolimab in combination with docetaxel in patients with solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Gilead Sciences

location_country:
Poland
United Kingdom
United States
Spain
France

location_facility: Saint Alphonsus Cancer Institute Caldwell

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Regional Universitario de Malaga

location_facility: Instituto de Investigacion Oncologica Vall de Hebron

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Tallahassee Memorial Healthcare Cancer Center

location_facility: Centre LÃon BÃrard Centre RÃgional de Lutte Contre Le Cancer

location_facility: Comprehensive Cancer Centers of Nevada- Twain Office

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

location_facility: Institut de Cancérologie de l'Ouest (ICO) - Saint-Herblain

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Centre Antoine Lacassagne (CAL) - Site Est

location_facility: Virginia Piper Cancer Center (Alliant Health)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Wojewodzki Szpital Specjalistyczny w Siedlcach

location_facility: Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment)


acronym: The COASTAL Study

lead_sponsor: MEI Pharma, Inc.

summary: This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

sponsor_collaborators:
MEI Pharma, Inc.
Kyowa Kirin, Inc.

location_facility: Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi

location_facility: Dipartimento di Oncoematologia, Unità Linfomi, Ospedale

location_facility: UO Ematologia, Ospedale Civile S.Maria delle Croci

location_facility: Centre Hospitalier De Dunkerque - Service d'hématologie

location_facility: Országos Onkológiai Intézet Gyógyszerterápiás Központ Hematológia és Lymphoma Osztály

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Institut Catalá d'Oncologia, Hospital Duran i Reynals

location_facility: Azienda Ospedaliera Ospedali Riuniti Via Sofia

location_facility: Centre Henri Becquerel, Service d'Hematologie

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: LTD Israeli-Georgian Medical Research Clinic "Helsicore"

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Ondokuz Mayis University Medical Faculty, Hematology Department

location_facility: SOC Oncologia Medica e dei Tumori Immunocorrelati

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

location_facility: National University Corporation Tohoku University Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Albert Schweizer Ziekenhuis, Hematology Department

location_facility: Clinical Hospital Center "Zemun", Clinic for Internal Medicine, Department for Hematology

location_facility: CHU Estaing. Service d'hématologie clinique et de thérapie cellulaire adulte,

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: University Hospitals Plymouth NHS Trust, Derriford Hopital

location_facility: University General Hospital of Patras "Panagia H. Voitheia"

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: General Hospital of Athens "Laiko", Department of Haematology and Bone Marrow Transplantation

location_facility: University Clinical Center Kragujevac, Clinic for Hematology

location_facility: UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi

location_facility: Karadeniz Technical University Medical Faculty Department of Hematology

location_facility: LTD "Medinvest" Institute of Hematology and Transfusiology

location_facility: CHU de Bordeaux - Maladies Du Sang, Centre François Magendie

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Clinical Center of Vojvodina, Clinic for Hematology

location_facility: Canterbury District Health Board, Haematology Department

location_facility: J.S.C. K. Eristavi National Center of Experimental and Clinic

location_facility: Erciyes University Medical Faculty, Department of Hematology

location_facility: Gazi University Health Research and Application Hospital, Hematology Department

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

location_facility: Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology

location_facility: ARS Medical - Szpital, Oddzial hematologiczny

location_facility: UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna

location_facility: Chonnam National University Hwasun Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: University Clinical Center of Serbia, Clinic for Hematology

location_facility: University General Hospital of Ioannina, Department of Haematology

location_facility: Department of Haematology St. George's University of London

location_facility: The Oncology Institute of Hope and Innovation

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Divisione Oncoematologia, Istituto Europeo di Oncologia

location_facility: Istanbul University Istanbul Medical Faculty, Hematology Department

location_facility: UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre

location_facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie

location_facility: Zvezdara University Medical Center, Clinical department for Hematology and Oncology

location_facility: S.C. Oncoematologia Azienda Ospedaliera Santa Maria

location_facility: UOC Ematologia, Presidio Ospedaliero Papardo

location_facility: Oncology Institute of Vojvodina, Clinic for Internal Oncology

location_facility: Klinika Hematologii, Szpital Uniwersytecki

location_facility: Dunedin Hospital, Southern Blood and Cancer Service

location_facility: U.O. Ematologia, Azienda Ospedaliera S. Croce e Carle

status: Terminated

title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study

source: euctr

study_completion_date_type: Actual

location_country:
Poland
New Zealand
Australia
Japan
Turkey
Canada
Serbia
France
Hungary
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Georgia

status_simplified: Unknown


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)

summary: This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

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).

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Poland
Australia
Brazil
Turkey
Croatia
Canada
France
Slovenia
Colombia
Portugal
United States
China
Philippines
Italy
Norway
United Kingdom
Korea, Republic of
Spain
Greece
Russian Federation

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center

location_facility: The Second Affiliated Hospital, Zhejiang University

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: University General Hospital of Heraklion;Internal Medicine-Oncology Clinic

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Centre Hospitalier de l?Université de Montréal (CHUM)

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

location_facility: Acibadem University School of Medicine Altunizade Hospital Oncology Service

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

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

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi

location_facility: Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors

location_facility: State Healthcare Institution ?Regional Clinical Oncology Dispensary?

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: FSBSI ?N. N. Blokhin Russian Cancer Research Center?

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: St. Luke's Medical Center; Human Cancer Biobank Research Center

location_facility: CHUS (Centre Hospitalier Universitaire de Sherbrooke)

location_facility: Hospital Universitario Quiron Madrid; Servicio de Oncologia

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

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team

location_facility: Helsinki University Central Hospital; Dept of Oncology

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

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Cebu Doctors' University Hospital; Research Office

location_facility: Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Harbin Medical University Cancer Hospital

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

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

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: St. Petersburg Clinical Scientific Center of special services medical assis (oncology)

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

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Zhejiang Provincial People's Hospital; Oncology& Breast

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: Oslo Universitetssykehus HF; Ullevål sykehus

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly)

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: IPO de Lisboa; Servico de Oncologia Medica


type: Other Identifier

type: Registry Identifier

title: An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

summary:
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).

The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_country:
Finland
Germany
Ireland
Poland
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Colombia
Hungary
Denmark
United States
Ukraine
Romania
China
Malaysia
Philippines
Italy
Guatemala
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden

location_facility: Soerlandet sykehus HF Kristiansand ( Site 2007)

location_facility: Sapporo Medical University Hospital ( Site 5008)

location_facility: The First Hospital of Jiaxing ( Site 6033)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1414)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 2615)

location_facility: Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)

location_facility: Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)

location_facility: HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)

location_facility: Cancercare Rondebosch Oncology ( Site 3005)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 2412)

location_facility: National Taiwan University Hospital ( Site 4401)

location_facility: Tianjin Medical University Cancer Institute and Hospital ( Site 6029)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 1203)

location_facility: Oncólogos del Occidente S.A ( Site 0501)

location_facility: Universiti Malaya Medical Centre ( Site 4300)

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

location_facility: Norrlands Universitetssjukhus ( Site 2106)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2903)

location_facility: Kyiv City Clinical Oncology Center ( Site 2706)

location_facility: Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)

location_facility: Hospital Clinico San Carlos ( Site 1503)

location_facility: Helios Kliniken Schwerin GmbH ( Site 1302)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 3000)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0019)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0308)

location_facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 2202)

location_facility: Vanderbilt University Medical Center ( Site 0069)

location_facility: Instituto Nacional de Cancerologia ( Site 0602)

location_facility: Regional Oncology Center of Kharkiv ( Site 2708)

location_facility: Fundacion Arturo Lopez Perez ( Site 0400)

location_facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)

location_facility: Fakultni Thomayerova nemocnice ( Site 2201)

location_facility: Hamamatsu University School of Medicine University Hospital ( Site 5004)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 1411)

location_facility: Oregon Health & Science University ( Site 0071)

location_facility: Instituto Nacional de Cancerología E.S.E. ( Site 0503)

location_facility: Rush University Medical Center ( Site 0040)

location_facility: Dana Farber Cancer Institute ( Site 0093)

location_facility: The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)

location_facility: Ankara Universitesi Tip Fakultesi ( Site 2902)

location_facility: New England Cancer Specialists ( Site 0082)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1504)

location_facility: FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)

location_facility: Emory University Winship Cancer Institute ( Site 0012)

location_facility: Universitaetsklinik fuer Urologie ( Site 1300)

location_facility: Hokkaido University Hospital ( Site 5013)

location_facility: Massachusetts General Hospital ( Site 0094)

location_facility: Cardinal Santos Medical Center ( Site 4603)

location_facility: Administradora Country SA - Clinica del Country ( Site 0504)

location_facility: Okayama University Hospital ( Site 5017)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2420)

location_facility: Cedars Sinai Medical Center ( Site 0027)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)

location_facility: Centro Investigacion Cancer James Lind ( Site 0402)

location_facility: Spitalul Judetean de Urgenta Alba Iulia ( Site 2502)

location_facility: Seoul National University Hospital ( Site 4201)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 0702)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1417)

location_facility: Tokyo Medical And Dental University Medical Hospital-Urology ( Site 5009)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2704)

location_facility: Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)

location_facility: BC Cancer - Vancouver Center ( Site 0120)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)

location_facility: Guangzhou First People's Hospital ( Site 6007)

location_facility: Tokyo Women's Medical University Adachi Medical Center ( Site 5023)

location_facility: Akershus universitetssykehus ( Site 2000)

location_facility: Vaal Triangle Oncology Centre ( Site 3010)

location_facility: University Cancer & Blood Center, LLC ( Site 0057)

location_facility: Beth Israel Deaconess Medical Center ( Site 0089)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)

location_facility: Ningbo First Hospital-Urology ( Site 6028)

location_facility: Klinički Bolnički Centar Split ( Site 3202)

location_facility: West China Hospital Sichuan University-Urology Surgery ( Site 6016)

location_facility: Institut Català d'Oncologia (ICO) - Girona ( Site 1500)

location_facility: Orszagos Onkologiai Intezet ( Site 2304)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0018)

location_facility: Institut za onkologiju Vojvodine ( Site 3311)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1501)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0704)

location_facility: Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)

location_facility: University of California Irvine ( Site 0029)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1412)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Nara Medical University Hospital ( Site 5002)

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 2300)

location_facility: The Second Hospital of Tianjin Medical University ( Site 6032)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0506)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 3006)

location_facility: UCLA Hematology Oncology Santa Monica ( Site 0048)

location_facility: Korea University Anam Hospital ( Site 4206)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

location_facility: Advent Health Hematology & Oncology ( Site 0003)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1301)

location_facility: Xiangya Hospital Central South University ( Site 6034)

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)

location_facility: The First Affiliated hospital of Xiamen University-Urology ( Site 6001)

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1404)

location_facility: Shanghai Tenth People's Hospital ( Site 6023)

location_facility: Tallaght University Hospital ( Site 6100)

location_facility: Kuopion Yliopistollinen Sairaala ( Site 1803)

location_facility: Roswell Park Cancer Institute ( Site 0032)

location_facility: Tokushima University Hospital-Department of Urology ( Site 5019)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)

location_facility: Chungnam National University Hospital ( Site 4205)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)

location_facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)

location_facility: Sunnybrook Research Institute ( Site 0116)

location_facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)

location_facility: Jiangxi Provincial Cancer Hospital ( Site 6042)

location_facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 2102)

location_facility: Taipei Veterans General Hospital ( Site 4402)

location_facility: Niigata University Medical & Dental Hospital ( Site 5024)

location_facility: The First Affiliated Hospital, Zhejiang University ( Site 6024)

location_facility: City clinical oncological dispensary ( Site 2605)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1502)

location_facility: The University of Alabama at Birmingham ( Site 0010)

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)

location_facility: Clinical oncology dispensary of Dnipro ( Site 2700)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 4406)

location_facility: The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 4302)

location_facility: Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)

location_facility: Taichung Veterans General Hospital ( Site 4403)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 2709)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0065)

location_facility: Dartmouth Hitchcock Medical Center ( Site 0075)

location_facility: Saitama Medical University International Medical Center ( Site 5015)

location_facility: Henan Cancer Hospital-Urology ( Site 6006)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)

location_facility: Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)

location_facility: Lviv State Regional Oncological Center ( Site 2712)

location_facility: Hospital H+ Queretaro-Cuidados Oncológicos ( Site 0608)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2100)

location_facility: ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2710)

location_facility: Lahey Hospital & Medical Center ( Site 0090)

location_facility: Azienda Ospedaliera S. Maria di Terni ( Site 1410)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1409)

location_facility: Centro Medico Integral de Cancerologia CEMIC ( Site 0701)

location_facility: Altay Regional Oncology Dispensary ( Site 2610)

location_facility: Hospital Universitario 12 de Octubre ( Site 1505)

location_facility: Fakultni nemocnice u sv. Anny v Brne ( Site 2205)

location_facility: Nippon Medical School Hospital ( Site 5006)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2501)

location_facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 3001)

location_facility: National Cancer Center Hospital East ( Site 5000)

location_facility: Centro de Pesquisas Clinicas em Oncologia ( Site 0306)

location_facility: Peking University First Hospital ( Site 6011)

location_facility: Masarykuv onkologicky ustav ( Site 2203)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0605)

location_facility: National Cheng Kung University Hospital ( Site 4404)

location_facility: The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 6041)

location_facility: Severance Hospital Yonsei University Health System ( Site 4204)

location_facility: Markusovszky Egyetemi Oktatokorhaz ( Site 2303)

location_facility: Chongqing University Cancer Hospital ( Site 6009)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0310)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2001)

location_facility: Sykehuset Østfold HF Kalnes ( Site 2003)

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 3116)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)

location_facility: The Loginov Moscow Clinical Scientific Center ( Site 2604)

location_facility: Harbin Medical University Cancer Hospital-urology ( Site 6015)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3200)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)

location_facility: Moscow Oncological Clinical Dispensary #1 ( Site 2619)

location_facility: Radomskie Centrum Onkologii ( Site 2418)

location_facility: Clinique Ambroise Pare Beuvry ( Site 1213)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2406)

location_facility: University of Mississippi Medical Center ( Site 0037)

location_facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)

location_facility: R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 6019)


title: A Phase 2, Multicenter, Randomized Study to Compare the Efficacy and Safety of MK-7684A or MK-7684A Plus Docetaxel Versus Docetaxel Monotherapy in the Treatment of Participants With Metastatic Non-small Cell Lung Cancer With Progressive Disease After Treatment With a Platinum Doublet Chemotherapy and Immunotherapy

summary: The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Thailand
France
Denmark
Switzerland
United States
Belgium
Malaysia
Italy
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Centro de Oncología e Investigación de Buenos Aires ( Site 0008)

location_facility: Mackay Memorial Hospital-Chest Medicine ( Site 2305)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303)

location_facility: Central Clinical Hospital of the Presidential Administrative Department ( Site 1902)

location_facility: Taichung Veterans General Hospital-Chest ( Site 2307)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0001)

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006)

location_facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005)

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1305)

location_facility: Gold Coast University Hospital-Clinical Trials Service ( Site 0106)

location_facility: Moscow Clinical Research Center-Chemotherapy department ( Site 1910)

location_facility: NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302)

location_facility: Helios Dr. Horst Schmidt Kliniken ( Site 1108)

location_facility: Rambam Health Care Campus-Oncology ( Site 1203)

location_facility: Mercy Research - David C. Pratt Cancer Center ( Site 2532)

location_facility: University Malaya Medical Centre ( Site 1501)

location_facility: Hadassah Medical-Oncology department ( Site 1912)

location_facility: N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

location_facility: Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 2303)

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009)

location_facility: Hospital Privado de Comunidad ( Site 0004)

location_facility: Instituto de Oncología de Rosario ( Site 0003)

location_facility: Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705)

location_facility: Ospedale Regionale Bellinzona e Valli ( Site 2203)

location_facility: Asan Medical Center-Oncology ( Site 2000)

location_facility: National Taiwan University Hospital-Oncology ( Site 2304)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101)

location_facility: Oulun yliopistollinen sairaala ( Site 0902)

location_facility: Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 1206)

location_facility: Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

location_facility: Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905)

location_facility: St Francis Cancer Center-Research Office ( Site 2531)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908)

location_facility: Hospital Nossa Senhora da Conceição ( Site 0403)

location_facility: Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 2511)

location_facility: Medizinische Universität Graz ( Site 0201)

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300)

location_facility: Cedars-Sinai Medical Center ( Site 2522)

location_facility: Odense Universitetshospital ( Site 0700)

location_facility: Klinikverbund Allgaeu gGmbH ( Site 1109)

location_facility: Mercy Research - Cancer and Hematology Center ( Site 2535)

location_facility: Tampereen yliopistollinen sairaala-Oncology ( Site 0906)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005)

location_facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526)

location_facility: Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909)

location_facility: Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004)

location_facility: Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 2400)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002)

location_facility: Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338)

location_facility: Hospital Tengku Ampuan Afzan ( Site 1500)

location_facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400)

location_facility: Fiona Stanley Hospital-Medical Oncology ( Site 0102)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

location_facility: Baptist Health Lexington-Research ( Site 2502)

location_facility: Seoul National University Bundang Hospital ( Site 2003)

location_facility: Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204)

location_facility: Chungbuk National University Hospital-Internal medicine ( Site 2004)

location_facility: Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102)

location_facility: GBUZ LOKB-Oncology department #1 ( Site 1905)

location_facility: Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103)

location_facility: AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333)

location_facility: Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337)

location_facility: CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008)

location_facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307)


lead_sponsor: Bayer

summary:
Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.

There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.

During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.

sponsor_collaborators:
Bayer
Merck Sharp & Dohme LLC

location_facility: University of California Irvine Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Japanese Red Cross Society Musashino Red Cross Hospital

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital General Universitario Gregorio Marañón | Digestivo

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Klinikum der Universität München Grosshadern

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: University of Miami Miller School of Medicine

location_facility: H. Lee Moffitt Cancer Center & Research Institute

title: An Open-Label Study of Regorafenib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC) After PD1/PD-L1 Immune Checkpoint Inhibitors

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Germany
Italy
France
Japan
United States
Korea, Republic of
Spain
Israel


acronym: Autonomy

lead_sponsor: Janssen Research & Development, LLC

summary: The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.

location_facility: University of South Florida - Health Byrd Alzheimer Institute

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Cleveland Clinic Lou Revo Center for Brain Health

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Kobe City Medical Center General Hospital

location_facility: University of California San Diego Medical Center

location_facility: Anil Nair dba Alzheimer's Disease Center

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: The University of Texas Health Science Center at Houston

location_facility: National Center For Geriatrics And Gerontology

location_facility: Washington University School of Medicine

location_facility: Palm Beach Neurology and Premier Research Institute

location_facility: Rijikai Medical Corporation Katayama Medical Clinic

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Alzheimers Research and Treatment Center

location_facility: HammondCare Neurodegenerative Clinical Trials - VIC

location_facility: Neuropsychiatric Research Center of SWFL

location_facility: Australian Alzheimer's Research Foundation Incorporated

location_facility: Advanced Memory Research Institute of NJ

location_facility: Alexian Brothers Medical Center - Neuroscience Research Institute

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
United Kingdom
Australia
Japan
Netherlands
Sweden
Belgium
United States
Spain
Canada
France


title: Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs

acronym: CHANCE

summary: Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solis-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepcion M, Cordoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Gines P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29.

ReferenceCitation: Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. 2017 Oct;67(4):708-715. doi: 10.1016/j.jhep.2017.06.009. Epub 2017 Jun 21.

ReferenceCitation: Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18.

lead_sponsor: European Foundation for Study of Chronic Liver Failure

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Switzerland
United States
India
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery

location_facility: Mahatma Gandhi University of Medical Sciences and Technology

location_facility: Hautepièrre Hospital, Service de Réanimation Médicale

location_facility: Baylor College of Medicine (Scott & White)

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: S.Orsola Hospital - Alma Mater Studiorum University of Bologna

location_facility: Auckland City Hospital- New Zealand Liver Transplant Unit

location_facility: University Medical Center, Hamburg Eppendorf

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: University of Toronto, Multiorgan Transplant Program

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: Inonu University, Liver Transplantation Institute

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: Hospital das Clínicas da Universidade de São Paulo

location_facility: Scottish Liver Transplant Unit, Royal Infirmary

location_facility: University of Maryland School of Medicine

location_facility: Global Hospital. Super speciality & transplant centre

location_facility: University Medical Center Groningen (UMCG)

location_facility: Queen Mary Hospital, The University of Hong Kong

location_facility: Medical University of Vienna, Department of Transplant Surgery

location_facility: APHP Hôpitaux Universitaires Pitié Salpêtrière

intervention_type: Other


acronym: Phase 3 Study of MK-6482 in Combination With Lenvatinib Versus Cabozantinib for Treatment of RCC

summary:
This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.

The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

location_facility: Tulane University School of Medicine ( Site 0098)

location_facility: Yokohama City University Hospital ( Site 5007)

location_facility: Amphia Hospital Location Molengracht ( Site 1912)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201)

location_facility: FSBI United Hospital with Polyclinic ( Site 2613)

location_facility: Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)

location_facility: Tokyo Women's Medical University Adachi Medical Center ( Site 5015)

location_facility: Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)

location_facility: St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)

location_facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311)

location_facility: HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)

location_facility: Ironwood Cancer & Research Centers ( Site 0077)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 0402)

location_facility: Cancer Partners of Nebraska ( Site 0086)

location_facility: Instituto Alexander Fleming ( Site 0800)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200)

location_facility: Ospedale Maggiore Borgo Trento ( Site 1408)

location_facility: Providence Saint John's Health Center ( Site 0083)

location_facility: Nemocnice České Budějovice-Onkologicke oddeleni ( Site 2204)

location_facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 1314)

location_facility: Medizinische Universität Wien ( Site 1021)

location_facility: Helios Klinikum Erfurt GmbH ( Site 1315)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501)

location_facility: Toho University Sakura Medical Center ( Site 5014)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 1209)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)

location_facility: NCT-Department of Medical Oncology ( Site 1320)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 1402)

location_facility: Hamamatsu University School of Medicine University Hospital ( Site 5004)

location_facility: Mater Private Hospital - Dublin ( Site 3202)

location_facility: Niigata University Medical & Dental Hospital ( Site 5013)

location_facility: Rush University Medical Center ( Site 0040)

location_facility: Southend University Hospital ( Site 3112)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)

location_facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1406)

location_facility: Hospital Clinic i Provincial ( Site 1500)

location_facility: Cedars Sinai Medical Center ( Site 0027)

location_facility: Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)

location_facility: University of Mississippi Medical Ctr ( Site 0037)

location_facility: Hospital Británico de Buenos Aires-Oncology ( Site 0801)

location_facility: Kobe City Medical Center General Hospital ( Site 5017)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0055)

location_facility: Tallaght University Hospital ( Site 3200)

location_facility: Sanatorio Británico-Clinical Oncology Department ( Site 0802)

location_facility: Azienda Ospedaliera S. Maria di Terni ( Site 1401)

location_facility: University of Vermont Medical Center ( Site 0001)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)

location_facility: Complejo Hospitalario Universitario A Coruna ( Site 1502)

location_facility: Tokyo Medical and Dental University Hospital ( Site 5009)

location_facility: Universitaetsklinikum Frankfurt ( Site 1301)

location_facility: Chonnam National University Hwasun Hospital-Oncology ( Site 4203)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0313)

location_facility: University Cancer & Blood Center, LLC ( Site 0057)

location_facility: Fundación Cardiovascular de Colombia ( Site 0501)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003)

location_facility: Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)

location_facility: Hospital Clinico San Carlos ( Site 1504)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500)

location_facility: Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)

location_facility: Osaka International Cancer Institute ( Site 5016)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0018)

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)

location_facility: Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001)

location_facility: Medizinische Universitätsklinik Graz ( Site 1051)

location_facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407)

location_facility: Universitaetsklinikum des Saarlandes ( Site 1305)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)

location_facility: Nara Medical University Hospital ( Site 5002)

location_facility: Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200)

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010)

location_facility: Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0078)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240

location_facility: Georgetown University Medical Center ( Site 0006)

location_facility: Peninsula Health Frankston Hospital ( Site 4001)

location_facility: Hospital Santa Creu i Sant Pau ( Site 1501)

location_facility: Mater Misericordiae University Hospital ( Site 3201)

location_facility: Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1505)

location_facility: Universitaetsklinikum Aachen AOER ( Site 1317)

location_facility: Kingston Health Sciences Centre ( Site 0105)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0065)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 2616)

location_facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)

location_facility: CISSS de la Monteregie-Centre ( Site 0103)

location_facility: HELIOS Klinikum Berlin-Buch ( Site 1311)

location_facility: Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)

location_facility: IRCCS Ospedale San Raffaele ( Site 1409)

location_facility: Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113)

location_facility: Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105)

location_facility: SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)

location_facility: Universitair Medisch Centrum Utrecht ( Site 1910)

location_facility: Lahey Hospital & Medical Center ( Site 0090)

location_facility: Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)

location_facility: European Interbalkan Medical Center-Oncology Department ( Site 3300)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218)

location_facility: The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116)

location_facility: Nippon Medical School Hospital ( Site 5006)

location_facility: University of Texas, Southwestern Medical Center ( Site 0015)

location_facility: Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)

location_facility: Royal United Hospital Bath England ( Site 3108)

location_facility: Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010)

location_facility: Centro Gaucho Integrado de Oncologia ( Site 0304)

location_facility: National Cancer Center Hospital East ( Site 5000)

location_facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0048)

location_facility: Hadassah Medical-Oncology department ( Site 2609)

location_facility: Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106)

location_facility: Blue Ridge Cancer Care - Roanoke ( Site 0043)

location_facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)

location_facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)

location_facility: Universitaetsspital Zuerich ( Site 1601)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 0505)

location_facility: Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)

location_facility: Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410)

location_facility: Medical Oncology Ospedale San Donato ( Site 1404)

location_facility: Volgograd Regional Uronephrological Center ( Site 2615)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0308)

location_facility: UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507)

location_facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201)

location_facility: Centrul de Oncologie "Sfântul Nectarie" ( Site 2502)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1602)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)

location_facility: Istituti Clinici Scientifici Maugeri Spa ( Site 1403)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1321)

location_facility: Sapporo Medical University Hospital ( Site 5008)

location_facility: R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)

location_facility: Tampereen yliopistollinen sairaala ( Site 1801)

title: An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

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


acronym: PAPILLON

summary: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tianjin Medical University General Hospital

location_facility: The First Affiliated Hospital Zhejiang University College of Medicine

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: Kobe City Medical Center General Hospital

location_facility: Peking University International Hospital

location_facility: Fujian Medical University Union Hospital

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Shengjing Hospital of China Medical University

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Başkent University Medical Faculty Adana Application and Research Center

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: Nizhny Novgorod Regional Oncological Dispensary

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Saitama Medical University International Medical Center

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Centro Hospitalar de Vila Nova de Gaia Espinho E P E

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

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

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Yaroslavl Regional Clinical Oncology Hospital

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

location_facility: The First People's Hospital Of Changzhou

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Songklanagarind Hospital, Prince of Songkla University

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

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Harbin medical university cancer hospital

location_facility: Beijing Chest hospital, Capital medical university

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

title: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Portugal
Hungary
United States
Ukraine
India
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants.

summary:
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only.

Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms.

The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Poland
Slovakia
Hungary
Argentina
Australia
Japan
United States
Spain
Czechia
Bulgaria
Canada
Russian Federation
France

location_facility: CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinic

location_facility: Mental Health Center "Prof. Dr. Ivan Temkov - Burgas" EOOD

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: The Ohio State University Wexner Medical Center

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

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Centre for Addiction and Mental Health (CAMH)

location_facility: Braxia Scientific Corp. (CRTCE Mississauga)

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Specialist Psychiatric Healthcare Centre in Lodz

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: Global Medical Institutes, LLC, Scranton Medical Institute

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Federal State Budget Institution "Mental Health Research Center"

location_facility: Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: University of Kansas School of Medicine-Wichita

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: FSBEI of HE Smolensk State Medical University

location_facility: SBHI "Psychiatric Hospital #1 P.P.Kashchenko"

location_facility: Pro mente sana s.r.o., Psychiatric clinic

location_facility: Praxis für Psychiatrie und Psychotherapie

location_facility: SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"

location_facility: National Center of Neurology and Psychiatry

location_facility: FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro

location_facility: "Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry

location_facility: SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"

location_facility: Collaborative Neuroscience Research, LLC

location_facility: Peninsula Therapeutic and Research Group

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: CENPIA-Centro de Estudios Neuropsiquiátricos y Psicológicos Integral Ambulatorio

location_facility: National Center for Global Health and Medicine Kohnodai Hospital

location_facility: Monash Alfred Psychiatry Research Centre