ReferenceCitation: Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.

name: Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA

family: Sax

full_name: Paul E Sax

given: Paul E

family: Rockstroh

full_name: Jürgen K Rockstroh

given: Jürgen K

name: University of California, San Francisco, San Francisco, California, USA

family: Luetkemeyer

full_name: Anne F Luetkemeyer

given: Anne F

name: Hôpital Bichat Claude Bernard, Paris, France

family: Yazdanpanah

full_name: Yazdan Yazdanpanah

given: Yazdan

name: Dupont Circle Physicians, Washington, District of Columbia, USA

family: Ward

full_name: Douglas Ward

given: Douglas

name: Clinique de Medecine Urbaine du Quartier Latin, Montreal, Quebec, Canada

family: Trottier

full_name: Benoit Trottier

given: Benoit

name: University of Vienna Medical School, Vienna, Austria

family: Rieger

full_name: Armin Rieger

given: Armin

name: Gilead Sciences, Foster City, California, USA

family: Liu

full_name: Hui Liu

given: Hui

family: Acosta

full_name: Rima Acosta

given: Rima

full_name: Sean E Collins

given: Sean E

family: Brainard

full_name: Diana M Brainard

given: Diana M

family: Martin

full_name: Hal Martin

given: Hal

journal_name: Clinical Infectious Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

lead_sponsor: Gilead Sciences

location_country:
Austria
Germany
France
Puerto Rico
United States
Canada

location_facility: AIDS Healthcare Foundation - South Beach

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie

location_facility: Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: Hepatitis/HIV Clinical Trials Group (HHCTG)

location_facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Providence Hospital Center for Infectious Diseases

location_facility: Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I

location_facility: Kaiser Permanente, Department of Infectious Diseases

location_facility: Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: University of Miami Divison of Infectious Diseases Clinical Research Unit

location_facility: Palmetto Health Richland (Regulatory and Study Supply Shipping)

location_facility: AIDS Arms Inc/ Trinity Health and Wellness Center

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

location_facility: Chronical Viral Illness Service/McGill University Health Care (MUHC)

location_facility: Hennepin County Medical Center, Positive Care Clinic

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Instituto de Investigacion Cientifica del Sur

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: Mercer University, Department of Internal Medicine

location_facility: Abbott Northwestern Hospital part of Allina Health

location_facility: John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

location_facility: Clinique de Médecine Urbaine du Quartier Latin

location_facility: Community Research Initiative of New England

location_facility: EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Medical University of South Carolina (MUSC)

location_facility: Maple Leaf Research / Maple Leaf Medical Clinic

location_facility: MultiCare Rockwood HIV Critical Care Clinic

location_facility: Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie

location_facility: Infectious Disease Research Institute Inc

location_facility: Highland Hospital - Alameda Health System

location_facility: East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Hôpital Gui de Chauliac, CHU de Montpellier

location_facility: Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz

location_facility: Claudia T Martorell, MD., LLC d/b/a The Research Institute

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.


title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

summary:
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Yun MR, Kim DH, Kim SY, Joo HS, Lee YW, Choi HM, Park CW, Heo SG, Kang HN, Lee SS, Schoenfeld AJ, Drilon A, Kang SG, Shim HS, Hong MH, Cui JJ, Kim HR, Cho BC. Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naïve and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Jul 1;26(13):3287-3295. doi: 10.1158/1078-0432.CCR-19-2777. Epub 2020 Apr 8.

family: Yun

full_name: Mi Ran Yun

given: Mi Ran

sequence: first

family: Kim

full_name: Dong Hwi Kim

given: Dong Hwi

sequence: additional

full_name: Seok-Young Kim

given: Seok-Young

family: Joo

full_name: Hyeong-Seok Joo

given: Hyeong-Seok

family: Lee

full_name: You Won Lee

given: You Won

family: Choi

full_name: Hun Mi Choi

given: Hun Mi

family: Park

full_name: Chae Won Park

given: Chae Won

family: Heo

full_name: Seong Gu Heo

given: Seong Gu

family: Kang

full_name: Han Na Kang

given: Han Na

full_name: Sung Sook Lee

given: Sung Sook

family: Schoenfeld

full_name: Adam J. Schoenfeld

given: Adam J.

family: Drilon

full_name: Alexander Drilon

given: Alexander

full_name: Seok-Gu Kang

given: Seok-Gu

family: Shim

full_name: Hyo Sup Shim

given: Hyo Sup

family: Hong

full_name: Min Hee Hong

given: Min Hee

family: Cui

full_name: J. Jean Cui

given: J. Jean

full_name: Hye Ryun Kim

given: Hye Ryun

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Association for Cancer Research (AACR)

publisher_dissemination: American Association for Cancer Research

publisher_group: American Association for Cancer Research

publisher_normalized: American Association for Cancer Research

title: Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naïve and Solvent-Front–Mutant ROS1-Rearranged Non–Small Cell Lung Cancer

ReferenceCitation: Drilon A, Ou SI, Cho BC, Kim DW, Lee J, Lin JJ, Zhu VW, Ahn MJ, Camidge DR, Nguyen J, Zhai D, Deng W, Huang Z, Rogers E, Liu J, Whitten J, Lim JK, Stopatschinskaja S, Hyman DM, Doebele RC, Cui JJ, Shaw AT. Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations. Cancer Discov. 2018 Oct;8(10):1227-1236. doi: 10.1158/2159-8290.CD-18-0484. Epub 2018 Aug 9.

family: Ou

full_name: Sai-Hong Ignatius Ou

given: Sai-Hong Ignatius

ipd_sharing_description: There are no plans to share individual participant data with other researchers.

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

location_facility: Hong Kong United Oncology Centre PHASE 2

location_facility: Cancer Specialists of North Florida PHASE 2

location_facility: Fort Wayne Medical Oncology and Hematology PHASE 2

location_facility: Beijing Cancer Hospital/Oncology Department PHASE 2

location_facility: Hematology Oncology Associates of Fredericksburg PHASE 2

location_facility: Hospital Universitario Dexeus - Grupo Quironsalud PHASE 2

location_facility: Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department PHASE 2

location_facility: Vall d'Hebron University Hospital PHASE 2

location_facility: National Cancer Center Singapore PHASE 2

location_facility: Seoul National University Hospital PHASE 2

location_facility: The Center for Cancer & Blood Disorders - Maryland PHASE 2

location_facility: Princess Margaret Cancer Center at University Health Network PHASE 2

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cerevello" PHASE 2

location_facility: Centre Hospitalier Regional Vuniversitaire Brest PHASE 2

location_facility: Chonnam National University Hwasun Hospital PHASE 2

location_facility: The Christie NHS Foundation Trust PHASE 2

location_facility: National Taiwan University Hospital PHASE 2

location_facility: Weifang People's Hospital/Medical Oncology Department PHASE 2

location_facility: Evangelische Lungenklinik Berlin PHASE 2

location_facility: Cancer Hospital Chinese Academy of Medical Sciences/Cancer Institute PHASE 2

location_facility: University Clinic Carl Gustav Carus PHASE 2

location_facility: Guangdong Provincial People's Hospital PHASE 2

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico PHASE 2

location_facility: UZA Research Unit Oncology- route 55 PHASE 2

location_facility: Fujian Provincial Cancer Hospital/Thoracic oncology Department PHASE 2

location_facility: Henan Cancer Hospital/The 1st pneumology department PHASE 2

location_facility: UC San Diego Moores Cancer Center PHASE 2

location_facility: Georgetown Lombardi Comprehensive Cancer Center PHASE 2

location_facility: The First Affiliated Hospital Zhejiang University School of Medicine/Respiratory medicine Department PHASE 2

location_facility: Massachusetts General Hospital PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii PHASE 2

location_facility: The Affiliated Tumor Hospital of Harbin Medical University/Medical Oncology Department PHASE 2

location_facility: Anhui Provincial Hospital/Oncology Department PHASE 2

location_facility: Shanghai Chest Hospital/Chest Cancer Institute PHASE 2

location_facility: Ventura County Hematology Oncology Specialists PHASE 2

location_facility: Memorial Sloan Kettering Cancer Center PHASE 1 (recruiting) & PHASE 2 (Recruiting)

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine/Oncology Department PHASE 2

location_facility: Ohio State Wexner Medical Center PHASE 2

location_facility: MD Anderson Cancer Center - The University of Texas PHASE 2

location_facility: Avera Cancer Institute Center for Precision Oncology PHASE 2

location_facility: Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center PHASE 2

location_facility: Hunan Cancer Hospital/Medical Oncology Department PHASE 2

location_facility: Oklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) PHASE 2

location_facility: The Second XIANGYA Hospital Of Central South University/Oncology Department PHASE 2

location_facility: The Royal Marsden NHS Foundation Trust PHASE 2

location_facility: University of Michigan Rogel Cancer Center PHASE 2

location_facility: Regions Hospital Cancer Care Center PHASE 2

location_facility: Centrum für Integrierte Onkologie - Universitaetsklinikum Koeln PHASE 2

location_facility: The First Affiliated Hospital of Xiamen University/Medical oncology Department PHASE 2

location_facility: The First Affiliated Hospital of Gannan Medical University PHASE 2

location_facility: Konkuk University Medical Center PHASE 2

location_facility: Katedra i Klinika Pneumonologii, Onkologii i Alergologii Uniwersytetu Medycznego w Lublinie PHASE 2

location_facility: University of Maryland School of Medicine PHASE 2

location_facility: Frederick Health - James M Stockman Cancer Institute PHASE 2

location_facility: The First Hospital of Jilin University/Oncology Center Department PHASE 2

location_facility: Jinan Central Hospital/Medical Oncology Department PHASE 2

location_facility: MGH Satellite - Dana-Farber Cancer Institute PHASE 2

location_facility: Azienda Ospedaliera Santa Maria di Terni - PHASE 2

location_facility: Columbus Regional Research Institute PHASE 2

location_facility: UC Irvine Health, Chao Family Comprehensive Cancer Center PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: Yonsei Cancer Center, Severance Hospital PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: University Cancer and Blood Center PHASE 2

location_facility: Imperial College London - Hammersmith Hospital PHASE 2

location_facility: Shanghai Chest Hospital/Oncology Department PHASE 2

location_facility: Rigshospitalet, University Hospital of Copenhagen PHASE 2

location_facility: Universiair Medisch Centrum Groningen PHASE 2

location_facility: Centre Hospitalier Universitarie Arie Grenoble Alpes (CHUGA) PHASE 2

location_facility: New Jersey Cancer Care and Blood Disorders PHASE 2

location_facility: Instituto Valenciano de Oncología PHASE 2

location_facility: Pontchartrain Cancer Center (QCCA) PHASE 2

location_facility: Washington University Siteman Cancer Center PHASE 2

location_facility: University of Colorado Denver PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: Johns Hopkins Kimmel Cancer Center PHASE 2

location_facility: West China Hospital Sichuan University/Lung cancer center PHASE 2

location_facility: XuZhou Central Hospital/Oncology Department PHASE 2

location_facility: IRCCS Istituto Regina Elena Oncologia Medica 1 PHASE 2

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori PHASE 2

location_facility: Hopital D'Instruction Des Armees Begin PHASE 2

location_facility: Sichuan Cancer Hospital/Medical Oncology Department PHASE 2

location_facility: The first Hospital Affiliated to AMU (Southwest Hospital)/Pneumology Department PHASE 2

location_facility: Seoul National University Hospital PHASE 1 (recruiting) and PHASE 2 (not yet recruiting)

location_facility: Jilin Cancer Hospital/Medical Oncology Department PHASE 2

location_facility: The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine PHASE 2

location_facility: Hospital Universitario 12 de Octubre PHASE 2

location_facility: Zhejiang Cancer Hospital/Thoracic Oncology Department PHASE 2

location_facility: Maria Sklodowska-Curie Cancer Centre and Institute PHASE 2

location_facility: National Cheng Kung University Hospital PHASE 2

location_facility: Chungbuk National University Hospital PHASE 2


type: EudraCT Number

type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

acronym: ECLIPSE

summary: The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

ReferenceCitation: Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8.

family: Reich

full_name: Kristian Reich

given: Kristian

family: Armstrong

full_name: April W Armstrong

given: April W

family: Langley

full_name: Richard G Langley

given: Richard G

family: Flavin

full_name: Susan Flavin

given: Susan

family: Randazzo

full_name: Bruce Randazzo

given: Bruce

family: Li

full_name: Shu Li

given: Shu

family: Hsu

full_name: Ming-Chun Hsu

given: Ming-Chun

family: Branigan

full_name: Patrick Branigan

given: Patrick

family: Blauvelt

full_name: Andrew Blauvelt

given: Andrew

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Germany
France
Czechia
Poland
Hungary
Australia
Spain
Canada

location_facility: St George Dermatology & Skin Cancer Centre

location_facility: Atlanta Dermatology, Vein & Research Center

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik

location_facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

location_facility: Suzanne Bruce and Associates - The Center for Skin Research

location_facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza

location_facility: Southern California Permanente Medical Group

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: University of Pittsburgh Department of Dermatology

location_facility: San Luis Dermatology & Laser Clinic, Inc

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Biological

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Brazil
Switzerland
Spain
Germany
France
Czechia
Greece
Israel
Poland
Romania
Australia
Belgium
New Zealand
Russian Federation
United States
United Kingdom
Canada

acronym: CheckMate 915

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Centre Hospitalier Universitaire Dijon Bocage

location_facility: Providence Cancer Center Oncology And Hematology Care

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: University Of Washington Cancer Care Alliance

location_facility: Hospital Universitario Y Politecnico La Fe

location_facility: Hospital Regional Universitario De Malaga

location_facility: The Beatson West Of Scotland Cancer Centre

location_facility: Washington University School Of Medicine

source: euctr

title: A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

summary: The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma


title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors

summary:
The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Incyte Corporation

location_country:
Italy
United Kingdom
Spain
Germany
Finland
France
Bulgaria
Lithuania
Poland
Belgium
Australia
New Zealand
China
United States
Latvia
Ukraine

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Katedra I Klinika Onkologii Um W Poznaniu Oddzial Ginekologii Onkologicznej

location_facility: University Hospital Krakow, Department of Oncology

location_facility: Medical University of Warsaw - 2Nd Department Obstetric and Gynecology

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: SZPITALE WOJEWï¿½DZKIE W GDYNI SPï¿½LKA Z OGRANICZONA ODPOWIEDZIALNOSCIA

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Regional Clinical Oncology Center Facility of State Higher Educational Institution

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Rmi Sumy Regional Clinical Oncology Dispensary

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: Podillia Regional Center of Oncology - Chemotherapy Department

location_facility: University of Texas Md Anderson Cancer Center

location_facility: Uzhgorod National University Clinical Base Uzhgorod Central City Clinical Hospital

location_facility: Stadtische Klinikum Munchen ? Neuperlach Klinik Fur Hamatologie Und Onkologie

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: The First Affiliated Hospital of Xian Jiaotong University

location_facility: Ko-Med Centra Kliniczne Osrodek Badan Klinicznych W Lublinie

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

status_simplified: Ongoing


status: Terminated

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:
Peru
Guatemala
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
India
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Turkey
Colombia
Saudi Arabia
Switzerland
Netherlands
Philippines
Bulgaria
Singapore
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Austria
Brazil
Serbia
Lebanon
Mexico
Czechia
Israel
Spain
Estonia
Latvia

acronym: SPIRIT

ipd_sharing: Yes

title: A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.

summary:
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.

The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:

Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and
New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.

By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

status_simplified: Unknown


title: Phase 2b, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

summary: This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.

lead_sponsor: Visterra, Inc.

location_country:
South Africa
Serbia
Spain
France
Bulgaria
Malaysia
Thailand
Georgia
Singapore
Belgium
Australia
New Zealand
Belarus
Estonia
Russian Federation
United States
Latvia
Canada
Turkey
Ukraine


title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma

summary:
This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC).

Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib.

Subjects will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent).

All subjects will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability.

Pharmacokinetic (PK) analysis are also included in study.

ReferenceCitation: Szarek M, Needle MN, Rini BI, Pal SK, McDermott DF, Atkins MB, Hutson TE, Escudier BJ. Q-TWiST Analysis of Tivozanib Versus Sorafenib in Patients With Advanced Renal Cell Carcinoma in the TIVO-3 Study. Clin Genitourin Cancer. 2021 Oct;19(5):468.e1-468.e5. doi: 10.1016/j.clgc.2021.03.018. Epub 2021 Apr 3.

family: Szarek

full_name: Michael Szarek

given: Michael

family: Needle

full_name: Michael N. Needle

given: Michael N.

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Pal

full_name: Sumanta K. Pal

given: Sumanta K.

family: McDermott

full_name: David F. McDermott

given: David F.

family: Atkins

full_name: Michael B. Atkins

given: Michael B.

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

family: Escudier

full_name: Bernard J. Escudier

given: Bernard J.

journal_name: Clinical Genitourinary Cancer

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

ReferenceCitation: Rini BI, Pal SK, Escudier BJ, Atkins MB, Hutson TE, Porta C, Verzoni E, Needle MN, McDermott DF. Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study. Lancet Oncol. 2020 Jan;21(1):95-104. doi: 10.1016/S1470-2045(19)30735-1. Epub 2019 Dec 3.

full_name: Brian I Rini

given: Brian I

full_name: Sumanta K Pal

given: Sumanta K

full_name: Bernard J Escudier

given: Bernard J

full_name: Michael B Atkins

given: Michael B

full_name: Thomas E Hutson

given: Thomas E

family: Porta

full_name: Camillo Porta

given: Camillo

family: Verzoni

full_name: Elena Verzoni

given: Elena

full_name: Michael N Needle

given: Michael N

full_name: David F McDermott

given: David F

journal_name: The Lancet Oncology

location_country:
Italy
United States
Germany
France
Czechia
Poland
Hungary
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

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

location_facility: Texas Oncology-El Paso Cancer Treatment Center

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Szpital Specjalist w Brzozowie Podkarpacki Ośrodek Onkologiczny

location_facility: St James's University Hospital / Leeds Teaching Hospitals

location_facility: Wake Forest University Baptist Medical Center (WFUBMC)

location_facility: AO Spedali Civili di Brescia, PO Spedali Civili

location_facility: Texas Oncology SW Fort Worth Cancer Center

location_facility: Institut de Cancérologie de l'Ouest Site Paul Papin

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: Texas Oncology - South Austin Cancer Center

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Uniklinik Köln Klinik und Poliklinik für Urologie

location_facility: CHRU de Tours - Hopital Bretonneau TOURS

location_facility: Nebraska Cancer Specialists (NCS) - Midwest Cancer Center

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

location_facility: ASST-Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: University Of UA Cancer Center(UACC)/DH-SJHMC

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Comprehensive Cancer Centers of Nevada (CCCN)

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Arizona Oncology - Phoenix - Deer Valley Women's Center Loca

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: MAGODENT Sp. z o.o. Szpital Onkologiczno-Kardiologiczny

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST

location_facility: Southampton University Hospitals Nhs Trust

location_facility: SZB Study Center University Hospital Bonn

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Investigative Clinical Research of Indiana

location_facility: IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

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

location_facility: Hackensack University Medical Center - John Theurer Cancer

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Texas Oncology - El Paso Cancer Treatment Center

location_facility: City of Hope Comprehensive Breast Cancer Center

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol

location_facility: COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii


ReferenceCitation: Mueller V, Wardley A, Paplomata E, Hamilton E, Zelnak A, Fehrenbacher L, Jakobsen E, Curtit E, Boyle F, Harder Brix E, Brenner A, Crouzet L, Ferrario C, Muñoz-Mateu M, Arkenau HT, Iqbal N, Aithal S, Block M, Cold S, Cancel M, Hahn O, Poosarla T, Stringer-Reasor E, Colleoni M, Cameron D, Curigliano G, Siadak M, DeBusk K, Ramos J, Feng W, Gelmon K. Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial). Eur J Cancer. 2021 Aug;153:223-233. doi: 10.1016/j.ejca.2021.05.025. Epub 2021 Jun 29.

family: Mueller

full_name: Volkmar Mueller

given: Volkmar

family: Wardley

full_name: Andrew Wardley

given: Andrew

family: Paplomata

full_name: Elisavet Paplomata

given: Elisavet

family: Hamilton

full_name: Erika Hamilton

given: Erika

family: Zelnak

full_name: Amelia Zelnak

given: Amelia

family: Fehrenbacher

full_name: Louis Fehrenbacher

given: Louis

family: Jakobsen

full_name: Erik Jakobsen

given: Erik

family: Curtit

full_name: Elsa Curtit

given: Elsa

family: Boyle

full_name: Frances Boyle

given: Frances

family: Harder Brix

full_name: Eva Harder Brix

given: Eva

family: Brenner

full_name: Andrew Brenner

family: Crouzet

full_name: Laurence Crouzet

given: Laurence

family: Ferrario

full_name: Cristiano Ferrario

given: Cristiano

family: Muñoz-Mateu

full_name: Montserrat Muñoz-Mateu

given: Montserrat

family: Arkenau

full_name: Hendrik-Tobias Arkenau

given: Hendrik-Tobias

family: Iqbal

full_name: Nayyer Iqbal

given: Nayyer

family: Aithal

full_name: Sramila Aithal

given: Sramila

family: Block

full_name: Margaret Block

given: Margaret

family: Cold

full_name: Soeren Cold

given: Soeren

family: Cancel

full_name: Mathilde Cancel

given: Mathilde

family: Hahn

full_name: Olwen Hahn

given: Olwen

family: Poosarla

full_name: Teja Poosarla

given: Teja

family: Stringer-Reasor

full_name: Erica Stringer-Reasor

given: Erica

family: Colleoni

full_name: Marco Colleoni

given: Marco

family: Cameron

full_name: David Cameron

given: David

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Edinburgh - Edinburgh Research Explorer

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repositories_institution: University College London - UCL Discovery

title: Preservation of quality of life in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial)

ReferenceCitation: Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020 Aug 10;38(23):2610-2619. doi: 10.1200/JCO.20.00775. Epub 2020 May 29.

name: Dana-Farber Cancer Institute, Boston, MA

name: University of Colorado Cancer Center, Aurora, CO

name: Carbone Cancer Center/University of Wisconsin, Madison, WI

name: Sarah Cannon Research Institute/Tennessee Oncology–Nashville, Nashville, TN

name: University of California Los Angeles Medical Center/Jonsson Comprehensive Cancer Center, Los Angeles, CA

name: Royal Marsden National Health Service (NHS) Foundation Trust, London, United Kingdom

name: Vanderbilt University Medical Center, Nashville, TN

name: University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada

name: Hospital Universitario Vall D’Hebron, Barcelona, Spain

name: Universitaetsklinikum Hamburg-Eppendorf, Hamburg, Germany

name: Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT

name: University of California at San Francisco, San Francisco, CA

name: Christie NHS Foundation Trust, Manchester Academic Health Science Centre & Division of Cancer Sciences, School of Medical Sciences, University of Manchester, Manchester, United Kingdom

name: Providence Cancer Institute, Portland, OR

name: Edinburgh Cancer Research Centre, Edinburgh, United Kingdom

name: University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC

name: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, University of Milano, Milan, Italy

name: British Columbia Cancer–Vancouver Centre, Vancouver, BC, Canada

name: German Breast Group, Neu-Isenburg, Germany

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Müller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):597-609. doi: 10.1056/NEJMoa1914609. Epub 2019 Dec 11. Erratum in: N Engl J Med. 2020 Feb 6;382(6):586.

name: From M.D. Anderson Cancer Center, Houston (R.K.M., G.H.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S. Loi); the Royal Marsden NHS Foundation Trust, London (A.O.), and Edinburgh Cancer Research Centre, Edinburgh (D.C.) — both in the United Kingdom; Winship Cancer Institute, Atlanta (E.P.); Sarah Cannon Research Institute/Tennessee Oncology–Nashville (E.H.) and Vanderbilt University Medical Center (V.A.), Nashville; University of California, Los Angeles, Medical Center–Jonsson...

ReferenceCitation: Murthy R, Borges VF, Conlin A, Chaves J, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018 Jul;19(7):880-888. doi: 10.1016/S1470-2045(18)30256-0. Epub 2018 May 24.

location_country:
Italy
Austria
United States
Switzerland
Spain
Germany
France
Czechia
Israel
Australia
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: InVO- Institut fUr Versorgungsforschung in der onkologie GbR

location_facility: James Cancer Hospital / Ohio State University

location_facility: Centro Hospitalar do Porto - Hospital Santo Antonio

location_facility: Presido Ospedaliero- Senatore Antonio Perrino

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Florida Cancer Specialists - North Region

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Colorado Hospital / University of Colorado

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Texas Oncology - San Antonio Medical Center Northeast

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: University of South Alabama - Mitchell Cancer Institute

location_facility: Hospital Clinico Univ De Santiago De Compostela

location_facility: Hospital Cuf Descobertas R. Mario Botas Parque das Nacoes

location_facility: Texas Oncology - Deke Slayton Cancer Center

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Florida Cancer Specialists - South Region

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Cancer Treatment Centers of America - Phoenix

location_facility: Torrance Memorial Physician Network - TRIO

location_facility: New York University (NYU) Cancer Institute

location_facility: Colchester Hospital University NHS Foundation Trust

location_facility: HOPE- Onkologisches Zentrum Rotkreuzklinikum

location_facility: Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University

location_facility: Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval

location_facility: Central Coast Medical Oncology Corporation TRIO

location_facility: Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris

location_facility: University of Alberta / Cross Cancer Institute

location_facility: Cancer Treatment Centers of America / Eastern Regional Medical Center

location_facility: University of Pennsylvania / Perelman Center for Advanced Medicine

location_facility: Illinois Cancer Specialists / Advocate Lutheran General Hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Paris Regional Medical Center / US Oncology

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: UCLA Medical Center / David Geffen School of Medicine

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: Kaiser Permanente San Marcos Medical Offices

location_facility: Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center

location_facility: Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Florida Cancer Specialists - East West Palm Beach, FL (SCRI)

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: Institute of Oncology of Southern Switzerland

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) - Onkologisches Zentrum - Interdisziplinaere Klinik und Poliklinik fuer Stammzelltransplantation

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: Nottingham University Hospitals NHS Trust

location_facility: The Center for Cancer and Blood Disorders: Fortworth

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: University of California at San Francisco

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

title: Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

summary:
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer.

There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo.

The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.


title: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

summary: The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

lead_sponsor: Clovis Oncology, Inc.

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

location_facility: London Health Science Center - Victoria Hospital

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Hospital Clínic i Provincial de Barcelona-Oncology

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Hospital General Universitario de Guadalajara

location_facility: Santa Chiara Hospital, Dept Medical Oncology

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: The Tel Aviv Sourasky Medical Center (Ichilov Hospital)

location_facility: Juravinski Cancer Centre Hamilton Health Services

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Rambam Health Care Campus (RHCC), Rambam Medical Center

location_facility: Alegent Health Bergan Mercy Hospital , GU Research Network

location_facility: Hospital Universitario Central de Asturias

location_facility: IRCCS Istituto Nazionale dei Tumori (INT)

location_facility: Equipe de Recherche Clinique, Département d'Oncologie/Hématologie

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: University of Modena and Reggio Emilia Medical Oncology

location_facility: Marques de Valdecilla University Hospital (HUMV)

location_facility: Gemeinschaftspraxis fur Hamatologie & Onkologie

location_facility: Kaiser Permanente Medical Center (Vallejo)

location_facility: Consultants in Medical Oncology Hematology

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Weill Cornell Medical College/NewYork-Presbyterian Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Florida Health Cancer Center

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Adelaide & Meath Hospital, Incorporating the National Children's Hospital

location_facility: Premier Urology Associates dba/AdvanceMed Research

location_facility: Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)

location_facility: Barwon Health, University Hospital Geelong


title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

summary: The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masiá M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.

ReferenceCitation: Rizzardini G, Overton ET, Orkin C, Swindells S, Arasteh K, Górgolas Hernández-Mora M, Pokrovsky V, Girard PM, Oka S, Andrade-Villanueva JF, Richmond GJ, Baumgarten A, Masiá M, Latiff G, Griffith S, Harrington CM, Hudson KJ, St Clair M, Talarico CL, Patel P, Cutrell A, Van Eygen V, D'Amico R, Mrus JM, Wu S, Ford SL, Chow K, Roberts J, Wills A, Walters N, Vanveggel S, Van Solingen-Ristea R, Crauwels H, Smith KY, Spreen WR, Margolis DA. Long-Acting Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):498-506. doi: 10.1097/QAI.0000000000002466.

family: Rizzardini

full_name: Giuliano Rizzardini

given: Giuliano

family: Overton

full_name: Edgar T. Overton

given: Edgar T.

family: Orkin

full_name: Chloe Orkin

given: Chloe

family: Swindells

full_name: Susan Swindells

given: Susan

family: Arasteh

full_name: Keikawus Arasteh

given: Keikawus

family: Górgolas Hernández-Mora

full_name: Miguel Górgolas Hernández-Mora

given: Miguel

family: Pokrovsky

full_name: Vadim Pokrovsky

given: Vadim

family: Girard

full_name: Pierre-Marie Girard

given: Pierre-Marie

family: Oka

full_name: Shinichi Oka

given: Shinichi

family: Andrade-Villanueva

full_name: Jaime F. Andrade-Villanueva

given: Jaime F.

family: Richmond

full_name: Gary J. Richmond

given: Gary J.

family: Baumgarten

full_name: Axel Baumgarten

given: Axel

family: Masiá

full_name: Mar Masiá

given: Mar

family: Latiff

full_name: Gulam Latiff

given: Gulam

family: Griffith

full_name: Sandy Griffith

given: Sandy

family: Harrington

full_name: Conn M. Harrington

given: Conn M.

family: Hudson

full_name: Krischan J. Hudson

given: Krischan J.

family: St. Clair

full_name: Marty St. Clair

given: Marty

family: Talarico

full_name: Christine L. Talarico

given: Christine L.

family: Patel

full_name: Parul Patel

given: Parul

family: Cutrell

full_name: Amy Cutrell

given: Amy

family: Van Eygen

full_name: Veerle Van Eygen

given: Veerle

family: D'Amico

full_name: Ronald D'Amico

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

repository_institution: Queen Mary University of London - Queen Mary Research Online

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

publisher: Ovid Technologies (Wolters Kluwer Health)

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

location_country:
Italy
United States
South Africa
Sweden
Mexico
Germany
France
Argentina
Australia
Russian Federation
Spain
Canada
Korea, Republic of


title: Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

summary: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

primary_purpose: Prevention

ReferenceCitation: Khorana AA, Barnard J, Wun T, Vijapurkar U, Damaraju CV, Moore KT, Wildgoose P, McCrae KR. Biomarker Signatures in Cancer Patients With and Without Venous Thromboembolism Events: A Substudy of CASSINI. Blood Adv. 2021 Nov 22. pii: bloodadvances.2021005710. doi: 10.1182/bloodadvances.2021005710. [Epub ahead of print]

name: Cleveland Clinic, Cleveland, Ohio, United States

family: Khorana

full_name: Alok A. Khorana

given: Alok A.

family: Barnard

full_name: John Barnard

given: John

name: University of California-Davis Cancer Center, Sacramento, California, United States

family: Wun

full_name: Ted Wun

given: Ted

name: Janssen Scientific Affairs, LLC, Titusville, New Jersey, United States

family: Vijapurkar

full_name: Ujjwala Vijapurkar

given: Ujjwala

family: Damaraju

full_name: CV Damaraju

given: CV

family: Moore

full_name: Kenneth Todd Moore

given: Kenneth Todd

family: Wildgoose

full_name: Peter Wildgoose

given: Peter

family: McCrae

full_name: Keith R McCrae

given: Keith R

journal_name: Blood Advances

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

name: Institute of Social and Preventive Medicine (ISPM); University of Bern; Bern Switzerland

family: Rutjes

full_name: Anne WS Rutjes

given: Anne WS

name: Department of Medical, Oral and Biotechnological Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Italy

family: Porreca

full_name: Ettore Porreca

given: Ettore

name: Internal Medicine Unit; "University G. D'Annunzio" Foundation; Chieti Italy

family: Candeloro

full_name: Matteo Candeloro

given: Matteo

family: Valeriani

full_name: Emanuele Valeriani

given: Emanuele

name: Department of Medicine and Ageing Sciences; University "G. D'Annunzio" of Chieti-Pescara; Chieti Scalo Italy

name: Department of Vascular Medicine; Academic Medical Center; Amsterdam Netherlands

family: Di Nisio

full_name: Marcello Di Nisio

given: Marcello

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

host_type: repository

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Vadhan-Raj S, McNamara MG, Venerito M, Riess H, O'Reilly EM, Overman MJ, Zhou X, Vijapurkar U, Kaul S, Wildgoose P, Khorana AA. Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study. Cancer Med. 2020 Sep;9(17):6196-6204. doi: 10.1002/cam4.3269. Epub 2020 Jul 14.

name: The UT MD Anderson Cancer Center Department of Sarcoma Medical Oncology Section of Cytokines and Supportive Oncology Houston TX USA

family: Vadhan‐Raj

full_name: Saroj Vadhan‐Raj

given: Saroj

name: Department of Medical Oncology The Christie NHS Foundation Trust & Division of Cancer Sciences University of Manchester Manchester United Kingdom

name: Klinik für Gastroenterologie Hepatologie und Infektiologie Universitätsklinikum Magdeburg Germany

name: Charité Universitätsmedizin Berlin Berlin Germany

name: Memorial Sloan Kettering Cancer Center Weill Cornell Medical College New York NY USA

name: The UT MD Anderson Cancer Center Houston TX USA

name: Janssen Research & Development, LLC Raritan NJ USA

name: Janssen Scientific Affairs, LLC Titusville NJ USA

name: Department of Hematology and Medical Oncology Cleveland Clinic Cleveland OH USA

title: Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre‐specified subgroup analysis of the randomized CASSINI study

ReferenceCitation: Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.

name: From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research–Texas Oncology, Tyler (H.A.Y...

ReferenceCitation: Khorana AA, Vadhan-Raj S, Kuderer NM, Wun T, Liebman H, Soff G, Belani C, O'Reilly EM, McBane R, Eikelboom J, Damaraju CV, Beyers K, Dietrich F, Kakkar AK, Riess H, Peixoto RD, Lyman GH. Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial. Thromb Haemost. 2017 Nov 1;117(11):2135-2145. doi: 10.1160/TH17-03-0171. Epub 2017 Sep 21.

name: The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

name: University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

name: University of Southern California Keck School of Medicine, Los Angeles, California, United States

name: Memorial Sloan Kettering Cancer Center, New York, New York, United States

name: Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States

name: Mayo Clinic, Rochester, Minnesota, United States

name: McMaster University, Hamilton, Ontario, Canada

name: Janssen Research and Development, Raritan, New Jersey, United States

name: University College London and Thrombosis Research Institute, London, United Kingdom

name: Charité University Hospitals, Berlin, Germany

name: Department of Medical Oncology, British Columbia Cancer Agency, Vancouver, British Columbia, Canada

name: Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, United States

location_country:
Brazil
United States
Germany
France
Bulgaria
Czechia
Belgium
Russian Federation
Canada
United Kingdom


title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

summary: The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.

ReferenceCitation: Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

family: Janjigian

full_name: Yelena Y Janjigian

given: Yelena Y

family: Shitara

full_name: Kohei Shitara

given: Kohei

family: Moehler

full_name: Markus Moehler

given: Markus

family: Garrido

full_name: Marcelo Garrido

given: Marcelo

family: Salman

full_name: Pamela Salman

given: Pamela

family: Shen

full_name: Lin Shen

given: Lin

family: Wyrwicz

full_name: Lucjan Wyrwicz

given: Lucjan

family: Yamaguchi

full_name: Kensei Yamaguchi

given: Kensei

family: Skoczylas

full_name: Tomasz Skoczylas

given: Tomasz

family: Campos Bragagnoli

full_name: Arinilda Campos Bragagnoli

given: Arinilda

family: Liu

full_name: Tianshu Liu

given: Tianshu

family: Schenker

full_name: Michael Schenker

given: Michael

family: Yanez

full_name: Patricio Yanez

given: Patricio

family: Tehfe

full_name: Mustapha Tehfe

given: Mustapha

family: Kowalyszyn

full_name: Ruben Kowalyszyn

given: Ruben

family: Karamouzis

full_name: Michalis V Karamouzis

given: Michalis V

family: Bruges

full_name: Ricardo Bruges

given: Ricardo

family: Zander

full_name: Thomas Zander

given: Thomas

family: Pazo-Cid

full_name: Roberto Pazo-Cid

given: Roberto

family: Hitre

full_name: Erika Hitre

given: Erika

family: Feeney

full_name: Kynan Feeney

given: Kynan

family: Cleary

full_name: James M Cleary

given: James M

family: Poulart

full_name: Valerie Poulart

given: Valerie

location_country:
Peru
Greece
Romania
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Singapore
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Hospital Clinico de la Universidad De Chile

location_facility: Hospital de Clinicas de Porto Alegre HCPA

location_facility: Interni hematologicka a onkologicka klinika

location_facility: California Pacific Medical Center Research Institute

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Azienda Ospedaliera Universitaria Di Modena

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Centrum Onkologiczne: Oddzial Onkologii Klinicznej oraz Poradnia Onkologiczna

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Instituto Nacional De Enfermedades Neoplasicas

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Hospital Municipal De Gastroenterologia Dr.Udaondo

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego

location_facility: Administradora Del Country S.A. - Clinica Del Country

location_facility: Baptist Health Medical Group Oncology LLC

location_facility: Texas Oncology, Texas Cancer Center At Medical City


title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

ReferenceCitation: Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.

name: Atlanta Center for Medical Research, Atlanta, GA, USA

family: Riesenberg

full_name: Robert Riesenberg

given: Robert

name: Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA

family: Werth

full_name: John Werth

given: John

family: Zhang

full_name: Yao Zhang

given: Yao

name: Current address: Cerevel Therapeutics, Boston, MA, USA

family: Duvvuri

full_name: Sridhar Duvvuri

given: Sridhar

family: Gray

full_name: David Gray

given: David

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Neurological Disorders

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via OAI-PMH doi match)

repository_institution: PubMed Central - Europe PMC

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: PF-06649751 efficacy and safety in early Parkinson’s disease: a randomized, placebo-controlled trial

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Israel
Germany
United States
France

location_facility: St Joseph's Hospital and Medical Center, Barrow Neurology Clinics

location_facility: AS Clinical Research Consultants of North Texas, PLLC

location_facility: University of Toledo, Gardner-McMaster Parkinson Center

location_facility: University of South Florida Carol and Frank Morsani Center for Advanced Health Care

location_facility: Praxis Oehlwein Outpatient clinic for PD, DBS, Movement Disorders

location_facility: University of South Florida Parkinson's Disease and Movement Disorders Center

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

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: University of South Florida Faculty Office Building


title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

summary: This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

ReferenceCitation: Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.

name: Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York

family: Mehran

full_name: Roxana Mehran

given: Roxana

name: Amsterdam University Medical Center, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands

family: Chandrasekhar

full_name: Jaya Chandrasekhar

given: Jaya

family: Urban

full_name: Philip Urban

given: Philip

name: Medical University of Vienna, Vienna, Austria

family: Lang

full_name: Irene M. Lang

given: Irene M.

name: Cardiovascular European Research Center, Massy, France

family: Windhoevel

full_name: Ute Windhoevel

given: Ute

name: European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Sudden Death Expert Center INSERM U 970, Paris Descartes University, Paris, France

family: Spaulding

full_name: Christian Spaulding

given: Christian

family: Copt

full_name: Samuel Copt

given: Samuel

family: Stoll

full_name: Hans-Peter Stoll

given: Hans-Peter

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

journal_name: JAMA Cardiology

oa_colors: green other

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ipd_sharing_description: The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint

lead_sponsor: Biosensors Europe SA

location_country:
Italy
Germany
France
Denmark
United States
United Kingdom
Canada

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Pinnacle Health Cardiovascular Institute

location_facility: Royal Bournemouth Hospital, Dorset Heart Centre

location_facility: Missouri Cardiovascular Specialists, LLP

location_facility: The University of Ottawa Heart Institute

location_facility: Novant Health Heart and Vascular Institute

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec

location_facility: Columbia University Medical Center/New York Presbyterian Hospital

location_facility: Penn State - Milton S. Hershey Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Weill Cornell Medical College-New York Presbyterian

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Centre Hospitalier de l'université de Montréal

location_facility: Service de Cardiologie Interventionnelle - Pôle Santé République

intervention_type: Device


ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

family: Richeldi

full_name: Luca Richeldi

given: Luca

family: Kolb

full_name: Martin Kolb

given: Martin

family: Jouneau

full_name: Stéphane Jouneau

given: Stéphane

family: Wuyts

full_name: Wim A. Wuyts

given: Wim A.

family: Schinzel

full_name: Birgit Schinzel

given: Birgit

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

family: Quaresma

full_name: Manuel Quaresma

given: Manuel

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

currency_apc_doaj: GBP

journal_name: BMC Pulmonary Medicine

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
publicatt.unicatt.it

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Behr J, Kolb M, Song JW, Luppi F, Schinzel B, Stowasser S, Quaresma M, Martinez FJ. Nintedanib and Sildenafil in Patients with Idiopathic Pulmonary Fibrosis and Right Heart Dysfunction. A Prespecified Subgroup Analysis of a Double-Blind Randomized Clinical Trial (INSTAGE). Am J Respir Crit Care Med. 2019 Dec 15;200(12):1505-1512. doi: 10.1164/rccm.201903-0488OC.

name: Department of Internal Medicine V, University of Munich, LMU, and Asklepios Chest Clinic Gauting, Memeber of the German Center for Lung Research, Germany

family: Behr

full_name: Jürgen Behr

given: Jürgen

name: McMaster University and St. Joseph’s Healthcare, Hamilton, Ontario, Canada

name: Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Song

full_name: Jin Woo Song

given: Jin Woo

name: University of Milan Bicocca, San Gerardo Hospital, Azienda Socio Sanitaria Territoriale Monza, Monza, Italy

family: Luppi

name: Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; and

name: Weill Cornell Medicine, New York, New York

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Kolb M, Raghu G, Wells AU, Behr J, Richeldi L, Schinzel B, Quaresma M, Stowasser S, Martinez FJ; INSTAGE Investigators. Nintedanib plus Sildenafil in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 Nov 1;379(18):1722-1731. doi: 10.1056/NEJMoa1811737. Epub 2018 Sep 15.

name: From McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München–Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim...

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

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: Nuevo Hospital Civil de Guadalajara DR. JUAN I. MENCHACA

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

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

location_facility: University of Florida College of Medicine

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Sanjivani Superspeciality Hospital Pvt. Ltd.

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Hospital General Universitario de Valencia

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Az. Ospedaliera Universitaria Polic.Tor Vergata

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliera Universitaria di Padova

title: INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment

summary: To assess efficacy and safety of concomitant treatment with nintedanib and sildenafil in Idiopathic Pulmonary Fibrosis (IPF) patients with advanced lung function impairment.


title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

acronym: STELLAR

summary: The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

lead_sponsor: Orbus Therapeutics, Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Canada
United Kingdom

location_facility: Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III

location_facility: Texas Oncology Austin Brain Tumor Center

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg

location_facility: Fondazione IRCCS - Instituto Neurologico Carlo Besta

location_facility: Boca Raton Regional Hospital, Eugene M. & Christine E. Lynn Cancer Institute

location_facility: The Cleveland Clinic, Richard E. Jacobs Health Center

location_facility: The University of Florida Health System - UF Health Neurosurgery

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Oncohematology IRST Cesena

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: University of North Carolina - Chapel Hill

location_facility: Hôpital Pierre Wertheimer - Hospices Civils de Lyon

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Universtaetsklinikum Erlangen - Neurologische Klinik

location_facility: Cliniques Universitaires UCL De Mont-Godinne

location_facility: University of California San Francisco Medical Center

location_facility: Universtatsklinikum Koln Klinik und Poliklinik fur Neurologie

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Louisiana State University Health Sciences Center New Orleans

location_facility: Universtaetsklinikum Heidelberg - Neurologische Klinik

location_facility: Columbia University Medical Center, The Neurological Institute

location_facility: Montreal Neurological Institute and Hospital

location_facility: Universtaetsklinikum Giessen und Marburg GmbH - Marburg - Neurologische Klinik

location_facility: Dana Farber Cancer Institute, Brigham and Women's Hospital

location_facility: Institut de Cancerologie de l'Ouest - Angers

location_facility: University of California Irvine Medical Center

location_facility: Ruhr-Universitaet Bochum - Knappschaftskrankenhaus Bochum-Langendreer - Neurologische

location_facility: Universitätsklinik Leipzig - Medizinische Klinik und Poliklinik I Klinik für Strahlentherapie

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Istituto Nazionale dei Tumori Regina Elena - IRE

location_facility: Edinburgh Cancer Centre - Western General Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: OhioHealth Research and Innovation Institute

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: Medical University of South Carolina, Hollings Cancer Center


ReferenceCitation: Atkins MB, Rini BI, Motzer RJ, Powles T, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Gurney H, Oudard S, Uemura M, Lam ET, Grüllich C, Quach C, Carroll S, Ding B, Zhu QC, Piault-Louis E, Schiff C, Escudier B. Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naïve Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2020 Jun 1;26(11):2506-2514. doi: 10.1158/1078-0432.CCR-19-2838. Epub 2020 Mar 3.

family: Atkins

full_name: Michael B. Atkins

given: Michael B.

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

family: Powles

full_name: Thomas Powles

given: Thomas

family: McDermott

full_name: David F. McDermott

given: David F.

family: Suarez

full_name: Cristina Suarez

given: Cristina

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

family: Stadler

full_name: Walter M Stadler

given: Walter M

family: Donskov

full_name: Frede Donskov

given: Frede

family: Gurney

full_name: Howard Gurney

given: Howard

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Uemura

full_name: Motohide Uemura

given: Motohide

family: Lam

full_name: Elaine T Lam

given: Elaine T

family: Grüllich

full_name: Carsten Grüllich

given: Carsten

family: Quach

full_name: Caroleen Quach

given: Caroleen

family: Carroll

full_name: Susheela Carroll

given: Susheela

family: Ding

full_name: Beiying Ding

given: Beiying

family: Zhu

full_name: Qian Zhu

given: Qian

family: Piault-Louis

full_name: Elisabeth Piault-Louis

given: Elisabeth

family: Schiff

full_name: Christina Schiff

given: Christina

family: Escudier

full_name: Bernard Escudier

given: Bernard

title: Patient-reported outcomes from the phase 3 randomized IMmotion151 trial: atezolizumab + bevacizumab vs sunitinib in treatment-naive metastatic renal cell carcinoma

ReferenceCitation: Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.

location_country:
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Singapore
United States
Germany
United Kingdom
Italy
Brazil
Bosnia and Herzegovina
Mexico
Czechia
Spain
Turkey

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

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Rocky Mountain Cancer Center; Medical Oncology

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology

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

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

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

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Florida Cancer Specialists - Port Charlotte

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

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Cleveland Clinic Foundation; Taussig Cancer Center

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: New York Oncology Hematology,P.C.-Albany

location_facility: Osaka International Cancer Institute; Urology

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Az. Osp. Cardarelli; Divisione Di Oncologia

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

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

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

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Centre Francois Baclesse; Urologie Gynecologie

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

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

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Niigata University Medical & Dental Hospital

location_facility: Oncology and Hematology Associates of SW Virginia-Raonoke

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Lynn Cancer Institute/Boca Raton Regional Hospital

location_facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

location_facility: Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

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

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: University of California at Irvine Medical Center; Department of Oncology

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

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

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Centre D'Oncologie de Gentilly; Oncology

title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.