title: Phase 3 Randomized Study Comparing X-396 (Ensartinib) to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

ReferenceCitation: Horn L, Wang Z, Wu G, Poddubskaya E, Mok T, Reck M, Wakelee H, Chiappori AA, Lee DH, Breder V, Orlov S, Cicin I, Cheng Y, Liu Y, Fan Y, Whisenant JG, Zhou Y, Oertel V, Harrow K, Liang C, Mao L, Selvaggi G, Wu YL. Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):1617-1625. doi: 10.1001/jamaoncol.2021.3523.

lead_sponsor: Xcovery Holding Company, LLC

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Turkey
Brazil
Canada
China
Germany
Korea, Republic of
France
Netherlands

location_facility: The University of Hong Kong/Queen Mary Hospital

location_facility: Washington University School of Medicine

location_facility: Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin

location_facility: North Shore Hematology-Oncology Associates, PC

location_facility: Tianjin Medical University General Hospital Mailing No.154 Anshan Avenue Heping District

location_facility: Klinik m. S. Infektiologie & Pneumologie

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

location_facility: Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria

location_facility: Centro Operativo Studi Clinici S.C.Oncologia Medica

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

location_facility: State Budgetary Institution of Healthcare of the city of Moscow "MOSCOW CITY ONCOLOGY HOSPITAL # 62"

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Maastricht University Medical Centre (MUMC)

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: ICO Girona - Hospital Doctor Josep Trueta

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Trakya University Balkan Oncology Hospital

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: University of Wisconsin Clinical Science Center

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Fundacao do ABC Faculdade de Medicina do ABC

location_facility: Klinik Löwenstein gGmbH Med. Klinik II Onkologie

location_facility: Beijing Chest Hospital,Capital Medical University

location_facility: Rabin Medical Center Institute of Oncology, Davidoff Center

location_facility: The First Hospital of China Medical University

location_facility: Kaiser Permanente Hawaii- Moanalua Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Instituto do Câncer do Estado de São Paulo

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

location_facility: The First Bethune Hospital of Jilin University

location_facility: Praxis Hämatologie und Onkologie Stolberg

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Krajská zdravotní, a.s., Masarykova nemocnice

location_facility: Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Centro Riferimento Oncologico CRO Aviano

location_facility: Rambam Health Care Campus/ Oncology Institute


title: Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

summary: The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lebbé C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
United States
France
Israel
Germany

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych

location_facility: Washington University School Of Medicine

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote

location_facility: University Medical Center Groningen (Umcg)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

summary: The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

ReferenceCitation: Chu Y, Lee S, Shah T, Yin C, Barth M, Miles RR, Ayello J, Morris E, Harrison L, Van de Ven C, Galardy P, Goldman SC, Lim MS, Hermiston M, McAllister-Lucas LM, Giulino-Roth L, Perkins SL, Cairo MS. Ibrutinib significantly inhibited Bruton's tyrosine kinase (BTK) phosphorylation,in-vitro proliferation and enhanced overall survival in a preclinical Burkitt lymphoma (BL) model. Oncoimmunology. 2018 Oct 11;8(1):e1512455. doi: 10.1080/2162402X.2018.1512455. eCollection 2019.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Romania
Spain
United Kingdom
Russian Federation
Netherlands
Canada
Ukraine
Sweden
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Germany
Bulgaria
Czechia

intervention_type: Drug