Spots Global Cancer Trial Database for Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
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Trial Identification
Brief Title: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
Official Title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Study ID: NCT03485209
Study Description
Brief Summary: This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). * In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. * In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin * In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab. * In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.
Detailed Description: The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin or tisotumab vedotin in combination with other anticancer agents. Patients who meet eligibility criteria will be enrolled into cohorts based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous non-small cell lung cancer (sqNSCLC), exocrine pancreatic adenocarcinoma, and head and neck squamous cell carcinoma (HNSCC).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego / Moores Cancer Center, La Jolla, California, United States
University of California Davis, Sacramento, California, United States
Stanford Cancer Center / Blood and Marrow Transplant Program, San Jose, California, United States
Poudre Valley Health System (PVHS), Fort Collins, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Shands Cancer Center / University of Florida, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University Cancer & Blood Center, LLC, Athens, Georgia, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee / Kishwaukee Cancer Center, DeKalb, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Ingalls Cancer Care / Ingalls Memorial Hospital, Harvey, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Community Health Network, Indianapolis, Indiana, United States
University of Kansas Cancer Center, Fairway, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
HealthPartners Institute, Saint Louis Park, Minnesota, United States
Washington University in St Louis, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medicine, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center / Wake Forest University, Winston-Salem, North Carolina, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pennsylvania / Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Texas Oncology - Fort Worth, Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Renovatio Clinical, The Woodlands, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
University of Alberta / Cross Cancer Institute, Edmonton, Alberta, Canada
Hospitalier Jean Minjoz, Besancon, Other, France
Centre léon Bérard, LYON cedex 08, Other, France
APHM Hôpital Nord, Marseille Cedex 20, Other, France
Hopital Prive du Confluent, Nantes Cedex 2, Other, France
Hopital Foch, Suresnes, Other, France
Institut Gustave Roussy, Villejuif Cedex, Other, France
Ruhr-Uni. Bochum, St. Josef-Hospital, Bochum, Other, Germany
Universitätsklinikum Halle-Universitätsklinik und Poliklinik, Halle, Other, Germany
Vincentius-Diakonissen-Kliniken gAG, Karlsruhe, Other, Germany
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Other, Italy
Azienda Ospedaliero Universitaria (AOU) Master Domin U.O. Oncologia Medica Traslazzionale, Catanzaro, Other, Italy
Istituto Europeo di Oncologia, Milano, Other, Italy
Seconda Università degli Studi di Napoli, AOU, Napoli, Other, Italy
Azienda USL Toscana Centro, Pistoia, Other, Italy
Oncologia Medica, Ospedale Civile S. Maria delle Croci, Ravenna, Other, Italy
PU Campus Bio-medico di Roma, Roma, Other, Italy
Pan American Center for Oncology Trials, LLC, Rio Piedras, , Puerto Rico
Hospital Universitari Germans Trias i Pujol, Badalona, Other, Spain
Hospital Quironsalud Barcelona Instituto Oncologico Baselga, Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
Hospital Universitario Ramon y Cajal Servicio de Oncologia Medica Oficina de Ensayos Clinicos, Madrid, Other, Spain
HM Centro Integral Oncologico Clara Campal, Madrid, Other, Spain
Althaia Xarxa Assistencial Manresa, Manresa, Other, Spain
Son LLatzer University Hospital, Palma de Mallorca, Other, Spain
Guys and St Thomas Hospital, London, Other, United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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