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Brief Title: Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Official Title: Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Study ID: NCT04589845
Brief Summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southern Cancer Center, Daphne, Alabama, United States
Western Regional Medical Center at Cancer Treatment Centers of America, Goodyear, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
Kaiser Permanente Los Angeles; Clinic/Infusion -LA, Los Angeles, California, United States
USC Norris Cancer Center, Los Angeles, California, United States
Hoag Memorial Hospital, Newport Beach, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
University of California at San Francisco, San Francisco, California, United States
Sarcoma Oncology Center, Santa Monica, California, United States
Children's Hospital Colorado; Center For Cancer/Blood Disorder, Aurora, Colorado, United States
Christiana Care Health Srvcs; Helen F Graham Can Center, Newark, Delaware, United States
University of Florida, Gainesville, Florida, United States
Miami Cancer Institute of Baptist Health, Inc., Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
University Cancer & Blood Center, LLC; Research, Athens, Georgia, United States
St. Alphonsus, Boise, Idaho, United States
Midwestern Regional Med Center, Zion, Illinois, United States
Horizon Oncology Research, Inc., Lafayette, Indiana, United States
New England Cancer Specialists, Scarborough, Maine, United States
Maryland Hematology & Oncology. P.A., Silver Spring, Maryland, United States
St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Metro-Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana, Billings, Montana, United States
Nebraska Methodist Hospital; Cancer Center, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of New Mexico; Comprehensive Cancer Center, Albuquerque, New Mexico, United States
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
Eastchester Center for Cancer Care, Bronx, New York, United States
New York Cancer and Blood Specialists - Setauket Medical Oncology, East Setauket, New York, United States
National Translational Research Group, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Barrett Cancer Center, Cincinnati, Ohio, United States
Oncology Hematology Care Inc, Cincinnati, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Consultants in Medical Oncology and Hematology, Broomall, Pennsylvania, United States
Alliance Cancer Specialists, Horsham, Pennsylvania, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America; Eastern Regional Medical Center, Philadelphia, Pennsylvania, United States
PRISMA Health - Greenville, Greenville, South Carolina, United States
The West Clinic; West Cancer Center, Germantown, Tennessee, United States
St. Jude Children'S Research Hospital, Memphis, Tennessee, United States
Texas Onc-Central Austin CA Ct, Austin, Texas, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Cook Childrens Medical Center, Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology- Northeast Texas, Tyler, Texas, United States
Virginia Cancer Specialists - Leesburg, Leesburg, Virginia, United States
Northwest Medical Specialties, PLLC; Research Department, Tacoma, Washington, United States
Froedtert and The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Kinghorn Cancer Centre; St Vincents Hospital, Darlinghurst, New South Wales, Australia
Sydney Children's Hospital, Randwick, New South Wales, Australia
Royal Darwin Hospital; Alan Walker Cancer Centre, Tiwi, Northern Territory, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre; Medical Oncology, Melbourne, Victoria, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Hospital Moinhos de Vento, Porto Alegre, RS, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Hospital A. C. Camargo; Oncologia, Sao Paulo, SP, Brazil
Clínica Onco Star - Rede D'Or, Sao Paulo, SP, Brazil
BC Cancer ? Vancouver, Vancouver, British Columbia, Canada
London Health Sciences Centre · Victoria Hospital; Department of Medicine, London, Ontario, Canada
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
The Hospital for Sick Children, Toronto, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
Jilin Cancer Hospital, Changchun, , China
West China Hospital - Sichuan University, Chengdu City, , China
Zhongshan Hospital Fudan Unvierstiy, Shanghai City, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Shanghai East Hospital, Shanghai, , China
Tianjin Cancer Hospital, Tianjin, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Aarhus Universitetshospital; Kræftafdelingen, Aarhus N, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Oscar Lambret; Service de Pediatrie, Lille, , France
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie, Lyon, , France
Hopital de la Timone, Marseille, , France
Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, , France
Institut de Cancerologie Gustave-Roussy (IGR), Villejuif, , France
Uniklinik Essen, Essen, , Germany
Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I, Freiburg, , Germany
Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie, Göttingen, , Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II, Hamburg, , Germany
Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie, Hannover, , Germany
SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm., Heilbronn, , Germany
Praxis für Hämatologie, Onkologie und Palliativmedizin, Mönchengladbach, , Germany
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III, München, , Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III, Ulm, , Germany
Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU, Würzburg, , Germany
Hong Kong Children's Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital; Department of Clinical Onocology, Shatin, , Hong Kong
Rambam Health Care Campus; Oncology, Haifa, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Sourasky / Ichilov Hospital; Dept. of Oncology, Tel Aviv, , Israel
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica, Roma, Lazio, Italy
Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1, Roma, Lazio, Italy
Asst Degli Spedali Civili Di Brescia, Brescia, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica, Milano, Lombardia, Italy
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita, Torino, Piemonte, Italy
Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica, Firenze, Toscana, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica, Siena, Toscana, Italy
National Cancer Center Hospital East, Chiba, , Japan
Kindai University Hospital, Osaka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital- Adult Site, Seoul, , Korea, Republic of
Seoul National University Hospital- Pediatric Site, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center- Adult Site, Seoul, , Korea, Republic of
Samsung Medical Center- Pediatric Site, Seoul, , Korea, Republic of
Prinses Maxima Centrum, Utrecht, , Netherlands
Auckland City Hospital, Cancer and Blood Research, Auckland, , New Zealand
Christchurch Hospital; Dept of Oncology, Christchurch, , New Zealand
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk, , Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers, Warszawa, , Poland
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center, San Juan, , Puerto Rico
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Hospital Sant Joan De Deu, Esplugues De Llobregas, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus, Madrid, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Universitätsspital Basel (USB), Basel, , Switzerland
Ospedale Regionale di Bellinzona Medizin Onkologie, Bellinzona, , Switzerland
Inselspital, Klinik und Poliklinik für Medizinische Onkologie, Bern, , Switzerland
Unversitätsspital Zürich, Zürich, , Switzerland
Taichung Veterans General Hospital; Division of Hema-Oncology, Taichung, , Taiwan
National Cheng Kung University Hospital; Oncology, Tainan, , Taiwan
Taipei Veterans General Hospital; Department of Oncology, Taipei City, , Taiwan
Chang Gung Memorial Hospital-Linkou; Dept of Oncology, Taoyuan County, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
University College London Hospital, London, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital, London, , United Kingdom
Royal Manchester Children?s Hospital, Manchester, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR