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Brief Title: A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Official Title: A Phase II, Multicenter, Randomized, Double-Blind Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Study ID: NCT05852691
Brief Summary: The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Blood and Specialty Clinic, Los Alamitos, California, United States
Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, California, United States
UCSF Comprehensive Cancer Ctr, San Francisco, California, United States
Providence St Johns Health Center, Santa Monica, California, United States
Cedars Sinai Outpatient Cancer Center, West Hollywood, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
University of Colorado Health Lone Tree Medical Center, Lone Tree, Colorado, United States
Mercy Medical Center, Baltimore, Maryland, United States
Frederick Health Hospital, Frederick, Maryland, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Novant Health Presbyterain Medical Center, Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside, Portland, Oregon, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Swedish Cancer Inst., Seattle, Washington, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Cemic; Oncologia Clinica, Buenos Aires, , Argentina
Centro Oncologico Korben, Caba, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Sanatorio Parque de Rosario, Rosario, , Argentina
Hospital Provincial del Centenario, Rosario, , Argentina
ICON Cancer Care Adelaide, Kurralta Park, South Australia, Australia
Sunshine Hospital; Oncology Research, St Albans, Victoria, Australia
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit, Bull Creek, Western Australia, Australia
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital do Cancer de Pernambuco - HCP, Recife, PE, Brazil
Hospital de Amor Amazônia, Porto Velho, RO, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, Sao Paulo, SP, Brazil
Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie, Novy Jicin, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN, Praha 4 - Krc, , Czechia
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol, Praha 5, , Czechia
Aalborg Universitetshospital; Onkologisk Afdeling, Aalborg, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R, Odense C, , Denmark
Vejle Sygehus; Onkologisk Afdeling, Vejle, , Denmark
Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe, Esslingen, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg, , Germany
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie, Hannover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR, Koblenz, , Germany
Dres. Andreas Köhler und Roswitha Fuchs, Langen, , Germany
Onkologische Schwerpunktpraxis Lübeck, Lübeck, , Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde, Mainz, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie, Münster, , Germany
HELIOS Klinikum Schwerin; Frauenklinik, Schwerin, , Germany
Somogy Varmegyei Kaposi Mor Oktato Korhaz; Onkologiai Osztaly, Kaposvár, , Hungary
Hadassah University Hospital - Ein Kerem; Oncology, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Sourasky / Ichilov Hospital; Dept. of Oncology, Tel Aviv, , Israel
Ospedale Civile; Unita Operativa Di Oncologia Medica, Livorno, Toscana, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
OncoMed; Supportive Care, Ciudad de México, Mexico CITY (federal District), Mexico
Centro de Investigacion Clinica de Oaxaca, Oaxaca de Juárez, Oaxaca, Mexico
Centro Medico Monte Carmelo, Arequipa, , Peru
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Instituto Peruano de Oncología y Radioterapia, Lima, , Peru
Oncosalud Sac; Oncología, Lima, , Peru
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii, Bydgoszcz, , Poland
Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi, Gliwice, , Poland
?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii, Kielce, , Poland
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Kraków, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warszawa, , Poland
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Cancercare, Port Elizabeth, , South Africa
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Hospital Quiron de Madrid; Servicio de Oncologia, Pozuelo de Alarcon, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia, El Palmar, Murcia, Spain
Complejo Hospitalario de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei City, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Chang Gung Memorial Hosipital at Linkou, Taoyuan City, , Taiwan
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR