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Brief Title: A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Official Title: A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma
Study ID: NCT05805501
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham; Comprehensive Cancer Center, Birmingham, Alabama, United States
UC Irvine Medical Center, Orange, California, United States
University of Colorado, Aurora, Colorado, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Florida Cancer Specialists - Fort Myers (Broadway), Fort Myers, Florida, United States
EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center, Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building, Baltimore, Maryland, United States
Greco-Hainesworth Centers for Research; ETN (East Tennessee), Chattanooga, Tennessee, United States
Thompson Cancer Survival Center, Knoxville, Tennessee, United States
Tennessee Oncology - Nashville, Nashville, Tennessee, United States
Vanderbilt University Medical Center; Vanderbilt University, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Sunshine Coast University Hospital; The Adem Crosby Centre, Birtinya, Queensland, Australia
ICON Cancer Care Adelaide, Kurralta Park, South Australia, Australia
Peking University First Hospital, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing City, , China
Tianjin Cancer Hospital, Tianjin, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Institut Sainte Catherine;Recherche Clinique, Avignon, , France
CHU Besançon - Hôpital Jean Minjoz, Besançon Cedex, , France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre, Bordeaux, , France
Centre Francois Baclesse; Oncologie, Caen, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut Gustave Roussy; Oncologie Medicale, Villejuif, , France
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie, Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II, Hamburg, , Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie, Hannover, , Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik, München, , Germany
Studienpraxis Urologie, Nürtingen, , Germany
Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen, , Germany
Universitätsklinikum Ulm; Klinik für Urologie, Ulm, , Germany
National Cancer Center, Goyang-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny, Brzozów, , Poland
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii, Bydgoszcz, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Kraków, , Poland
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii, Lublin, , Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii, Pozna?, , Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o., Warszawa, , Poland
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Ramon y Cajal;Oncology Dept., Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe; Oncologia, Valencia, , Spain
East Lancashire Hospitals NHS Trust, Burnley, , United Kingdom
Colchester General Hospital, Colchester, Essex, , United Kingdom
Medway Maritime Hospital, Gillingham, , United Kingdom
Barts & London School of Med; Medical Oncology, London, , United Kingdom
Royal Marsden Hospital; Dept of Med-Onc, London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Nottingham City Hospital; Oncology, Nottingham, , United Kingdom
Plymouth Oncology Centre; Clinical Trials Unit, Plymouth, , United Kingdom
Royal Marsden Hospital; Institute of Cancer Research, Sutton, , United Kingdom
Singleton Hospital; Cancer Institute, Swansea, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-LaRoche
Role: STUDY_DIRECTOR