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Brief Title: Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)
Official Title: An Open-Label, Multi-Center, Randomized, Dose-Escalation, Phase 1b Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 in Combination With Atezolizumab ± Bevacizumab in Patients With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma
Study ID: NCT03063762
Brief Summary: This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale Cancer Center; Medical Oncology, New Haven, Connecticut, United States
Northwestern Center for Clinical Research; Cancer Center, Chicago, Illinois, United States
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Herlev Hospital; Afdeling for Kræftbehandling, Herlev, , Denmark
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Universitätsklinikum Tübingen; Klinik für Urologie, Tübingen, , Germany
Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU, Würzburg, , Germany
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia, Modena, Emilia-Romagna, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia, Pavia, Lombardia, Italy
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Barts & London School of Med; Medical Oncology, London, , United Kingdom
The Christie, Manchester, , United Kingdom
Southampton General Hospital; Medical Oncology, Southampton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR