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Brief Title: A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors
Official Title: An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Study ID: NCT02650713
Brief Summary: This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, flat dose of 1200 mg given Q3W (every 3 weeks) of atezolizumab, to evaluate the safety and determine the MTD of RO6958688 in combination with atezolizumab. Part IB is a dose/schedule finding part that will explore different administration schedules of RO6958688 in combination with atezolizumab (1200 mg Q3W) to establish the appropriate dose/schedule of RO6958688 in combination with atezolizumab.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA Cancer Center, Santa Monica, California, United States
Stanford Comprehensive Cancer Center, Stanford, California, United States
University Of Colorado, Aurora, Colorado, United States
Smilow Cancer Hospital at Yale- New Haven Oncology Investigational Drug Pharmacy, New Haven, Connecticut, United States
Dana Farber Can Ins, Boston, Massachusetts, United States
Columbia Univ Med Ctr, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sarah Cannon Cancer Center, Germantown, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut Gustave Roussy, Villejuif, , France
IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative, Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica, Siena, Toscana, Italy
Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie, Amsterdam, , Netherlands
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
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR