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Brief Title: A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors
Official Title: Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors
Study ID: NCT02323191
Brief Summary: This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment. Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.
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
Massachusetts General Hospital., Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber - Harvard, Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center Breast & Imaging Center, New York, New York, United States
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse, , France
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, , France
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Centro Integral Oncológico Clara Campal Ensayos Clínicos START, Madrid, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR