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Brief Title: A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors
Official Title: A Phase 1b, Open-Label, Multi-Center, Dose Escalation Study of the Safety, Pharmacokinetics, and Therapeutic Activity of Cergutuzumab Amunaleukin, an Immunocytokine, Which Consists of a Variant of Interleukin 2 (IL 2v), That Targets Carcinoembryonic Antigen (CEA), and Atezolizumab, an Antibody That Targets Programmed Death-Ligand 1 (PD-L1), Administered Intravenously, in Patients With Locally Advanced and/or Metastatic Solid Tumors
Study ID: NCT02350673
Brief Summary: This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.
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
Columbia Univ Med Ctr, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
SCRI-Tennessee Oncology, Nashville, Tennessee, United States
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
Herlev Hospital; Onkologisk afdeling, Herlev, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Clinica Universitaria de Navarra; Servicio de oncología, Pamplona, Navarra, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
CHUV; Departement d'Oncologie, Lausanne, , Switzerland
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR