Spots Global Cancer Trial Database for Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
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Trial Identification
Brief Title: Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma
Official Title: A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Study ID: NCT05359861
Conditions
Study Description
Brief Summary: This is a Phase 2 trial composed of an open label Lead-In followed by a Randomized Phase designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo (inactive substance) in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC.
Detailed Description: This is a Phase 2 trial designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab (Arm A) compared to placebo in combination with atezolizumab plus bevacizumab (Arm B) in patients with first-line advanced or metastatic HCC. After a Lead-In Phase of up to 30 patients who will receive open-label SRF388 + atezolizumab + bevacizumab, the blinded Randomized Phase will randomize approximately 104 patients with a 1:1 allocation to Arm A or Arm B and stratified by geographic region (Asia excluding Japan vs. rest of world) and Barcelona Clinic Liver Cancer (BCLC) stage (B or C).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Louisville VA Medical Center - Robley Rex VA Medical Center, Louisville, Kentucky, United States
Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, United States
University of Michigan Health System (UMHS), Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center, New York, New York, United States
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI)), New York, New York, United States
University of Oklahoma Health Sciences Center - Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Sarah Cannon Research Institute - Tennessee Oncology, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute - Tennessee Oncology, Nashville, Tennessee, United States
The Alfred Hospital, Melbourne, , Australia
Royal Melbourne Hospital, Melbourne, , Australia
Seoul National University Bundang Hospital, Seongnamsi Bundang, Gyeonggi-Do, Korea, Republic of
The Catholic University of Korea - St. Vincent's Hospital, Suwon-si, Gyeonggi-Do, Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Daegu Catholic University Medical Center (DCUMC), Daegu, , Korea, Republic of
Ajou University Hospital, Gyeonggi-do, , Korea, Republic of
CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center), Gyeonggi-do, , Korea, Republic of
Chonnam National University (CNU) - Chonnam National University Hwasun Hospital (CNUHH), Jeollanam-do, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Gangnam Severance Hospital - Cancer Hospital, Seoul, , Korea, Republic of
Korea University Medical Center - Korea University Anam Hospital, Seoul, , Korea, Republic of
University of Ulsan College of Medicine - Asan Medical Center (AMC), Seoul, , Korea, Republic of
Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center, Seoul, , Korea, Republic of
Buddhist Tzu Chi General Hospital - Hualien Tzu Chi Medical Center, Hualien City, , Taiwan
E-Da Cancer Hospital, Kao-Hsiung, , Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Contact Details
Name: Vienna Reichert, PhD
Affiliation: Coherus Biosciences, Inc.
Role: STUDY_CHAIR
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