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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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