Trial Title:
A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma
NCT ID:
NCT05908786
Condition:
Carcinoma, Hepatocellular
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab will be administered at a dose of 1200 mg by IV infusion on Day 1.
Arm group label:
Atezo + Bev
Arm group label:
Atezo + Bev +Tira
Other name:
Tecentriq
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1.
Arm group label:
Atezo + Bev
Arm group label:
Atezo + Bev +Tira
Arm group label:
Tobe + Bev
Other name:
Avastin
Intervention type:
Drug
Intervention name:
Tiragolumab
Description:
Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1.
Arm group label:
Atezo + Bev +Tira
Intervention type:
Drug
Intervention name:
Tobemstomig
Description:
Tobemstomig will be administered at a dose of 600 mg by IV infusion on Day 1
Arm group label:
Tobe + Bev
Other name:
RO7247669
Summary:
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate
neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is
designed with the flexibility to open new treatment arms as new agents become available,
close existing treatment arms that demonstrate minimal clinical activity or unacceptable
toxicity, or modify the participant population.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of HCC confirmed either histologically or clinically according to AASLD
criteria for patients with cirrhosis. For participants without cirrhosis,
histological confirmation is mandatory.
- HCC that is amenable to R0 surgical resection with curative intent in the opinion of
the surgeons and oncologists or hepatologists involved in the care of the
participant. Patients presenting with resectable HCC within or beyond Milan criteria
(without extrahepatic spread or macrovascular invasion) are eligible.
- Measurable disease (at least one target lesion) according to RECIST v1.1 as
determined by the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days
prior to randomization
- Child-Pugh Class A within 7 days prior to randomization
- Negative HIV test at screening
- No prior locoregional or systemic treatment for HCC
- Adequate hematologic and end-organ function
- Documented virology status of hepatitis
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or
use contraception, and agreement to refrain from donating sperm
General Exclusion Criteria:
- Presence of extrahepatic disease or macrovascular invasion
- Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other
rare variants of HCC
- History of hepatic encephalopathy if clinically significant within one year prior to
initiation of study treatment
- Moderate or severe ascites
- Active co-infection with HBV and HCV
- Known active co-infection with HBV and hepatitis D viral infection
- Prior treatment with CD137 agonists or immune checkpoint inhibitors, including
anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with investigational therapy within 28 days prior to initiation of study
treatment
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or
that are at high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months
prior to initiation of study treatment
- Inadequately controlled hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- Significant vascular disease within 6 months prior to initiation of study treatment
- History of hemoptysis within 1 month prior to initiation of study treatment
- Evidence of bleeding diathesis or significant coagulopathy
- Current or recent (<= 10 days prior to initiation of study treatment) use of
full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic
purposes
- History of abdominal or tracheoesophageal fistula, GI perforation or intra-abdominal
abscesses within 6 months prior to initiation of study treatment
- History of intestinal obstruction and/or clinical sign or symptoms of GI obstruction
- Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
- Grade >= proteinuria
- Major surgical procedure, open biopsy, or significant traumatic injury, or abdominal
surgery, interventions or traumatic injuries, or anticipation of need of major
surgical procedure other than potentially curative liver resection
- Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
- Serious infection requiring oral or IV antibiotics and/or hospitalization
- Active tuberculosis
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California (USC); Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
Address:
City:
Santa Monica
Zip:
90404-2023
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale School of Medicine - Smilow Cancer Hospital - Yale-New Haven Hospital Location
Address:
City:
New Haven
Zip:
06519-1110
Country:
United States
Status:
Recruiting
Facility:
Name:
Georgetown University Medical Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus
Address:
City:
Detroit
Zip:
48201-2013
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Einstein Cancer Center
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center; Herbert Irving Pavilion Location
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania - Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104-4206
Country:
United States
Status:
Recruiting
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-8813
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109-4433
Country:
United States
Status:
Recruiting
Facility:
Name:
Klinikum Klagenfurt am Wörthersee
Address:
City:
Klagenfurt am Worthersee
Zip:
9020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Centre Georges Francois Leclerc (CGFL)
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Eugene Marquis (CEM)
Address:
City:
Rennes
Zip:
35042
Country:
France
Status:
Recruiting
Facility:
Name:
Assistance Publique-Hopitaux de Paris
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Medizinische Klinik und Poliklinik
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Gyeonggi-do
Zip:
13496
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Auckland District Health Board (ADHB); Auckland City Hospital (ACH)
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Hospital Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clínica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31620
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona (Hospital Clinic i Provincial); Barcelona Clinic Liver Cancer (BCLC)
Address:
City:
Barcelona
Zip:
8036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz.
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
70457
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Tainan
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei City
Zip:
112
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital (NTUH) - Cancer Research Center
Address:
City:
Zhongzheng Dist.
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Belfast Health and Social Care Trust - Belfast City Hospital
Address:
City:
Belfast
Zip:
BT9 7AB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Imperial College London - Imperial Centre for Translational and Experimental Medicine (ICTEM)
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Start date:
December 5, 2023
Completion date:
September 30, 2028
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05908786
