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Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
Trial Status: active
This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global
study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab
with or without tremelimumab compared to atezolizumab in combination with bevacizumab.
This study will be conducted in participants with advanced HCC who are not amenable to
curative therapy or locoregional therapy
Inclusion Criteria
Inclusion Criteria:
- Locally advanced or metastatic and/or unresectable HCC
- WHO/ECOG performance status of 0 or 1
- BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh
Score class A
- At least one measurable target lesion
- co-infected with HBV and HCV are not eligible
- Adequate organ and bone marrow function measured during the screening period
- Must not have received prior systemic therapy for intermediate, advanced, or
metastatic HCC.
- Disease that is not amenable to curative surgical and/or locoregional therapies. For
participants who received locoregional therapy for HCC, locoregional therapy must
have been completed ≥ 28 days prior to the baseline scan for the current study.
Exclusion Criteria:
Medical condition
- Any evidence of uncontrolled intercurrent diseases
- Active or prior documented autoimmune or inflammatory disorders requiring chronic
treatment with steroids or other immunosuppressive treatment
- History of another primary malignancy
- Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not
yet improved to Grade ≤ 1 or baseline.
- Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring
non-pharmacologic intervention to maintain symptomatic control within 6 months prior
to the first scheduled dose.
- History of active primary immunodeficiency or active infection
- History of hepatic encephalopathy
- Current or recent (within 10 days of first dose of study treatment) use of aspirin
(≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and
cilostazol
- Current or recent (within 10 days prior to study treatment start) use of full-dose
oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed
to prophylactic) purposes is ineligible
Bleeding or other risks
HCC related
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- Central nervous system metastases or spinal cord compression (including asymptomatic
and adequately treated disease)
- Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
- Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior
to initiation of study treatment, except palliative radiotherapy to bone lesions
within 7 days prior to initiation of study treatment
Additional locations may be listed on ClinicalTrials.gov for NCT06921785.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
The purpose of this study is to assess the efficacy and tolerability of rilvegostomig in
combination with bevacizumab with or without tremelimumab as first-line treatment in
participants with advanced HCC. The study comprises 2 parts - a safety lead-in and a
randomised period. Prior to the start of the randomised period of the study, a single-arm
safety lead-in period will be applied to evaluate the safety and tolerability of
rilvegostomig in combination with bevacizumab and tremelimumab.