Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

A vizsgálat adatai

Ki végzi

AstraZeneca

Azonosító

NCT06921785EU 2024-518210-81-00

A regiszteradat frissítve

2026. október 13.

Eredeti leírás

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 therapyA teljes eredeti leírásKevesebb

A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

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

Bevonási feltételek: 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; Participants with active HBV infection must receive antiviral therapy for a minimum of 14 days prior to randomization to show evidence of HBV stabilization or signs of viral response; Participants with active HCV infection must be well controlled. Participants co-infected with HBV and HCV are not eligible; Adequate organ and bone marrow function measured during the screening period; 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.

Kizáró feltételek: Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment; 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; 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; History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 6 months prior to study randomization; 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; Medical condition; Any evidence of uncontrolled intercurrent diseases; History of another primary malignancy; History of active primary immunodeficiency or active infection; History of hepatic encephalopathy; Participants with untreated or incompletely treated varices with bleeding or high-risk (red wale signs or other high-risk factors) for bleeding; HCC related; Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease); Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

ClinicalTrials.gov NCT06921785 · EU CTIS 2024-518210-81-00