Health Trials

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

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tremelimumab

    Drug

    IV therapy

  • Rilvegostomig

    Drug

    IV therapy

  • Bevacizumab

    Drug

    IV therapy

  • Atezolizumab

    Drug

    IV therapy

Treatment groups

1,220 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 3 interventions
Group B: Arm BExperimental treatment 2 interventions
Group C: Arm CActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCC

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Up to approximately 6 years

Secondary outcomes

1

To demonstrate the efficacy of Arm B relative to Arm C by assessment of OS in participants with advanced HCC

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Up to approximately 6 years
2

To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relative to Arm C in participants with advanced HCC

PFS according to RECIST 1.1

Time frame
Up to approximately 6 years
3

To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relative to Arm C in participants with advanced HCC

ORR according to RECIST 1.1

Time frame
Up to approximately 6 years
4

To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relative to Arm C in participants with advanced HCC

DoR according to RECIST 1.1

Time frame
Up to approximately 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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