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

PHASE3RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Locally advanced or metastatic and/or unresectable HCC
  2. WHO/ECOG performance status of 0 or 1
  3. BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A
  4. At least one measurable target lesion
  5. Adequate organ and bone marrow function measured during the screening period
  6. 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

  1. Any evidence of uncontrolled intercurrent diseases
  2. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
  3. History of another primary malignancy
  4. Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
  5. 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.
  6. History of active primary immunodeficiency or active infection
  7. History of hepatic encephalopathy
  8. 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
  9. 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
  10. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  11. Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
  12. Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
  13. 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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT06921785

Intervention or treatment

DRUG: Tremelimumab

DRUG: Rilvegostomig

DRUG: Bevacizumab

DRUG: Atezolizumab

Conditions

  • Hepatocellular Carcinoma

  • Condition: Hepatocellular Carcinoma

  • DRUG: Tremelimumab and other drugs

  • Auchenflower, Australia and more

  • Sponsor: AstraZeneca

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Research Site

Select from list below to view details:

  • Research Site

    Auchenflower, Australia

  • Research Site

    Camperdown, Australia

  • Research Site

    Heidelberg, Australia

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Who is running the clinical trial?

A

AstraZeneca

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Arm A
  • Tremelimumab , rilvegostomig and bevacizumab
Drug: Tremelimumab, Drug: Rilvegostomig, Drug: Bevacizumab
    EXPERIMENTAL: Arm B
    • Rilvegostomig, and bevacizumab
    Drug: Rilvegostomig, Drug: Bevacizumab
      ACTIVE_COMPARATOR: Arm C
      • Atezolizumab, and bevacizumab
      Drug: Bevacizumab, Drug: Atezolizumab

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        To demonstrate the efficacy of Arm A relative to Arm C by assessment of OS in participants with advanced HCCOS is defined as the time from randomisation until the date of death due to any cause.Up to approximately 6 years

        Secondary Outcome

        MeasureDescriptionTime Frame
        To demonstrate the efficacy of Arm B relative to Arm C by assessment of OS in participants with advanced HCCOS is defined as the time from randomisation until the date of death due to any cause.Up to approximately 6 years
        To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relateive to Arm C in participants with advanced HCCPFS according to RECIST 1.1Up to approximately 6 years
        To further demonstrate the efficacy of Arm A relative to Arm C and Arm B relateive to Arm C in participants with advanced HCCORR according to RECIST 1.1Up to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCCOSUp to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCCPFSUp to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCCORRUp to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCCDoRUp to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: • OSUp to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: • PFS per RECIST 1.1Up to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: • ORR per RECIST 1.1Up to approximately 6 years
        To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: •DoR per RECIST 1.1Up to approximately 6 years
        To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: OSUp to approximately 6 years
        To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: PFS per RECIST 1.1Up to approximately 6 years
        To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: ORR per RECIST 1.1Up to approximately 6 years
        To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroupsAssociation of PD-L1 expression level with: DoR per RECIST 1.1Up to approximately 6 years
        To investigate the immunogenicity of Arm A and Arm BPresence of ADAs for tremelimumab and rilvegostomigUp to approximately 6 years
        Occurrence of adverse events (AEs) and serious adverse events (SAEs)Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.Up to approximately 6 years
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

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

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