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

NCT06921785
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,220
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Lead sponsor
AstraZeneca
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Start date
2025-05-06
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Number of sites
220
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Summary
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
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Acronym
ARTEMIDE-HCC01
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Short title
Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
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Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-03-15
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First posted
2025-04-10
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Registry last updated
2026-07-14
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Primary completion date
2029-03-16
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Start date
2025-05-06
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Participants
1,220
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Participant count basis
Estimated
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Planned participants
1,220
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Protocol amendments
2
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Number of sites
220
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06921785
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ClinicalTrials.gov ID
NCT06921785
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masking description
The study will be conducted "Sponsor-blinded", Sponsor personnel directly involved in the study conduct will not have access to efficacy data aggregated by intervention arm prior to study unbinding.
Masked roles
Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Up to approximately 6 years

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

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

    Timeframe: Up to approximately 6 years

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

  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

    Timeframe: Up to approximately 6 years

    PFS according to RECIST 1.1

  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

    Timeframe: Up to approximately 6 years

    ORR according to RECIST 1.1

  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

    Timeframe: Up to approximately 6 years

    DoR according to RECIST 1.1

  5. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    Timeframe: Up to approximately 6 years

    OS

  6. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    Timeframe: Up to approximately 6 years

    PFS

  7. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    Timeframe: Up to approximately 6 years

    ORR

  8. To demonstrate the efficacy of Arm A relative to Arm B in participants with advanced HCC

    Timeframe: Up to approximately 6 years

    DoR

  9. To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups

    Timeframe: Up to approximately 6 years

    Association of PD-L1 expression level with: • OS

  10. To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups

    Timeframe: Up to approximately 6 years

    Association of PD-L1 expression level with: • PFS per RECIST 1.1

  11. To demonstrate the efficacy of Arm A relative to Arm C in the population defined by PD-L1 expression subgroups

    Timeframe: Up to approximately 6 years

    Association of PD-L1 expression level with: • ORR per RECIST 1.1

  12. To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups

    Timeframe: Up to approximately 6 years

    Association of PD-L1 expression level with: OS

  13. To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups

    Timeframe: Up to approximately 6 years

    Association of PD-L1 expression level with: PFS per RECIST 1.1

  14. To demonstrate the efficacy of Arm B relative to Arm C in the population defined by PD-L1 expression subgroups

    Timeframe: Up to approximately 6 years

    Association of PD-L1 expression level with: ORR per RECIST 1.1

  15. To investigate the immunogenicity of Arm A and Arm B

    Timeframe: Up to approximately 6 years

    Presence of ADAs for tremelimumab and rilvegostomig

  16. Occurrence of adverse events (AEs) and serious adverse events (SAEs)

    Timeframe: Up to approximately 6 years

    Occurrence of AEs and SAEs will be graded according to the revised NCI CTCAE v5.0.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

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
  • History of significant bleeding disorders, vasculitis, or a significant bleeding episode from the GI tract within 6 months prior to study randomization.
  • Participants with untreated or incompletely treated varices with bleeding or high-risk (red wale signs or other high-risk factors) for bleeding.

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
Sources for eligibility
clinicaltrials.gov

  • Research SitePhoenix, United StatesRecruiting
  • Research SiteTucson, United StatesRecruiting
  • Research SiteLos Angeles, United StatesNot yet recruiting
  • Research SitePalo Alto, United StatesRecruiting
  • Research SiteNew Haven, United StatesRecruiting
  • Research SiteNewark, United StatesRecruiting
  • Research SiteJacksonville, United StatesRecruiting
  • Research SiteAtlanta, United StatesRecruiting
  • Research SiteAtlanta, United StatesWithdrawn
  • Research SiteHonolulu, United StatesWithdrawn
  • Research SiteChicago, United StatesNot yet recruiting
  • Research SiteIndianapolis, United StatesNot yet recruiting
  • Research SiteShreveport, United StatesNot yet recruiting
  • Research SiteDetroit, United StatesNot yet recruiting
  • Research SiteGrand Rapids, United StatesRecruiting
  • Research SiteRochester, United StatesRecruiting
  • Research SiteSt Louis, United StatesNot yet recruiting
  • Research SiteNew Brunswick, United StatesRecruiting
  • Research SiteNew York, United StatesRecruiting
  • Research SiteNew York, United StatesNot yet recruiting
  • Research SiteNew York, United StatesNot yet recruiting
  • Research SiteCleveland, United StatesWithdrawn
  • Research SiteOklahoma City, United StatesNot yet recruiting
  • Research SitePhiladelphia, United StatesNot yet recruiting
  • Research SitePittsburgh, United StatesRecruiting

And 195 more, listed on the interactive page.

Sources for sites
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Related records

Drugs (4)

Lead sponsors (1)

Conditions (1)

Targets (3)