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

Study acronym: ARTEMIDE-HCC01
StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 16, 2029 → Mar 15, 2030
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 219 → 226 locations
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 6 of 16 entries
  2. Primary completion pushed from Mar 16, 2029 to Mar 15, 2030
    • Study sites: 220 to 219
    v14
  3. Site details revised at 52 of 220 sitesv13
  4. Trial sites expanded: 217 → 220 locations
    • Site details revised at 3 of 220 sites
    v12
  5. Study sites: 217 to 220v11
  6. Trial sites expanded: 204 → 217 locations
    • Study completion date: Mar 14, 2030 to Mar 15, 2030
    • Eligibility criteria expanded, about 88 words
    • Secondary endpoints: 17 to 16
    v10
  7. Study sites: 196 to 204v9
  8. Study sites: 177 to 196v8
  9. Study sites: 161 to 177v7
  10. Study sites: 127 to 161v6
  11. Study sites: 113 to 127v5
  12. Study sites: 95 to 113v4
  13. Study sites: 85 to 95
    • Study completion date: Mar 15, 2030 to Mar 14, 2030
    v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 53 to 85
    • Start date changed from estimate of May 16, 2025 to May 6, 2025
    • Secondary endpoints: details revised at 1 of 17 entries
    v2
  15. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
729 trials monitored
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Liver Cancer
1,602 trials monitored
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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
Trial Details
NCT Number NCT06921785
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 1,220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov