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Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site details revised at 3 of 46 sitesv21
  2. Minor Trial status changed: Recruiting → Active, Not Recruiting Trial sites reduced: 60 → 46 locationsv20 Show 1 more changeShow less
    • Trial sites reduced: 60 → 46 locations
  3. Minor 2 versions Re-verified since Feb 16, 2026, no change to tracked fieldsv18-v19
  4. Notable Primary completion date: Dec 31, 2025 to Oct 27, 2026 Enrollment target: 260 to 294 · Study sites: 61 to 60 · Completion date: Dec 14, 2026 to Oct 28, 2027 · 1 morev17 Show 4 more changesShow less
    • Enrollment target: 260 to 294
    • Study sites: 61 to 60
    • Completion date: Dec 14, 2026 to Oct 28, 2027
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  5. Minor 2 versions Re-verified since May 29, 2025, no change to tracked fieldsv15-v16
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Site details revised at 1 of 61 sitesv14
  2. Minor Site details revised at 1 of 61 sitesv13
  3. Minor Completion date: Jan 26, 2027 to Dec 14, 2026 Site details revised at 1 of 61 sitesv12 Show 1 more changeShow less
    • Site details revised at 1 of 61 sites
  4. Minor Primary completion date: Nov 27, 2025 to Dec 31, 2025 Completion date: Dec 14, 2026 to Jan 26, 2027 · Site details revised at 1 of 61 sitesv11 Show 2 more changesShow less
    • Completion date: Dec 14, 2026 to Jan 26, 2027
    • Site details revised at 1 of 61 sites
  5. Minor Study sites: 60 to 61v10
  6. Minor Study sites: 59 to 60 Primary completion date: Nov 26, 2025 to Nov 27, 2025 · Completion date: Nov 25, 2026 to Dec 14, 2026v9 Show 2 more changesShow less
    • Primary completion date: Nov 26, 2025 to Nov 27, 2025
    • Completion date: Nov 25, 2026 to Dec 14, 2026
  7. Minor Re-verified, no change to tracked fieldsv8
  8. Minor Site details revised at 2 of 59 sitesv7
  9. Notable Primary completion date: Nov 8, 2024 to Nov 26, 2025 Enrollment target: 180 to 260 · Study sites: 58 to 59 · Completion date: Nov 11, 2025 to Nov 25, 2026 · 3 morev6 Show 6 more changesShow less
    • Enrollment target: 180 to 260
    • Study sites: 58 to 59
    • Completion date: Nov 11, 2025 to Nov 25, 2026
    • Interventions: AZD2936 (Drug), Bevacizumab (Drug), Cisplatin (Drug), Gemcitabine (Drug), Lenvatinib (Drug), MEDI5752 (Drug) to Bevacizumab (Drug), Cisplatin (Drug), Gemcitabine (Drug), Lenvatinib (Drug), Rilvegostomig (Drug), Volrustomig (Drug)
    • Study arms: 5 to 7
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Study sites: 57 to 58v5
  11. Minor Study sites: 55 to 57v4
  12. Notable Enrollment target: 120 to 180 Primary endpoints: 2 to 3 · Study sites: 47 to 55 · Primary completion date: Nov 11, 2024 to Nov 8, 2024 · 6 morev3 Show 9 more changesShow less
    • Primary endpoints: 2 to 3
    • Study sites: 47 to 55
    • Primary completion date: Nov 11, 2024 to Nov 8, 2024
    • Completion date: Nov 12, 2025 to Nov 11, 2025
    • Interventions: Bevacizumab (Drug), Lenvatinib (Drug), MEDI5752 (Drug) to AZD2936 (Drug), Bevacizumab (Drug), Cisplatin (Drug), Gemcitabine (Drug), Lenvatinib (Drug), MEDI5752 (Drug)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 34 words
    • Study arms: 3 to 5

    See this version in full on ClinicalTrials.gov ↗

  13. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 45 to 47 · Primary completion date: Oct 28, 2024 to Nov 11, 2024 · Completion date: Oct 27, 2025 to Nov 12, 2025 · 1 morev2 Show 4 more changesShow less
    • Study sites: 45 to 47
    • Primary completion date: Oct 28, 2024 to Nov 11, 2024
    • Completion date: Oct 27, 2025 to Nov 12, 2025
    • Start date changed from estimate of Apr 6, 2023 to Apr 24, 2023
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
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GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
Trial Details
NCT Number NCT05775159
Lead Sponsor AstraZeneca
Conditions Hepatocellular Carcinoma, Biliary Tract Cancer
Enrollment 294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov