Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer

Study acronym: DESTINY-BTC01
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 269 → 272 locations
    • Eligibility criteria shortened, about 36 words
    • Secondary endpoints: details revised at 16 of 27 entries
  2. Study sites: 270 to 269v22
  3. Site details revised at 6 of 270 sitesv21
  4. Site details revised at 8 of 270 sitesv20
  5. Trial sites expanded: 266 → 270 locationsv19
  6. Trial sites expanded: 263 → 266 locationsv18
  7. Study sites: 262 to 263v17
  8. Site details revised at 14 of 262 sitesv16
  9. Study sites: 260 to 262
    • Interventions: Agilent HercepTest™ mAb pharmDx (Diagnostic Test), Cisplatin (Drug), Durvalumab (Drug), Gemcitabine (Drug), Rilvegostomig (Drug)… to Cisplatin (Drug), Durvalumab (Drug), Gemcitabine (Drug), Rilvegostomig (Drug), Trastuzumab deruxtecan (Drug)
    v15
  10. Study sites: 255 to 260
    • Eligibility criteria expanded, about 184 words
    v14
  11. Re-verified, no change to tracked fieldsv13
  12. Study sites: 254 to 255v12
  13. Study sites: 248 to 254v11
  14. Study sites: 244 to 248v10
  15. Study sites: 224 to 244v9
  16. Study sites: 221 to 224v8
  17. Primary endpoints revised (2)
    • Study sites: 195 to 221
    • Secondary endpoints: 25 to 27
    v7
  18. Study sites: 179 to 195v6
  19. Study sites: 172 to 179v5
  20. Study sites: 145 to 172v4
  21. Study sites: 91 to 145
    • Secondary endpoints: details revised at 2 of 25 entries
    • Collaborators shortened, about 2 words
    v3
  22. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 36 to 91
    • Primary completion date: Apr 26, 2028 to Jun 12, 2028
    • Study completion date: Mar 30, 2029 to May 16, 2029
    • Start date changed from estimate of Jun 26, 2024 to Aug 12, 2024
  23. 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.
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
Trial Details
NCT Number NCT06467357
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 Biliary Tract Cancer
Related terms Biliary Tract Neoplasms
Enrollment 620 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov