A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary endpoint added 4 → 5 primary endpoints
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Record History

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  1. Trial sites expanded: 33 → 39 locations
  2. Study sites: 34 to 35
  3. Study sites: 33 to 34
    • Study title revised
  4. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Site details revised at 6 of 33 sites
  5. Trial sites expanded: 30 → 33 locationsv27
  6. Primary endpoint(s) modifiedv26 Show 7 more changesShow less
    • Enrollment increased: 460 → 605 participants
    • Study completion pushed from Mar 27, 2029 to Feb 7, 2031
    • Interventions modified
    • Trial arms changed: 10 → 14
    • Eligibility criteria expanded, about 82 words
    • Secondary endpoints revised (6)
    • Site details revised at 1 of 30 sites
  7. Study sites: 29 to 30v25
  8. Study sites: 28 to 29v24
  9. Study sites: 27 to 28v23
  10. Study sites: 26 to 27v22
  11. Study sites: 24 to 26v21
  12. Study sites: 23 to 24v20
  13. Study sites: 22 to 23v19
  14. Study sites: 20 to 22v18
  15. Trial sites expanded: 17 → 20 locationsv17
  16. Enrollment increased: 280 → 460 participantsv16 Show 5 more changesShow less
    • Trial arms changed: 7 → 10
    • Study sites: 16 to 17
    • Interventions: Bevacizumab (Biological), Carboplatin (Drug), Paclitaxel (Drug), Pembrolizumab (Biological), Raludotatug Deruxtecan (Biological), Rescue… to Bevacizumab (Biological), Carboplatin (Drug), Gemcitabine (Drug), Paclitaxel (Drug), Pegylated liposomal doxorubicin (Drug), Pembrolizumab…
    • Eligibility criteria expanded, about 62 words
    • Study description shortened, about 1 word
  17. Site contacts updated at 1 of 16 sitesv15
  18. Re-verified, no change to tracked fieldsv14
  19. Study sites: 15 to 16v13
  20. Enrollment target: 78 to 280v12 Show 6 more changesShow less
    • Primary endpoints: 3 to 4
    • Interventions: Bevacizumab (Biological), Carboplatin (Drug), Paclitaxel (Drug), Raludotatug Deruxtecan (Biological) to Bevacizumab (Biological), Carboplatin (Drug), Paclitaxel (Drug), Pembrolizumab (Biological), Raludotatug Deruxtecan (Biological), Rescue…
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: 1 to 6
    • Study description expanded, about 36 words
    • Study arms: 3 to 7
  21. Study sites: 14 to 15v11
  22. Study sites: 12 to 14v10
  23. Study sites: 11 to 12v9
  24. Study sites: 10 to 11v8
  25. Study sites: 8 to 10v7
  26. Study sites: 7 to 8v6
  27. Study sites: 4 to 7v5
  28. Study sites: 1 to 4
    • Start date changed from estimate of Apr 11, 2025 to Apr 15, 2025
    v4
  29. Start date: Mar 27, 2025 to Apr 11, 2025v3
  30. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  31. 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.
Merck (MSD)
412 trials monitored
See 25 trials at risk
Ovarian Cancer
1,347 trials monitored
See 95 trials at risk
Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.
Trial Details
NCT Number NCT06843447
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions
(from sponsor)		 Ovarian Cancer Recurrent
Enrollment 605 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov