A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

Record status This record was last updated September 10, 2026 (before its estimated October 19, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Study sites: 36 to 37
    • Primary and study completion dates: Oct 31, 2026 to Oct 19, 2026
    v34
  2. Study sites: 37 to 36v33
  3. Study sites: 38 to 37
    • Primary and study completion dates: Dec 18, 2026 to Oct 31, 2026
    v32
  4. Study sites revised (38)v31
  5. Primary and study completion dates: Dec 24, 2026 to Dec 18, 2026v30
Show 28 earlier versionsHide 28 earlier versions
  1. Re-verified, no change to tracked fieldsv29
  2. Study sites: 60 to 38v28
  3. Enrollment target: estimated 160 to confirmed 83
    • Study sites: 75 to 60
    • Secondary endpoints: 7 to 3
    v27
  4. Study sites: 109 to 75v26
  5. Primary and study completion dates pushed to Dec 24, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 110 to 109
    v25
  6. Re-verified, no change to tracked fieldsv24
  7. Study sites: 109 to 110v23
  8. Site details revised at 1 of 109 sitesv22
  9. Study sites: 107 to 109v21
  10. Study sites: 105 to 107v20
  11. Study sites: 101 to 105v19
  12. Study sites: 86 to 101v18
  13. Study sites: 71 to 86v17
  14. Study sites: 56 to 71v16
  15. Study sites: 48 to 56v15
  16. Study sites: 39 to 48v14
  17. Site details revised at 2 of 39 sitesv13
  18. Study sites: 38 to 39v12
  19. Study sites: 36 to 38v11
  20. Study sites: 34 to 36
    • Secondary endpoints: details revised at 5 of 7 entries
    v10
  21. Study sites: 31 to 34v9
  22. Interventions: Nab-Paclitaxel (Drug), Pembrolizumab (Drug), RO7247669 (Drug) to Nab-Paclitaxel (Drug), Pembrolizumab (Drug), Tobemstomig (Drug)
    • Eligibility criteria revised
    • Secondary endpoints revised (7)
    • Study title revised
    v8
  23. Study sites: 22 to 31v7
  24. Study sites: 19 to 22v6
  25. Study sites: 15 to 19v5
  26. Study sites: 5 to 15
    • Start date changed from estimate of Jul 3, 2023 to Jul 18, 2023
    v4
  27. Study sites: 1 to 5
    • Start date: Jun 29, 2023 to Jul 3, 2023
    v3
  28. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 30, 2023 to Jun 29, 2023
    • Study sites: 0 to 1
    v2
  1. 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.
Roche/Genentech
369 trials monitored
See 29 trials at risk
Breast Cancer
5,481 trials monitored
See 311 trials at risk
The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or metastatic (Stage IV) programmed death-ligand 1 (PD-L1)-positive triple-negative breast cancer (TNBC).
Trial Details
NCT Number NCT05852691
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov