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A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc. Trial sites expanded: 66 → 92 locations · Interventions: Bevacizumab (Drug), Precemtabart tocentecan (Drug), Trifluridine/Tipiracil (FTD-TPI) (Drug) to Bevacizumab (Drug), Precemtabart tocentecan (Drug), Trifluridine/Tipiracil (FTD-TPI) (Drug) · Eligibility criteria expanded, about 11 words · 1 more Show 4 more changesShow less
    • Trial sites expanded: 66 → 92 locations
    • Interventions: Bevacizumab (Drug), Precemtabart tocentecan (Drug), Trifluridine/Tipiracil (FTD-TPI) (Drug) to Bevacizumab (Drug), Precemtabart tocentecan (Drug), Trifluridine/Tipiracil (FTD-TPI) (Drug)
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 9 entries
  2. Trial sites expanded: 34 → 66 locationsv6
  3. Trial sites expanded: 21 → 34 locationsv5
  4. Trial sites expanded: 8 → 21 locationsv4
  5. Trial sites expanded: 3 → 8 locationsv3
  6. Primary completion pushed from Dec 25, 2028 to Oct 16, 2029 Recruitment opened · Study sites: 2 to 3 · Completion date: Oct 31, 2029 to Oct 16, 2029 · 2 morev2 Show 5 more changesShow less
    • Recruitment opened
    • Study sites: 2 to 3
    • Completion date: Oct 31, 2029 to Oct 16, 2029
    • Start date changed from estimate of May 5, 2026 to May 6, 2026
    • Secondary endpoints: details revised at 4 of 9 entries
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Merck KGaA
43 trials monitored
See 4 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluridine/tipiracil (FTD-TPI) plus bevacizumab.
Trial Details
NCT Number NCT07549412
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Metastatic Colorectal Cancer
Enrollment 1,020 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov