Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06337695 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 1 month later Nov 1, 2026 → Dec 1, 2030
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 88% 298 → 36 participants
See other at-risk trials from AHS Cancer Control Alberta

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Nov 1, 2026 to Dec 1, 2030v3 Show 10 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 298 → 36 participants
    • Sponsor changed: University of Calgary to AHS Cancer Control Alberta
    • Recruitment opened
    • Start date changed from estimate of Jul 1, 2024 to Aug 13, 2026
    • Study completion pushed from Dec 1, 2026 to Dec 1, 2030
    • Eligibility criteria expanded, about 167 words
    • Secondary endpoints: 16 to 9
    • Study description expanded, about 41 words
    • Study title shortened, about 3 words
  2. Secondary endpoints revised (16)
    • Study title shortened, about 6 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICI) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy
Trial Details
NCT Number NCT06337695
Lead Sponsor AHS Cancer Control Alberta
Conditions
(from sponsor)		 IrAE, Immune-related Adverse Event, Diarrhea, Colitis
Related terms Colitis, Diarrhea
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov