Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05952934 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2031 → Jul 31, 2032
See other at-risk trials from University of Arkansas

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Primary and study completion pushed from Jul 31, 2031 to Jul 31, 2032
    • Interventions: 0.5 mL Candin®/injection (Biological), Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) (Other) to 0.5 mL Candin®/injection (Biological), Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) (Other)
    • Eligibility criteria expanded, about 10 words
    • Site contacts updated at 2 of 6 sites
  3. Primary and study completion dates: Feb 1, 2029 to Jul 31, 2031
    • Eligibility criteria expanded, about 6 words
    • Site contacts updated at 2 of 6 sites
    v14
  4. Study sites: 1 to 6
    • Collaborators expanded, about 7 words
    v13
  5. Site contact updatedv12
Show 10 earlier versionsHide 10 earlier versions
  1. 4 versions Re-verified since Jun 20, 2024, no change to tracked fieldsv8-v11
  2. Primary completion date: Feb 2025 to Feb 1, 2029
    • Study completion date: Feb 2026 to Feb 1, 2029
    v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2024 to Feb 12, 2024
    • Site details revised
    v6
  4. Study sites: 0 to 1
    • Primary completion date: Jan 2025 to Feb 2025
    • Study completion date: Jan 2026 to Feb 2026
    • Start date: Jan 2024 to Feb 2024
    v5
  5. Primary completion date: Sep 2025 to Jan 2025
    • Study completion date: Sep 2026 to Jan 2026
    v4
  6. Start date: Sep 2023 to Jan 2024v3
  7. Start date: Jul 2023 to Sep 2023
    • Primary completion date: Jul 2025 to Sep 2025
    • Study completion date: Jul 2026 to Sep 2026
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 80 subjects are eligible for injection.
Trial Details
NCT Number NCT05952934
Lead Sponsor University of Arkansas
Collaborators: Highlands Oncology Group, PA, NYU Langone Health
Conditions
(from sponsor)		 Squamous Cell Carcinoma of Head and Neck
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov