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NCT05952934 · ClinicalTrials.gov registry record · Phase 2
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
A Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Arkansas.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 6
- Study locations
NCT05952934: Recruiting Phase 2 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Arkansas.
NCT05952934 is a Phase 2 study of Squamous Cell Carcinoma of Head and Neck that is actively recruiting participants, run by University of Arkansas. The registered enrollment target is 100 participants, below the 168-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (40% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05952934, a Phase 2 study of Squamous Cell Carcinoma of Head and Neck, is actively recruiting participants, sponsored by University of Arkansas.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint.
Conditions Studied
Interventions
- BIOLOGICAL 0.5 mL Candin®/injection
- OTHER Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Study Locations (6)
Arkansas
- Highlands Oncology Group, PA - Fayetteville
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group, PA - Rogers
- Highlands Oncology Group, PA - Springdale
New York
- Perlmutter Cancer Center at NYU Langone Health - Mineola
- Perlmutter Cancer Center at NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-02-12 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 2 |
What NCT05952934 shows while recruiting
NCT05952934 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 168-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which 0.5 mL Candin®/injection is the first listed.
NCT05952934 lists 6 locations in 2 states (Arkansas, New York).
Frequently Asked Questions
What is clinical trial NCT05952934 about?
NCT05952934 is a clinical study titled "Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence". 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 pl...
What is the current status of trial NCT05952934?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-02-12. Estimated completion is 2029-02-01.
What conditions does trial NCT05952934 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT05952934?
The interventions under investigation include: 0.5 mL Candin®/injection (BIOLOGICAL), Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) (OTHER).
Who is sponsoring clinical trial NCT05952934?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05952934 being conducted?
This trial has 6 study locations across Arkansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma of Head and Neck
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Where NCT05952934's enrollment target sits among peer trials
100 16th of 37 higher than 22 of 37 other Squamous Cell Carcinoma of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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