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

NCT05952934 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-08

No results posted yet for this 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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

BIOLOGICAL

0.5 mL Candin®/injection

Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

OTHER

Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)

Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Sponsors & Collaborators

  • Highlands Oncology Group, PA

    collaborator UNKNOWN

  • NYU Langone Health

    collaborator OTHER

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Omar Atiq · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2031-07-31
Completion
2031-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05952934 on ClinicalTrials.gov