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

NCT05952934 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 275695
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Assessment of clinical efficacy

  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.

  Through study completion, up to 2 years

Secondary Outcomes (1)

• Assessment of adverse events

  Regularly throughout the study, up to 2 years

Study Arms (2)

Candin vaccine

ACTIVE COMPARATOR

Seven Candida (Candin). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given.

Biological: 0.5 mL Candin®/injection

Placebo

PLACEBO COMPARATOR

Seven placebo injections (sterile 0.9% Normal Saline). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given.

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

Interventions

0.5 mL Candin®/injection BIOLOGICAL

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

Candin vaccine

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

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

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Male or female 18 years of age or older
• Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy and/or immunotherapy) within the 120 days prior to the screening visit
• No Evidence of Disease (NED) based on clinical and radiographic evaluations
• Willing and able to comply with the requirements of the protocol

You may not qualify if:

• Positive urine pregnancy test for women of childbearing potential
• Being pregnant or attempting to be pregnant with the period of study participation
• Women who are breast feeding or plan to breast feed within the period of study participation
• Patients who are allergic to Candin®
• If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study

Sponsors & Collaborators

• NYU Langone Health: collaborator
• University of Arkansas: lead
• Highlands Oncology Group, PA: collaborator

Study Sites (6)

Highlands Oncology Group, PA

Fayetteville, Arkansas, 72762, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Highlands Oncology Group, PA

Rogers, Arkansas, 75758, United States

RECRUITING

Highlands Oncology Group, PA

Springdale, Arkansas, 72762, United States

RECRUITING

Perlmutter Cancer Center at NYU Langone Health

Mineola, New York, 11501, United States

RECRUITING

Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Omar Atiq

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Trujillo

CONTACT

501-686-8274; MTrujillo@uams.edu

Aaron Holley

CONTACT

501-686-8274; jaholley@uams.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Each study site will received a separate randomization scheme, and the research pharmacy at each site will implement and maintain randomization schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 19, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (6)