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

Официальное название

A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Обзор

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.

Подробное описание

This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Вмешательства

• Биопрепарат 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.
• Другое 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.

Первичные конечные точки

• Assessment of clinical efficacy [Срок оценки: Through study completion, up to 2 years]

Вторичные конечные точки (1)

• Assessment of adverse events [Срок оценки: Regularly throughout the study, up to 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Highlands Oncology Group, PA — Fayetteville
• University of Arkansas for Medical Sciences — Little Rock
• Highlands Oncology Group, PA — Rogers
• Highlands Oncology Group, PA — Springdale
• Perlmutter Cancer Center at NYU Langone Health — Mineola
• Perlmutter Cancer Center at NYU Langone Health — New York

Идентификаторы

NCT: NCT05952934 · 275695

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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