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A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients

NCT03821272 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-10-08

Study results available
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Summary

This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.

Conditions

Interventions

BIOLOGICAL

PepCan

50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities

BIOLOGICAL

Placebo

0.9% Saline solution per dose administered intradermally in the extremities

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Omar T Atiq, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2025-02-03
Completion
2025-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03821272 on ClinicalTrials.gov