Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Able to provide informed consent 2. Male or female 18 years of age or older 3. Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) therapy within the previous 120 days 4. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 5. No Evidence of Disease (NED) based on clinical and/or radiographic evaluations 6. Vital Signs recorded 1. Blood pressure (≤160/95 mm Hg acceptable) 2. Heart rate (50-100 beats per min acceptable) 3. Respiratory rate (≥ 12 ≤25 breaths per min acceptable) 4. Temperature (≤100°F acceptable) 7. Blood work done at Screening Visit 1. White count (≥3x109/L acceptable) 2. Hemoglobin (≥ 7 g/dL acceptable) 8. Willing and able to comply with the requirements of the protocol

Exclusion Criteria

  1. Positive urine pregnancy test for women of childbearing potential 2. Being pregnant or attempting to be pregnant within the period of study participation 3. Women who are breast feeding or plan to breast feed within the period of study participation 4. Patients who are allergic to Candin® or yeast 5. History of severe asthma requiring emergency room visit or hospitalization within the past 5 years 6. Patients who have previously received PepCan 7. History of recurrence of squamous cell carcinoma of the head and neck 8. If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter or continue in this study

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PepCan
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
  • Biological: PepCan
    50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
    Other names:
    • HPV 16 E6 peptides combined with Candin®
    • PepCan Vaccine Regime
Placebo Comparator
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
  • Biological: Placebo
    0.9% Saline solution per dose administered intradermally in the extremities
    Other names:
    • Saline
    • Placebo Vaccine Regimen

Recruiting Locations

More Details

NCT ID
NCT03821272
Status
Active, not recruiting
Sponsor
University of Arkansas

Detailed Description

This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of PepCan (50 µg per peptide 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 by enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and 9), and by fluorescent activated cell sorter analysis will be made at times points at Visits 1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.