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Completed

NCT Number: NCT03821272

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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) therapy within the previous 120 days
  • Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
  • No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
  • Vital Signs recorded
  • Blood pressure (≤160/95 mm Hg acceptable)
  • Heart rate (50-100 beats per min acceptable)
  • Respiratory rate (≥ 12 ≤25 breaths per min acceptable)
  • Temperature (≤100°F acceptable)
  • Blood work done at Screening Visit
  • White count (≥3x109/L acceptable)
  • Hemoglobin (≥ 7 g/dL acceptable)
  • Willing and able to comply with the requirements of the protocol

Exclusion criteria

  • Positive urine pregnancy test for women of childbearing potential
  • Being pregnant or attempting to be pregnant within 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® or yeast
  • History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
  • Patients who have previously received PepCan
  • History of recurrence of squamous cell carcinoma of the head and neck
  • 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

Treatment and study plan

PepCan

Biological

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

Biological

0.9% Saline solution per dose administered intradermally in the extremities

Other names: Saline, Placebo Vaccine Regimen

Primary outcomes

  1. Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.

    Time frame: 2 years

    To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.

Secondary outcomes

  1. Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan

    Time frame: Study completion, approximately 24 months after enrollment

    To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms. Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders.

  2. Efficacy Analysis (Intention to Treat) - PepCan

    Time frame: Study completion, approximately 24 months after enrollment

    Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis.

  3. Efficacy Analysis (Intention to Treat) - Placebo

    Time frame: Study completion, approximately 24 months after enrollment

    Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis.

  4. Efficacy Analysis (Per Protocol) - PepCan

    Time frame: Study completion, approximately 24 months after enrollment

    The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis.

  5. Efficacy Analysis (Per Protocol) - Placebo

    Time frame: Study completion, approximately 24 months after enrollment

    The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2019
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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