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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Biological: PepCan; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan	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.	Study completion, approximately 24 months after enrollment
Efficacy Analysis (Intention to Treat) - PepCan	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.	Study completion, approximately 24 months after enrollment
Efficacy Analysis (Intention to Treat) - Placebo	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.	Study completion, approximately 24 months after enrollment
Efficacy Analysis (Per Protocol) - PepCan	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.	Study completion, approximately 24 months after enrollment
Efficacy Analysis (Per Protocol) - Placebo	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.	Study completion, approximately 24 months after enrollment

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Omar T Atiq, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 3, 2025

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Squamous cell carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: 217672

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No