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

NCT03821272 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 217672
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Cancer

Keywords

Squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan

  Study completion, approximately 24 months after enrollment

• Efficacy Analysis (Intention to Treat) - PepCan

  Study completion, approximately 24 months after enrollment

• Efficacy Analysis (Intention to Treat) - Placebo

  Study completion, approximately 24 months after enrollment

• Efficacy Analysis (Per Protocol) - PepCan

  Study completion, approximately 24 months after enrollment

• Efficacy Analysis (Per Protocol) - Placebo

  Study completion, approximately 24 months after enrollment

Study Arms (2)

PepCan

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

PepCan BIOLOGICAL

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

Also known as: HPV 16 E6 peptides combined with Candin®, PepCan Vaccine Regime

PepCan

Placebo BIOLOGICAL

0.9% Saline solution per dose administered intradermally in the extremities

Also known as: Saline, Placebo Vaccine Regimen

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Mayumi Nakagawa, M.D., Ph.D.
• Organization: University of Arkansas for Medical Sciences

MNakagawa@uams.edu

(501) 686-8635

Study Officials

• Omar T Atiq, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 29, 2019
• Study Start: November 13, 2019
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Locations

US (1)