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Head and Neck CancerPhase 1/2NCT03821272

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

A Phase 1/2 study testing PepCan in people with Head and Neck Cancer, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
PepCan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteUnited States
Study dates
13 Nov 2019to 3 Feb 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
PepCan, Placebo
Keywords
Squamous cell carcinoma
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PepCanBiological

    Also called HPV 16 E6 peptides combined with Candin®, PepCan Vaccine Regime

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

  • PlaceboBiological

    Also called Saline, Placebo Vaccine Regimen

    0.9% Saline solution per dose administered intradermally in the extremities

Study groups in NCT03821272
Study groupRoleWhat they receive
PepCanExperimentalFour injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
Receives: Biological: PepCan
PlaceboPlacebo comparatorFour injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (5)

  1. 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.

    Measured: Study completion, approximately 24 months after enrollment

  2. 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.

    Measured: Study completion, approximately 24 months after enrollment

  3. 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.

    Measured: Study completion, approximately 24 months after enrollment

  4. 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.

    Measured: Study completion, approximately 24 months after enrollment

  5. 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.

    Measured: Study completion, approximately 24 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start13 Nov 2019
  3. Primary completion3 Feb 2025
  4. Study completion3 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821272
Sponsor's protocol ID
217672
Status last verified
Sep 2025
First submitted
23 Jan 2019
Last updated
8 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bivens E, Atiq O, Evans T, Bimali M, Brown G, Crane J, Darwish N, Faulkner JL, Govindarajan R, Johnson A, Kurilung A, Lazarenko O, Lu YC, Marsh K, Moreno M, Nookaew I, Robeson M, Sunde J, Ussery D, Vural E, Wilman M, Nakagawa M. A Randomized Double-Blind Placebo-Controlled Phase I/II Clinical Trial of a Human Papillomavirus Therapeutic Vaccine, PepCan, for Reducing Head and Neck Cancer Recurrence. medRxiv [Preprint]. 2026 Jan 12:2026.01.09.26343801. doi: 10.64898/2026.01.09.26343801.

    PubMed 41646795

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PepCan in people with Head and Neck Cancer, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03821272, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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