NCT03821272CompletedPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 23 Jan 2019
- Start date
- 13 Nov 2019
- Primary completion date
- 3 Feb 2025
- Lead sponsor
- University of Arkansas
- Diseases
- Head and neck cancer
- NCT number
- NCT03821272
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 17
- From 13 Nov 2019 to the primary completion date, 3 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received PepCan
Other illness
- Patients who are allergic to Candin® or yeast
- History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
- History of recurrence of squamous cell carcinoma of the head and neck
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.