Phase 2
N=17
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03821272 ↗Enrolled (actual)
17
Serious AEs
41.2%
Results posted
Oct 2025
Primary outcome: Primary: Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan. — 23; 0; 0; 1 adverse event
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PepCan (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan. |
23; 0; 0; 1; 2; 0 | — |
| SECONDARY Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan |
5; 4; 4; 1; 2; 0 | — |
| SECONDARY Efficacy Analysis (Intention to Treat) - PepCan |
5; 6; 1 | 0.31 |
| SECONDARY Efficacy Analysis (Intention to Treat) - Placebo |
4; 1; 0 | 0.31 |
| SECONDARY Efficacy Analysis (Per Protocol) - PepCan |
5; 4; 3 | 0.58 |
| SECONDARY Efficacy Analysis (Per Protocol) - Placebo |
4; 1; 0 | 0.58 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03821272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.