Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PepCan | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PepCan
- description
- Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
- interventionNames
- Biological: PepCan
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
- interventionNames
- Biological: Placebo
Primary outcomes (1)
- measure
- Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBivens 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. PMID 41646795