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

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.

Timeline

Start

2019-11-13

Primary completion

2025-02-03

Completion

2025-02-03

Outcome

Missed primary endpoint

paper These differences were not statistically significant. PMID 41646795 ↗

paper PepCan does not seem to be effective in reducing recurrence; however, the results are inconclusive given the small patient numbers. PMID 41646795 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PepCan	Vaccine	50 ug	Other
Subject	PepCan	Vaccine	0.3 ml	Other

Indications