A Phase 1/2 interventional study of PepCan and Placebo in Head and Neck Cancer, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by University of Arkansas · Phase 1/2, Interventional, and Treatment
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 17 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Vital Signs recorded
Blood work done at Screening Visit
Exclusion Criteria:
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
Biological: PepCan
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Biological: Placebo
50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
Also known as: HPV 16 E6 peptides combined with Candin®, PepCan Vaccine Regime
0.9% Saline solution per dose administered intradermally in the extremities
Also known as: Saline, Placebo Vaccine Regimen
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.
Time frame: 2 years
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.
Time frame: Study completion, approximately 24 months after enrollment
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.
Time frame: Study completion, approximately 24 months after enrollment
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.
Time frame: Study completion, approximately 24 months after enrollment
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.
Time frame: Study completion, approximately 24 months after enrollment
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.
Time frame: Study completion, approximately 24 months after enrollment
| Milestone | PepCan | Placebo |
|---|---|---|
| Started | 12 | 5 |
| Completed | 9 | 5 |
| Not completed | 3 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| adverse event | PepCan | Placebo |
|---|---|---|
| General Disorders and Site Administration Conditions: Injection site reaction | 23 | 0 |
| General Disorders and Site Administration Conditions: Fatigue | 0 | 1 |
| Immune System Disorders : Allergic reaction | 2 | 0 |
| Injury, Poisoning and Procedural Complications : Vaccination complication | 4 | 1 |
| Metabolism and Nutrition Disorders: Hypokalemia | 1 | 0 |
| Nervous System Disorders : Dizziness | 1 | 0 |
| Nervous System Disorders : Headache | 2 | 0 |
| Skin and Subcutaneous Tissue Disorders : Pruritus | 1 | 0 |
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.
| Participants | PepCan | Placebo |
|---|---|---|
| Non-recurrence | 5 | 4 |
| Recurrence | 4 | 1 |
| Withdrawn | 2 | 0 |
| Ineligible | 1 | 0 |
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.
| Participants | PepCan |
|---|---|
| Responder | 5 |
| Non-responder | 6 |
| Unknown | 1 |
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.
| Participants | Placebo |
|---|---|
| Responder | 4 |
| Non-responder | 1 |
| Unknown | 0 |
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.
| Participants | PepCan |
|---|---|
| Responder | 5 |
| Non-responder | 4 |
| Unknown | 3 |
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.
| Participants | Placebo |
|---|---|
| Responder | 4 |
| Non-responder | 1 |
| Unknown | 0 |
Collected over Approximately 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PepCan | 1/12 (8.3%) | 5/12 (41.7%) | 12/12 (100%) |
| Placebo | 0/5 (0%) | 2/5 (40%) | 5/5 (100%) |
| Event | PepCan | Placebo |
|---|---|---|
| ConstipationGastrointestinal disorders | 0/12 | 1/5 |
| Upper gastrointestinal hemorrhageGastrointestinal disorders | 0/12 | 1/5 |
| Urinary tract obstructionRenal and urinary disorders | 0/12 | 1/5 |
| Surgical and medical procedures - Other, specifySurgical and medical procedures | 2/12 | 1/5 |
| Vascular disorders - Other, specifyVascular disorders | 0/12 | 1/5 |
| DiarrheaGastrointestinal disorders | 1/12 | 0/5 |
| VomitingGastrointestinal disorders | 1/12 | 0/5 |
| Gastrointestinal disorders - Other, specifyGastrointestinal disorders | 1/12 | 0/5 |
| Gait disturbanceGeneral disorders | 1/12 | 0/5 |
| BacteremiaInfections and infestations | 1/12 | 0/5 |
| Event | PepCan | Placebo |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 10/12 | 5/5 |
| Dry mouthGastrointestinal disorders | 10/12 | 5/5 |
| HypoalbuminemiaMetabolism and nutrition disorders | 4/12 | 5/5 |
| HyponatremiaMetabolism and nutrition disorders | 6/12 | 5/5 |
| Lymphocyte count decreasedInvestigations | 11/12 | 5/5 |
| Injection site reactionGeneral disorders | 10/12 | 0/5 |
| DysphagiaGastrointestinal disorders | 9/12 | 4/5 |
| FatigueGeneral disorders | 8/12 | 4/5 |
| Investigations - Other, specifyInvestigations | 9/12 | 3/5 |
| HyperglycemiaMetabolism and nutrition disorders | 8/12 | 2/5 |
| Age, Continuous(years) | PepCan | Placebo | Total |
|---|---|---|---|
| Mean | 60.03 ± 8.30 | 59.34 ± 14.00 | 59.82 ± 9.82 |
| Sex: Female, Male(Participants) | PepCan | Placebo | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 11 | 4 | 15 |
| Ethnicity (NIH/OMB)(Participants) | PepCan | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 11 | 5 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PepCan | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 0 | 4 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | PepCan | Placebo | Total |
|---|---|---|---|
| United States | 12 | 5 | 17 |
| White blood cells(10^3 cells/μL) | PepCan | Placebo | Total |
|---|---|---|---|
| Mean | 5.20 ± 1.52 | 4.64 ± 1.70 | 5.03 ± 1.55 |
| Hemoglobin(g/dL) | PepCan | Placebo | Total |
|---|---|---|---|
| Mean | 11.94 ± 1.91 | 10.88 ± 1.43 | 11.63 ± 1.81 |
| Hematocrit(%) | PepCan | Placebo | Total |
|---|---|---|---|
| Mean | 36.63 ± 5.73 | 32.96 ± 4.64 | 35.55 ± 5.56 |
8 further baseline measures are reported on the registry.
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