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

University of Arkansas17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Head and Neck Cancer

Interventions

PepCanBIOLOGICAL

50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities

PlaceboBIOLOGICAL

0.9% Saline solution per dose administered intradermally in the extremities

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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.

Data from ClinicalTrials.gov

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