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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients in Remission to Reduce Recurrence Regardless of HPV Status

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: PepCan
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PepCan<br>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<br>* 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities<br>* Other names: PepCan Vaccine Regime;|
| Placebo Comparator: Placebo<br>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<br>* 0.9% Saline solution per dose administered intradermally in the extremities<br>* Other names: Placebo Vaccine Regimen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous cell carcinoma