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Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.

Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.

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

PepCan

0.9% Saline solution per dose administered intradermally in the extremities

Placebo

Omar T Atiq, MD

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.

PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.

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

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.

To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients	NCT03821272	Head and Neck C...	PepCan Placebo	18 Years - 100 Years	University of Arkansas
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients	NCT03821272	Head and Neck C...	PepCan Placebo	18 Years - 100 Years	University of Arkansas
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients	NCT03821272	Head and Neck C...	PepCan Placebo	18 Years - 100 Years	University of Arkansas

Spots Global Cancer Trial Database for pepcan

Every month we try and update this database with for pepcan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pepcan

Every month we try and update this database with for pepcan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pepcan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.