Clinical Trials /

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

NCT03821272

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT03821272

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 217672
  • NCT ID: NCT03821272

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
PepCanHPV 16 E6 peptides combined with Candin®, PepCan Vaccine RegimePepCan
PlaceboSaline, Placebo Vaccine RegimenPlacebo

Purpose

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

      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.

Trial Arms

NameTypeDescriptionInterventions
PepCanExperimentalFour injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
  • PepCan
PlaceboPlacebo ComparatorFour injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
  • Placebo

Eligibility Criteria

        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
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events - evaluate safety of a 7-injection regimen of PepCan.
Time Frame:2 years
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan
Time Frame:2 years
Safety Issue:
Description:To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Arkansas

Trial Keywords

  • Squamous cell carcinoma

Last Updated

May 13, 2021