PepCan for Head and Neck Cancer

Overseen By Omar Atiq, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Arkansas

Disqualifiers: Pregnancy, Breastfeeding, Severe asthma, others

Compensation: Varies

Number of Visits: 10

Duration: 24 months

17 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Omar T Atiq, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

Adults over 18 who've had squamous cell carcinoma of the head and neck, are now in remission after curative therapy, and have a stable health status (specific vital signs and blood counts). Excluded are those with severe recent asthma issues, past cancer recurrence, pregnant or breastfeeding women, yeast allergy sufferers, or previous PepCan recipients.

Inclusion Criteria

White count (≥3x109/L acceptable)

I am able to get out of my bed or chair and move around.

Willing and able to comply with the requirements of the protocol

Exclusion Criteria

Women who are breast feeding or plan to breast feed within the period of study participation

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

I am not pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a total of 7 injections of PepCan or placebo over a 24-month period

24 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

Treatment Details

Interventions

• PepCan

Trial Overview The trial is testing PepCan's safety and effectiveness against a placebo in preventing cancer recurrence. Participants will receive seven injections over two years. The study also looks at immune response and gut microbiome changes.

Participant Groups

Group I: PepCan Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+