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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test PepCan, a treatment that might help prevent the return of head and neck cancers, particularly those linked to HPV. Participants will receive either PepCan or a placebo through seven injections over 24 months. The researchers aim to determine PepCan's safety and effectiveness, focusing on reducing cancer recurrence and observing changes in the immune system and gut health. This trial may suit individuals who have recently completed treatment for head and neck cancer and currently show no signs of the disease. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that PepCan is likely to be safe for humans?

Research shows that PepCan is generally well-tolerated. In earlier studies, patients received several injections and reported few serious side effects, suggesting the treatment is safe. However, as with any clinical trial, risks can exist. Researchers design these trials to monitor safety and check for any negative effects. They closely watch participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for head and neck cancer, which often involve surgery, radiation, and chemotherapy, PepCan is unique because it harnesses the power of the immune system. PepCan is a therapeutic vaccine designed to stimulate the body's immune response to target and destroy cancer cells. Researchers are excited about this approach because it offers a potentially less invasive and more targeted alternative, aiming to enhance the body's natural defenses against cancer while minimizing the side effects typically associated with traditional cancer treatments.

What evidence suggests that PepCan might be an effective treatment for head and neck cancer?

Research has shown that PepCan, which participants in this trial may receive, may help treat head and neck cancer, especially when linked to HPV (human papillomavirus). One study found PepCan to be 45.8% effective in preventing cancer recurrence, helping nearly half of the participants avoid a return of their cancer. Additionally, PepCan strengthens the immune system's ability to fight these cancers. These results suggest that PepCan could be a good option for people recovering from head and neck cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Omar T Atiq, MD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03821272

NCT03821272 | A Phase I/II Clinical Trial of PepCan in ... 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

2. withpower.com withpower.com/trial/phase-2-head-and-neck-neoplasms-10-2019-53f04

PepCan for Head and Neck Cancer · Info for Participants 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10056222/

Therapeutic Vaccination in Head and Neck Squamous Cell ... They demonstrated the safety and therapeutic efficacy of PepCan against ... Head and Neck Cancer Enhance the Efficacy of Checkpoint Inhibitor. Front ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/72/NCT03821272/Prot_SAP_001.pdf

PepCan in Head and Neck Cancer Patients IRB 217672 ... Secondary Outcome Measure: Efficacy of 7 dose regimen by clinically observing cancer recurrence. Tertiary Outcome: Immunological responses ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.01.18.25320725v1.full-text

A Randomized Double-Blind Phase 2 Clinical Trial ... Likewise, with the per-protocol analysis, PepCan (n=24) showed 45.8% efficacy (95% CI, 25.6 to 67.2; p=0.08) and Candida (n=29) showed 62.1% ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT03821272

A Phase I/II Clinical Trial of PepCan in Head and Neck ... To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms. 2 years. Copyright © LARVOL 2025.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10670496/

Head and Neck Squamous Cell Carcinoma Vaccine A phase 1 trial (UMIN000000976) showed the safety and advantageous therapeutic potential of survivin-2B peptide vaccination in HLA-A*2402 ...