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Cancer Vaccine

PepCan for Head and Neck Cancer

Phase 1 & 2
Waitlist Available
Led By Omar T Atiq, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
Must not have
Positive urine pregnancy test for women of childbearing potential
History of recurrence of squamous cell carcinoma of the head and neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial will test if seven injections of PepCan over two years can help prevent HPV-related head and neck cancers from coming back. They will also look at side effects and changes in the gut microbiome.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of PepCan aren't listed here, common reactions to new treatments may include local injection site reactions, flu-like symptoms such as fever or fatigue, allergic responses, or gastrointestinal disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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My tests show no signs of cancer.
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I have completed treatment for head or neck cancer within the last 4 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant.
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My cancer in the head or neck area has come back.
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I have previously received PepCan treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events - evaluate safety of a 7-injection regimen of PepCan.
Secondary study objectives
Cancer recurrence rate - efficacy of a 7-injection regimen of PepCan

Side effects data

From 2022 Phase 2 trial • 81 Patients • NCT02481414
90%
Injection Site Reaction
29%
Headache
29%
Nausea
24%
Hypokalemia
21%
Hypoalbuminemia
21%
Myalgia
17%
Aspartate Aminotransferase Increased
17%
Anemia
17%
Fatigue
14%
Skin and Subcutaneous Tissue Disorders - Other, Specify
12%
Dizziness
12%
Vaginal Infection
12%
Alanine Aminotransferase Increased
10%
Gastrointestinal Disorders - Other, Specify
10%
Fever
10%
Pain
10%
Flu-like Symptoms
10%
Urinary Tract Infection
10%
Infections and Infestations - Others, Specify
10%
Hypocalcemia
7%
Vaginal Hemorrhage
7%
Hypothyroidism
7%
Creatinine Increased
7%
Back Pain
7%
Unintended Pregnancy
7%
Anxiety
5%
Abdominal Pain
5%
Diarrhea
5%
Bruising
5%
Hemoglobin Increased
5%
White Blood Cell Decreased
5%
Investigations - Other, Specify
5%
Bone Pain
5%
Depression
5%
Dyspareunia
5%
Irregular Menstruation
5%
Reproductive System and Breast Disorders - Other, Specify
5%
Allergic Rhinitis
5%
Dyspnea
5%
Sore Throat
2%
Platelet Count Decreased
2%
Urinary Urgency
2%
Non-Cardiac Chest Pain
2%
Palpitations
2%
Appendicitis
2%
Fetal Death
2%
Sinus Bradycardia
2%
Colitis
2%
Constipation
2%
Bloating
2%
Chest Pain - Cardiac
2%
Localized Edema
2%
Eye Disorders 0 Other, Specify
2%
Vomitting
2%
Stomach Pain
2%
Upper Respiratory Infection
2%
Alkaline Phosphatase Increased
2%
Gastrointestinal Pain
2%
Edema Limbs
2%
Blood Bilirubin Increased
2%
Dehydration
2%
Obesity
2%
Hyperglycemia
2%
Hyponatremia
2%
Muscle Weakness Upper Limb
2%
Osteoporosis
2%
Pain in Extremity
2%
Paresthesia
2%
Somnolence
2%
Hemturia
2%
Breast Pain
2%
Vaginal Pain
2%
Cough
2%
Nasal Congestion
2%
Alopecia
2%
Erythema Multiforme
2%
Rash Acneiform
2%
Skin Ulceration
2%
Hot Flashes
2%
Hypertension
2%
Hypotension
2%
Skin Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Candin
PepCan

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PepCanExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Candida albicans
FDA approved

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
496 Previous Clinical Trials
150,643 Total Patients Enrolled
Omar T Atiq, MDPrincipal InvestigatorUniversity of Arkansas

Media Library

PepCan (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03821272 — Phase 1 & 2
Head and Neck Cancers Research Study Groups: PepCan, Placebo
Head and Neck Cancers Clinical Trial 2023: PepCan Highlights & Side Effects. Trial Name: NCT03821272 — Phase 1 & 2
PepCan (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03821272 — Phase 1 & 2
~1 spots leftby Apr 2025
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