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Cancer Vaccine

PepCan for Head and Neck Cancers

University of Arkansas for Medical Sciences, Little Rock, AR
PepCan +1 morePhase 1 & 2Waitlist AvailableLed by Omar T Atiq, MDResearch Sponsored by University of Arkansas

Study 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.

Eligible Conditions
  • Head and Neck Cancer

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

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

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Diarrhea
14%
Upper respiratory tract infection
14%
Decreased appetite
10%
Injection site erythema
9%
Irritability postvaccinal
9%
Nasopharyngitis
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Injection site swelling
7%
Fatigue
7%
Myalgia
7%
Hypersomnia
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

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 site

Who is running the clinical trial?

University of ArkansasLead Sponsor
471 Previous Clinical Trials
147,734 Total Patients Enrolled
Omar T Atiq, MDPrincipal Investigator
University 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently searching for participants?

"Affirmative, the details available on clinicaltrials.gov indicate that this study is currently recruiting individuals for participation. The trial was first advertised in November 2019 and last revised October 2022. This experiment requires 20 test subjects from a single medical center to take part."

Answered by AI

Could you provide the aggregate figure for participants enrolled in this clinical trial?

"Affirmative. The information on clinicaltrials.gov pronounces that recruitment for this experiment is in progress. Initially posted on November 13th 2019, the trial was last updated October 18th 2022 and aims to recruit 20 participants from a single site."

Answered by AI

Am I eligible to join this investigation?

"This trial is seeking 20 applicants with head malignancies, ranging between 18 and 100 years of age. Essential eligibility criteria include a respiratory rate no lower than 12 nor higher than 25 breaths per minute, an ECOG performance status between 0-2, a heart rate that oscillates between 50 to 100 beats per minute, in addition to being either male or female aged over 18 years old."

Answered by AI

Are adolescents accepted in this investigation?

"The parameters for participation in this research trial require that individuals are aged between 18 and 100 years old."

Answered by AI

Could you please elucidate on any other investigations that have been done concerning PepCan?

"Presently, 3 clinical trials related to PepCan are ongoing. Not one of these is in its third phase; however, there are three medical centres operating studies for this treatment - all based in Little Rock, Arkansas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients
2019. "A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03821272.
~8 spots leftby Dec 2025
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