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PepCan for Cervical Neoplasia

Phase 2
Waitlist Available
Led By Mayumi N Nakagawa, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months from time of last vaccination
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new vaccine called PepCan and a substance called Candin® on women with specific cervical lesions. The goal is to see if these treatments can help the immune system fight off HPV infections and reduce or eliminate the lesions.

Eligible Conditions
  • Cervical Intraepithelial Neoplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months from time of last vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months from time of last vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Subjects With Complete Response With the Intention-to-treat (ITT) Analysis
Number of Subjects With Complete Response With the Per-protocol Analysis
Number of Subjects With Complete and Partial Responses With the ITT Analysis
+1 more
Secondary study objectives
Safety Assessed by Injection-related Adverse Events (AEs)

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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PepCanExperimental Treatment1 Intervention
Four injections (one every 3 weeks) of PepCan
Group II: CandinActive Control1 Intervention
Four injections (one every 3 weeks) of Candin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PepCan
2015
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
495 Previous Clinical Trials
150,289 Total Patients Enrolled
Mayumi N Nakagawa, MD, PhDPrincipal InvestigatorUniversity of Arkansas
~8 spots leftby Dec 2025
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