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Cancer Vaccine

ADXS11-001 (ADXS-HPV) for Head and Neck Cancers

Phase 2
Waitlist Available
Led By Brett Miles, MD
Research Sponsored by Andrew Sikora
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 30 days after surgery
Awards & highlights

Study Summary

This trial is testing an experimental vaccine to see if it can help treat a cancer caused by HPV. The vaccine uses a live but weakened strain of bacteria, and so far it's been given to 290 patients with HPV-related cancers with no significant side effects.

Eligible Conditions
  • Head and Neck Cancers
  • Squamous Cell Carcinoma
  • Oropharyngeal Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 30 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 30 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Any Grade 3 or 4 Toxicity
Secondary outcome measures
HPV-Specific T Cell Response Rate

Side effects data

From 2019 Phase 2 trial • 15 Patients • NCT02002182
50%
Pain
33%
Dry mouth
33%
Vomiting
33%
Constipation
33%
Nausea
33%
Hoarseness
17%
tooth decay
17%
Depression
17%
Pain in right side of neck
17%
Mouth pain
17%
pressure in the right neck
17%
Fatigue
17%
Pain in neck
17%
lymphedema
17%
Jaw pain
17%
Neck Mass
17%
Difficulty with swallowing solid food
17%
Ear pain
17%
Mild odynophagia
17%
Left Ear Pain
17%
Dysphagia
17%
Heartburn
17%
Mild throat pain
17%
Tinnitus
17%
Vomitting
17%
constipation
17%
tongue ulcer
17%
Dry Mouth
17%
Decreased taste
17%
Dysarthria
17%
Loss of taste
17%
dysgeusia
17%
radiation associated dermatitis
17%
tender left arm lump
17%
Pain in right shoulder
17%
Right Neck Pain
17%
dry saliva
17%
mucositis
17%
Diarrhea
17%
Pain (in neck)
17%
Pain (in throat)
17%
Xerostomia
17%
left buccal mucosa lump
17%
pain in shoulder
17%
Intermittent neck stiffness
17%
Trismus
17%
Voice Change
17%
voice changes
17%
left lump posterior pharyngeal region
17%
Tonsillar Pain
17%
Numbness right Ear,Neck and back of head
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Treatment-Vaccine Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment-Vaccine GroupExperimental Treatment1 Intervention
Two vaccinations with ADXS11-001 (ADXS-HPV) will be given at a dose of 1x10^9 cfu intravenously. The drug will be given as a 500ml infusion over 60 minutes.
Group II: Control GroupActive Control1 Intervention
Observational control group treated with standard of care therapy only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axalimogene filolisbac
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Andrew SikoraLead Sponsor
Advaxis, Inc.Industry Sponsor
12 Previous Clinical Trials
532 Total Patients Enrolled
Andrew G Sikora, MD PhDStudy ChairBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer
Andrew Sikora 2013. "ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02002182.
~1 spots leftby Apr 2025
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