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Head and Neck CancerPhase 2NCT02002182

ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer

A Phase 2 study testing ADXS11-001 (ADXS-HPV) in people with Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Andrew Sikora at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ADXS11-001 (ADXS-HPV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
Dec 2013to 1 Aug 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has newly-diagnosed, biopsy proven squamous cell carcinoma of Stage I-IV (T1-3, N0-2b) of the oropharynx.
  • The patient's tumor is HPV positive by PCR or ISH assay of tumor biopsy.
  • The patient is able/eligible to undergo treatment with transoral robotic surgery (TORS) with or without neck dissection and with or without adjuvant radiation therapy or chemoradiation.
  • The patient is able to understand and give informed consent.
  • The patient is at least 18 years old.
  • The patient's ECOG performance status is </= 2.

Who cannot join

  • The patient has had prior head and neck squamous cell carcinoma (HNSCC), with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  • The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas
  • If a cancer survivor, the disease free interval is less than 3 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
  • If a cancer survivor the patient received prior systemic chemotherapy or radiotherapy
  • If prior standard-of-care pre-treatment biopsy is inadequate for analysis by immunohistochemistry, and the patient is unwilling to undergo an additional biopsy procedure.
  • The patient is a prisoner.
Show all 18Show fewer
  • The patient has a psychiatric illness or developmental delay which would interfere with understanding of the study and provision of informed consent.
  • The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC.
  • The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.
  • Patient is allergic to naproxen or Ibuprofen.
  • The patient has a history of liver disease.
  • The patient has a contraindication (e.g. sensitivity/allergy) to both trimethoprim/sulfamethoxazole and ampicillin.
  • The patient has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants and venous access devices (e.g. Port-a-Cath or Mediport) are permitted.
  • Patients who are receiving or may receive future treatment with PI3K or TNFα inhibitors.
  • Patients who have undergone a major surgery, including surgery for a new artificial implant and/or device, within 6 weeks prior to the initiation of ADXS11-001 treatment. Sponsor must be consulted prior to enrolling subjects on the study who recently had a major surgery or have new artificial implant, and/or devices.
  • Patients who have a history of listeriosis or prior ADXS11-001 therapy.
  • Patients with a known allergy to any component of the study treatment formulations.
  • Pregnancy. The effects of this vaccine on the developing human fetus are unknown. For this reason women of child-bearing potential and men must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation, Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Window of Opportunity Trial of Neoadjuvant ADXS 11-001 Vaccination Prior to Robot -Assisted Resection of HPV-Positive Oropharyngeal Squamous Cell Carcinoma

Some cancers may be related to an infection with a virus, such as the Human Papilloma Virus (HPV). HPV related Oropharyngeal cancer (HPVOPC) accounts for 80% of oropharynx cancer cases in the United States. HPVOPC has better prognosis than patients with HPV negative oropharynx cancer. In many hospitals, the standard of care treatment for oropharyngeal cancer is surgery and/or radiotherapy with or without chemotherapy. While chances of survival for most patients with HPVOPC is very good, current treatments are associated with short- and long-term side effects which can be severe. In pre-clinical research using animal models of cancer, vaccination targeting the HPV virus has been found to cause tumor regression. Thus, approaches which target the unique characteristics of HPV-infected cancer cells, such as therapeutic vaccination, are attractive strategies for potentially reducing radiotherapy and chemo radiotherapy regimens (and thus decreasing toxicity) and enhancing long-term disease control.

The purpose of this study is to see if an experimental vaccine, ADXS11-001, is effective in stimulating the body's defense system against HPV-positive oropharyngeal squamous cell carcinoma before transoral (through the mouth) surgery. The experimental product ADXS11-001 uses a live strain of the Listeria monocytogenes (Lm) bacteria that has been genetically modified such that the risk of getting an infection is significantly reduced. Several research studies have already been conducted with ADXS11-001 in men and women with cancer. So far, approximately 722 doses of ADXS11-001 have been given to 290 patients with HPV associated cancers.

Read the detailed description

This is an investigator-initiated prospective clinical study of patients with stage I-IV squamous cell carcinoma of the oropharynx (OPSCC) who are to undergo ablative transoral robotic surgery (TORS).

There is a vaccination group and a control group in this study.

Subjects in the control group will not receive the vaccination and will only be followed after TORS surgery for additional research blood tests to measure how their immune system is working.

Subjects in the vaccination group will receive two vaccinations prior to surgery. The first dose will be about 33 days before surgery, and the second will be about 14 days before surgery.

Participation in this study will also include allowing the research team to take several blood samples from the subject at various times before, during, and after treatment for his/her cancer.

Vaccination subjects will be monitored closely after treatment and includes 6 months of oral antibiotics.

Being tested
ADXS11-001 (ADXS-HPV)
Keywords
HPV, oropharynx, squamous cell carcinoma, head and neck cancer, transoral robotic surgery
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADXS11-001 (ADXS-HPV)Biological

    Also called ADXS11-001, ADXS-HPV

    ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.

Study groups in NCT02002182
Study groupRoleWhat they receive
Treatment-Vaccine GroupExperimentalTwo 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.
Receives: Biological: ADXS11-001 (ADXS-HPV)
Control GroupNo interventionObservational control group treated with standard of care therapy only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HPV-Specific T Cell Response Rate

    Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to time of surgery.

    Measured: At time of surgery

  2. Number of Participants With Any Grade 3 or 4 Toxicity

    Degree of toxicity assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

    Measured: Assessed up to 30 Days after surgery

Secondary outcomes (1)

  1. HPV-Specific T Cell Response Rate

    Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to 3 months after surgery.

    Measured: Assessed up to 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completion1 Jul 2018
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02002182
Sponsor's protocol ID
H-36001 GCO 13-1411
Status last verified
Sep 2022
First submitted
29 Nov 2013
Last updated
22 Sep 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADXS11-001 (ADXS-HPV) in people with Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, run by Andrew Sikora at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HPV-Specific T Cell Response Rate (time frame: At time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02002182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.

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