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

NCT02002182 | Completed Phase 2 Results DMC

• 1 other identifier: H-36001 GCO 13-1411
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Head and Neck Cancer; Squamous Cell Carcinoma of the Head and Neck; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

HPV; oropharynx; squamous cell carcinoma; head and neck cancer; transoral robotic surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  At time of surgery

• 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.

  Assessed up to 30 Days after surgery

Secondary Outcomes (1)

• HPV-Specific T Cell Response Rate

  Assessed up to 3 months after surgery

Study Arms (2)

Treatment-Vaccine Group

EXPERIMENTAL

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.

Biological: ADXS11-001 (ADXS-HPV)

Control Group

NO INTERVENTION

Observational control group treated with standard of care therapy only

Interventions

ADXS11-001 (ADXS-HPV) BIOLOGICAL

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

Also known as: ADXS11-001, ADXS-HPV

Treatment-Vaccine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Andrew Sikora: lead
• Advaxis, Inc.: collaborator

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Results Point of Contact

• Title: Dr. Andrew Sikora
• Organization: Baylor College of Medicine

Andrew.Sikora@bcm.edu

7137983909

Study Officials

• Andrew G Sikora, MD PhD

  Baylor College of Medicine

  STUDY CHAIR

• Brett Miles, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 22, 2022
• Results First Posted: July 2, 2020

Record last verified: 2022-09

Locations

US (2)