NCT02002182

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

Completed Phase 2 Results posted Last updated 9 September 2022

What this trial tests

Phase 2 trial testing ADXS11-001 (ADXS-HPV) in Head and Neck Cancer in 15 participants. Completed in 1 August 2019.

Timeline

1 December 2013

Primary endpoint
1 July 2018

1 August 2019

Quick facts

Lead sponsor	Andrew Sikora
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 December 2013
Primary completion	1 July 2018
Estimated completion	1 August 2019
Sites	2 locations across United States

Drugs / interventions tested

• ADXS11-001 (ADXS-HPV) — full drug profile →

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →
• HPV Positive Oropharyngeal Squamous Cell Carcinoma — all drugs for HPV Positive Oropharyngeal Squamous Cell Carcinoma →

Sponsor

Andrew Sikora — full company profile →

Who can join

18 and older, any sex, with Head and Neck Cancer or Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• HPV-Specific T Cell Response Rate
  Time frame: At time of surgery
  Response rate defined as proportion of participants with a \>2-fold increase in HPV-specific T cell response from baseline to time of surgery.
• Number of Participants With Any Grade 3 or 4 Toxicity
  Time frame: Assessed up to 30 Days after surgery
  Degree of toxicity assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC).
   Cohen EEW, Bell RB, Bifulco CB, Burtness B, et al · · 2019 · cited 528× · PMID 31307547 · DOI 10.1186/s40425-019-0662-5
2. Immunology and Immunotherapy of Head and Neck Cancer.
   Ferris RL. · · 2015 · cited 515× · PMID 26351330 · DOI 10.1200/jco.2015.61.1509
3. Microbiota in Tumors: From Understanding to Application.
   Xie Y, Xie F, Zhou X, Zhang L, et al · · 2022 · cited 156× · PMID 35603968 · DOI 10.1002/advs.202200470
4. Therapeutic vaccines for high-risk HPV-associated diseases.
   Chabeda A, Yanez RJR, Lamprecht R, Meyers AE, et al · · 2018 · cited 148× · PMID 29277575 · DOI 10.1016/j.pvr.2017.12.006
5. Perspectives for therapeutic HPV vaccine development.
   Yang A, Farmer E, Wu TC, Hung CF. · · 2016 · cited 143× · PMID 27809842 · DOI 10.1186/s12929-016-0293-9
6. Tumor Immunity and Immunotherapy for HPV-Related Cancers.
   Shamseddine AA, Burman B, Lee NY, Zamarin D, et al · · 2021 · cited 140× · PMID 33990345 · DOI 10.1158/2159-8290.cd-20-1760
7. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
8. Current state in the development of candidate therapeutic HPV vaccines.
   Yang A, Jeang J, Cheng K, Cheng T, et al · · 2016 · cited 92× · PMID 26901118 · DOI 10.1586/14760584.2016.1157477