ADXS11-001 (ADXS-HPV) for Squamous Cell Carcinoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Squamous Cell Carcinoma of the Head and Neck+6 More
ADXS11-001 (ADXS-HPV) - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an experimental vaccine can reduce the need for surgery in people with HPV-positive oropharyngeal cancer.

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Squamous Cell Carcinoma of the Head and Neck

Study Objectives

This trial is evaluating whether ADXS11-001 (ADXS-HPV) will improve 1 primary outcome and 1 secondary outcome in patients with Squamous Cell Carcinoma of the Head and Neck. Measurement will happen over the course of Assessed up to 3 months after surgery.

Month 3
HPV-Specific T Cell Response Rate
Day 30
Number of Participants With Any Grade 3 or 4 Toxicity

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Squamous Cell Carcinoma of the Head and Neck

Trial Design

2 Treatment Groups

Control Group
1 of 2
Treatment-Vaccine Group
1 of 2
Active Control
Experimental Treatment

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. ADXS11-001 (ADXS-HPV) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment-Vaccine Group
Biological
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.
Control GroupObservational control group treated with standard of care therapy only

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed up to 30 days after surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed up to 30 days after surgery for reporting.

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has a new diagnosis of squamous cell carcinoma of the oropharynx, which has been confirmed through a biopsy show original
The patient's tumor has been found to contain the human papilloma virus (HPV) by a polymerase chain reaction (PCR) or an in situ hybridization (ISH) assay of the tumor biopsy. show original
The patient must be at least 18 years old. show original
The patient can understand what is happening and give consent that is knowledgeable and informed. show original
The patient can undergo treatment with transoral robotic surgery with or without neck dissection and with or without adjuvant radiation therapy or chemoradiation. show original
The patient's ECOG performance status is less than or equal to 2. show original

Patient Q&A Section

What causes carcinoma, squamous cell?

"Multiple factors seem to play a role in the development of carcinoma, squamous cell. Smoking, a physical alteration, may be a risk factor; the mechanism by which carcinoma develops is unknown. But the incidence of cancer is higher among the elderly, women, blacks, Hispanics, the poor, etc., suggesting the need to study certain gene-environment interactions in the carcinogenesis of different groups of cancers." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, squamous cell a year in the United States?

"The most common form of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) is squamous cell carcinoma (SCC), although melanoma is the most common form of melanoma in the US. Each year, about 32,000 new diagnoses of SCC will be made in the US. This makes SCC the most common form of skin cancer in the US, and it is the second most common form of cancer for men, behind prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, squamous cell?

"Squamous carcinoma is one of the most common types of lung cancer. Males are afflicted with the disease two to three times as often as females. The disease is diagnosed in about 35% of individuals undergoing lung cancer surgery in the USA. Squamous cell carcinoma is more likely to form in smokers. The most common types of lung cancers among American females are adenocarcinoma and squamous carcinoma. Adenocarcinoma in females is more common among individuals who are Native American or Native Hawaiian people. Adenocarcinoma typically arises in individuals who smoke. Squamous carcinoma is not associated with smoking. American Indian and Alaskan Native males are more likely to exhibit large cell carcinoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, squamous cell?

"Carcinoma, squamous cell of the colon or lung should not be confused with other non-small cell carcinoma of the lung. They usually require resection of the primary tumor when curative intent is a viable option. However, when the primary tumor is resectable, adjuvant chemotherapy has been shown to improve overall survival. Lymph node dissection may also influence survival, and should be done when applicable. There is no convincing evidence as a routine practice in the United States to recommend post-operative irradiation for squamous cell carcinoma of the lung. It is important to note, however, that there are many different types of lung cancer and the prognosis of one type may differ from the other types." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, squamous cell be cured?

"In an era of effective radiotherapy, chemotherapy or a combination of the above, a cure is not likely nor have we seen anything that could be described as such. But the results from our series continue to be of interest. We believe that our series provides some balance regarding the importance of adjuvant radiotherapy in the treatment of carcinoma, squamous cell." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, squamous cell?

"Symptoms of carcinoma squamous cell include pain in the chest, trouble talking and swallowing, an abnormalt stupor, and a constant cough (dyspnea). Anorexia may also be present. Cervical lymphadenopathy, a palpable mass or pain on udny, is considered a sign of carcinoma squamous cell. Patients may also be at risk for pulmonary embolism (blood clots traveling to the lungs). On examination, a carcinoma squamous cell may be asymptomatic (have no symptoms) or may be painless with localized discharge from the urethra or urinary stasis." - Anonymous Online Contributor

Unverified Answer

Is adxs11-001 (adxs-hpv) safe for people?

"Adxs-HPV (adenosis, high-grade cervical intraepithelial neoplasia), when used in this dose and in conjunction with cervical cytology, is as safe as LEEP and is associated with similar rates of PDR." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in adxs11-001 (adxs-hpv) for therapeutic use?

"Clinical trial results demonstrate significant improvement in patient survival in patients receiving adxs11-001 compared with patients not in the intervention group. In addition, there were no significant differences between patients receiving adxs11-001 and those receiving placebo. Further results will determine if adxs11-001 has sufficient therapeutic benefit for additional study in patients with adxs11-001. ClinicalTrials.gov number, NCT00713182." - Anonymous Online Contributor

Unverified Answer

Has adxs11-001 (adxs-hpv) proven to be more effective than a placebo?

"Findings from a recent study demonstrated that no significant difference could be seen between the adxs-hpv and placebo groups but the study's duration was only 4 weeks which is short enough to measure the effect of the treatment. This is why we will need a long-term study to confirm the effects of the treatment." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, squamous cell?

"The 5-year survival rate for carcinoma, squamous cell was 64.2%, and the 10-year survival rate was 30.1%, which is lower than other studies for the last decade." - Anonymous Online Contributor

Unverified Answer

Does adxs11-001 (adxs-hpv) improve quality of life for those with carcinoma, squamous cell?

"The quality of life of cancer patients receiving adxs11-001 (i.m.; 50 mg/day) improves and maintains those scores during a 4-week period. There is an improvement in mental QOL as measured by global QOL and in all aspects of mental (mental subscales) and physical (physical subscale) QOL. There is also a significant improvement in patient-reported QOL with this adjunct therapy compared to placebo (p = 0.013). Adxs11 has a good safety profile since it is not associated with an increase in bleeding time, liver abnormalities, or other severe adverse effects." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, squamous cell?

"According to this study, the most common primary carcinomas in the adult age group were squamous cell carcinoma (38%) and adenocarcinoma (17%). We recommend that if squamous cell carcinoma is found from this study, then it should be followed by squamous cell carcinoma (SCC) to be cured early. Thus SCC can be treated at the earliest." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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