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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02002182

Recruitment Status : Completed

First Posted : December 5, 2013

Results First Posted : July 2, 2020

Last Update Posted : September 22, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Advaxis, Inc.

Information provided by (Responsible Party):

Andrew Sikora, Baylor College of Medicine

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Head and Neck Cancer Squamous Cell Carcinoma of the Head and Neck HPV Positive Oropharyngeal Squamous Cell Carcinoma
Intervention	Biological: ADXS11-001 (ADXS-HPV)
Enrollment	15

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (A...	Observational control group treated...
Arm/Group Description	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. 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.	Observational control group treated with standard of care therapy only
Period Title: Overall Study
Started	9	6
Completed	4	5
Not Completed	5	1
Reason Not Completed
Withdraw from study	3	1
Health Reasons	1	0
Death	1	0

Baseline Characteristics

Arm/Group Title		Treatment-Vaccine Group	Control Group	Total
Arm/Group Description		Two vaccinations with ADXS11-001 (A...	Observational control group treated...	Total of all reporting groups
Arm/Group Description		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. 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.	Observational control group treated with standard of care therapy only	Total of all reporting groups
Overall Number of Baseline Participants		9	6	15
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	9 participants	6 participants	15 participants
		72 (51 to 91)	53 (49 to 62)	62 (49 to 91)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	6 participants	15 participants
	Female	2 22.2%	1 16.7%	3 20.0%
	Male	7 77.8%	5 83.3%	12 80.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	6 participants	15 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	7 77.8%	6 100.0%	13 86.7%
	Unknown or Not Reported	2 22.2%	0 0.0%	2 13.3%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	6 participants	15 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 11.1%	1 16.7%	2 13.3%
	White	6 66.7%	5 83.3%	11 73.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 22.2%	0 0.0%	2 13.3%

Outcome Measures

1.Primary Outcome


Title	HPV-Specific T Cell Response Rate
Description	Response rate defined as proportion of participants with a >2-fold ...
Description	Response rate defined as proportion of participants with a >2-fold increase in HPV-specific T cell response from baseline to time of surgery.
Time Frame	At time of surgery

Outcome Measure Data

Analysis Population Description

The analysis included participants who had HPV-specific T cell response measurement at time of surgery. T cell response data were not collected at time of surgery for the control group, which was an optional observational group.


Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description:	Two vaccinations with ADXS11-001 (A...	Observational control group treated...
Arm/Group Description:	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. 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.	Observational control group treated with standard of care therapy only
Overall Number of Participants Analyzed	9	0
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: proportion of participants
	0.333 (0.075 to 0.701)

2.Primary Outcome


Title	Number of Participants With Any Grade 3 or 4 Toxicity
Description	Degree of toxicity assessed according to NCI Common Terminology Criter...
Description	Degree of toxicity assessed according to NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Time Frame	Assessed up to 30 Days after surgery

Outcome Measure Data

Analysis Population Description

All participants were included in the analysis.


Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description:	Two vaccinations with ADXS11-001 (A...	Observational control group treated...
Arm/Group Description:	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. 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.	Observational control group treated with standard of care therapy only
Overall Number of Participants Analyzed	9	6
Measure Type: Count of Participants Unit of Measure: Participants
	5 55.6%	1 16.7%

3.Secondary Outcome


Title	HPV-Specific T Cell Response Rate
Description	Response rate defined as proportion of participants with a >2-fold ...
Description	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.
Time Frame	Assessed up to 3 months after surgery

Outcome Measure Data

Analysis Population Description

The analysis included participants who had at least one HPV-specific T cell response measurement post surgery.


Arm/Group Title	Treatment-Vaccine Group	Control Group
Arm/Group Description:	Two vaccinations with ADXS11-001 (A...	Observational control group treated...
Arm/Group Description:	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. 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.	Observational control group treated with standard of care therapy only
Overall Number of Participants Analyzed	8	4
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: proportion of participants
	0.625 (0.245 to 0.915)	0.75 (0.194 to 0.994)

Adverse Events

Time Frame	Up to 3 year post treatment for the vaccinated group or post surgery for the control group.
Adverse Event Reporting Description	Adverse events (AE) were collected starting on the first day of vaccine administration and evaluated for severity and relationship to treatment for 30 days post treatment and for 3 year safety observation period. AE of grade 3 or higher were designated severe adverse events (SAE).

Arm/Group Title	Treatment-Vaccine Group		Control Group
Arm/Group Description	Two vaccinations with ADXS11-001 (A...		Observational control group treated...
Arm/Group Description	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. 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.		Observational control group treated with standard of care therapy only
All-Cause Mortality
	Treatment-Vaccine Group		Control Group
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/9 (11.11%)		0/6 (0.00%)
Serious Adverse Events Serious Adverse Events
	Treatment-Vaccine Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/9 (55.56%)		1/6 (16.67%)
Cardiac disorders
Hypertension ^† 1	1/9 (11.11%)	2	0/6 (0.00%)	0
Gastrointestinal disorders
Dysphagia ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Vomitting ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
General disorders
Failure to thrive ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Mouth pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Pain in throat and left ear when swollowing ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Skin and subcutaneous tissue disorders
Dermatitis ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
mucositis ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
1 Term from vocabulary, CTCAE V4 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment-Vaccine Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100.00%)		6/6 (100.00%)
Blood and lymphatic system disorders
Decreased WBCs ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Leukopenia ^† 1	1/9 (11.11%)	2	0/6 (0.00%)	0
Localized edema ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Monocytosis ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Neutrophil count decreased ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
White blood cell decreased ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
lymphedema ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Cardiac disorders
Hypertension ^† 1	2/9 (22.22%)	2	0/6 (0.00%)	0
Hypotension ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Tachycardia ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Tachycardia (HR112) ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Tachychardia ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Ear and labyrinth disorders
Tinnitus ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Endocrine disorders
Face Flushing ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Flushed Face ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Flushing ^† 1	2/9 (22.22%)	2	0/6 (0.00%)	0
Flushing (face+neck) ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Sweating ^† 1	2/9 (22.22%)	2	0/6 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Constipation ^† 1	6/9 (66.67%)	7	2/6 (33.33%)	2
Diarrhea ^† 1	2/9 (22.22%)	2	1/6 (16.67%)	1
Difficulty with swallowing solid food ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Dysphagia ^† 1	7/9 (77.78%)	12	1/6 (16.67%)	1
Heartburn ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Intermittent diarrhea after taking Bactrim ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Nausea ^† 1	4/9 (44.44%)	7	2/6 (33.33%)	2
Upset Stomach ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Vomiting ^† 1	1/9 (11.11%)	1	2/6 (33.33%)	2
Vomitting ^† 1	1/9 (11.11%)	1	1/6 (16.67%)	1
constipation ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
tongue ulcer ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
General disorders
Anorexia ^† 1	3/9 (33.33%)	3	0/6 (0.00%)	0
Body ache ^† 1	3/9 (33.33%)	3	0/6 (0.00%)	0
Chill ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Chills ^† 1	7/9 (77.78%)	10	0/6 (0.00%)	0
Dry Mouth ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Dry mouth ^† 1	1/9 (11.11%)	1	2/6 (33.33%)	2
Ear pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Fatigue ^† 1	5/9 (55.56%)	8	1/6 (16.67%)	1
Fever ^† 1	5/9 (55.56%)	7	0/6 (0.00%)	0
Intermittent throat pain when swallowing ^† 1	1/9 (11.11%)	2	0/6 (0.00%)	0
Jaw pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Left Ear Pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Mild discomfort in the throat on the left side ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Mild odynophagia ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Mild throat pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Neck Mass ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Occasional fatigue ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Occasional pain in throat ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Pain ^† 1	1/9 (11.11%)	1	3/6 (50.00%)	3
Pain (in neck) ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Pain (in throat) ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Pain in left jaw ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Pain in legs ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Pain in neck ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Pain in right ear ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Pain in right ear,nec ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Pain in right shoulder ^† 1	1/9 (11.11%)	1	1/6 (16.67%)	2
Pain in right side of neck ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Right Neck Pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Right Shoulder Pain ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Shivering ^† 1	1/9 (11.11%)	2	0/6 (0.00%)	0
Slight sore throat ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Throat pain ^† 1	2/9 (22.22%)	2	0/6 (0.00%)	0
Tonsillar Pain ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Weakening ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Xerostomia ^† 1	1/9 (11.11%)	1	1/6 (16.67%)	1
dry saliva ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
left buccal mucosa lump ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
minor discomfort when swallowing ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
pain in right neck ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
pain in right neck, shoulder ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
pain in shoulder ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
pain in throat ^† 1	3/9 (33.33%)	5	0/6 (0.00%)	0
pressure in the right neck ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
slight tightness on outside of left neck at surgical site when out in the cold only ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
tooth decay ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Metabolism and nutrition disorders
Gout ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Intermittent neck stiffness ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Myalgia ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Trismus ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
cramping in feet ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Nervous system disorders
Decreased taste ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Dysarthria ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Dysgeusia ^† 1	2/9 (22.22%)	2	0/6 (0.00%)	0
Headache ^† 1	3/9 (33.33%)	5	0/6 (0.00%)	0
Headache Intermittent ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Loss of taste ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	2
Memory loss and cognitive decline ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Numbness right Ear,Neck and back of head ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
dysgeusia ^† 1	1/9 (11.11%)	1	1/6 (16.67%)	1
headache ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Psychiatric disorders
Anxiety ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Depression ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Euphoria ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Blood tinged sputum ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Hoarseness ^† 1	1/9 (11.11%)	1	2/6 (33.33%)	2
Voice Change ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
voice changes ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
Skin and subcutaneous tissue disorders
Mucositis ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
Rash ^† 1	2/9 (22.22%)	2	0/6 (0.00%)	0
Rash (chest, back of neck) ^† 1	1/9 (11.11%)	1	0/6 (0.00%)	0
left lump posterior pharyngeal region ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
radiation associated dermatitis ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
tender left arm lump ^† 1	0/9 (0.00%)	0	1/6 (16.67%)	1
1 Term from vocabulary, CTCAE V4 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Andrew Sikora
Organization:	Baylor College of Medicine
Phone:	7137983909
EMail:	Andrew.Sikora@bcm.edu

Layout table for additonal information

Responsible Party:	Andrew Sikora, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT02002182
Other Study ID Numbers:	H-36001 GCO 13-1411
First Submitted:	November 29, 2013
First Posted:	December 5, 2013
Results First Submitted:	June 9, 2020
Results First Posted:	July 2, 2020
Last Update Posted:	September 22, 2022

To Top