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Trial record 2 of 10 for:    adxs11-001

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

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ClinicalTrials.gov Identifier: NCT02002182
Recruitment Status : Active, not recruiting
First Posted : December 5, 2013
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2021
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment-Vaccine Group Control Group
Hide 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
Arm/Group Title Treatment-Vaccine Group Control Group Total
Hide 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
Hide 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%
1.Primary Outcome
Title HPV-Specific T Cell Response Rate
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in the analysis.
Arm/Group Title Treatment-Vaccine Group Control Group
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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%)    
Hide 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
Hide 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
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: July 2, 2021