Trial Outcomes & Findings for Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (NCT NCT02163057)
NCT ID: NCT02163057
Last Updated: 2021-01-22
Results Overview
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. TEAE is defined as any AE with onset after the administration of study medication through the end-of-study follow-up, or any event that was present at baseline but worsened in intensity or was subsequently considered treatment-related by the Investigator through the end of the study. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life-threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful or requires inpatient hospitalization or prolongation of existing hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 6 months post last dose
Results posted on
2021-01-22
Participant Flow
Participants with a diagnosis of HPV associated head and neck squamous cell carcinoma were enrolled in the study between 13th August 2014 to 23rd January 2017.
Participant milestones
| Measure |
Cohort 1: Surgery Cohort
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
16
|
|
Overall Study
COMPLETED
|
3
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Cohort 1: Surgery Cohort
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Overall Study
Participant Refusal to Continue
|
2
|
2
|
|
Overall Study
Participant Significant Noncompliance
|
0
|
1
|
|
Overall Study
Progression of Disease
|
1
|
2
|
Baseline Characteristics
Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Cohort 1: Surgery Cohort
n=6 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=16 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 4.26 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months post last dosePopulation: Safety population included all participants who received at least one dose of study treatment plus EP.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. TEAE is defined as any AE with onset after the administration of study medication through the end-of-study follow-up, or any event that was present at baseline but worsened in intensity or was subsequently considered treatment-related by the Investigator through the end of the study. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life-threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful or requires inpatient hospitalization or prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=6 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=16 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs)
At least 1 TEAE
|
6 Participants
|
15 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs)
At least 1 Treatment-emergent SAE
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months post last dosePopulation: Assigned Number of Doses (ANoD) population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.
Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=5 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=15 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 1st dose
|
3.6 log titer
Standard Deviation 4.53
|
0.4 log titer
Standard Deviation 1.18
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 2nd dose
|
2.2 log titer
Standard Deviation 2.61
|
0.0 log titer
Standard Deviation 0.00
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 3rd dose
|
2.6 log titer
Standard Deviation 2.39
|
1.2 log titer
Standard Deviation 2.33
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 4th dose
|
2.4 log titer
Standard Deviation 3.44
|
1.0 log titer
Standard Deviation 2.42
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, Week 2 post last dose
|
2.8 log titer
Standard Deviation 3.48
|
2.3 log titer
Standard Deviation 2.91
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 1st long term follow-up
|
1.3 log titer
Standard Deviation 2.51
|
1.0 log titer
Standard Deviation 2.42
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 2nd long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.2 log titer
Standard Deviation 2.63
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 3rd long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
0.8 log titer
Standard Deviation 2.40
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 4th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.4 log titer
Standard Deviation 3.39
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 5th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
0.0 log titer
Standard Deviation 0.00
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, 6th long term follow-up
|
—
|
3.1 log titer
Standard Deviation 4.32
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, initial surgery
|
1.0 log titer
Standard Deviation 2.24
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, follow-up Week 2 post-surgery
|
4.6 log titer
Standard Deviation 1.27
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, optional surgery
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, unscheduled visit
|
3.9 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-16 ELISA titer, end of study follow-up
|
0.0 log titer
Standard Deviation 0.00
|
0.0 log titer
Standard Deviation 0.00
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 1st dose
|
0.0 log titer
Standard Deviation 0.00
|
0.4 log titer
Standard Deviation 1.18
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 2nd dose
|
0.0 log titer
Standard Deviation 0.00
|
0.7 log titer
Standard Deviation 1.69
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 3rd dose
|
0.0 log titer
Standard Deviation 0.00
|
0.8 log titer
Standard Deviation 1.88
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 4th dose
|
1.0 log titer
Standard Deviation 2.24
|
1.2 log titer
Standard Deviation 2.12
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, Week 2 post last dose
|
0.0 log titer
Standard Deviation 0.00
|
3.0 log titer
Standard Deviation 3.25
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 1st long term follow-up
|
1.3 log titer
Standard Deviation 2.51
|
2.0 log titer
Standard Deviation 3.04
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 2nd long term follow-up
|
1.0 log titer
Standard Deviation 2.24
|
1.3 log titer
Standard Deviation 2.09
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 3rd long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.1 log titer
Standard Deviation 2.28
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 4th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.7 log titer
Standard Deviation 2.68
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 5th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.7 log titer
Standard Deviation 2.89
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, 6th long term follow-up
|
—
|
6.1 log titer
Standard Deviation 0.00
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, initial surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, follow-up Week 2 post-surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, optional surgery
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, unscheduled visit
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
HPV-18 ELISA titer, end of study follow-up
|
1.5 log titer
Standard Deviation 3.05
|
2.8 log titer
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Up to 6 months post last dosePopulation: ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.
Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=5 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=15 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, optional surgery
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16, 1st dose
|
0.0 log titer
Standard Deviation 0.00
|
0.4 log titer
Standard Deviation 1.18
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 2nd dose
|
0.0 log titer
Standard Deviation 0.00
|
0.5 log titer
Standard Deviation 1.69
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 3rd dose
|
1.2 log titer
Standard Deviation 2.73
|
2.1 log titer
Standard Deviation 2.85
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 4th dose
|
3.0 log titer
Standard Deviation 3.06
|
3.0 log titer
Standard Deviation 3.41
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, Week 2 post last dose
|
2.8 log titer
Standard Deviation 3.48
|
3.3 log titer
Standard Deviation 4.09
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 1st long term follow-up
|
2.5 log titer
Standard Deviation 3.03
|
2.8 log titer
Standard Deviation 3.63
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 2nd long term follow-up
|
0.8 log titer
Standard Deviation 1.75
|
1.6 log titer
Standard Deviation 3.28
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 3rd long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.5 log titer
Standard Deviation 3.24
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 4th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
0.8 log titer
Standard Deviation 2.05
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 5th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
3.1 log titer
Standard Deviation 5.43
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, 6th long term follow-up
|
—
|
4.2 log titer
Standard Deviation 5.87
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, initial surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, follow-up Week 2 post-surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, optional surgery
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, unscheduled visit
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-16 ELISA titer, end of study follow-up
|
0.0 log titer
Standard Deviation 0.00
|
1.3 log titer
Standard Deviation 2.45
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 1st dose
|
0.0 log titer
Standard Deviation 0.00
|
0.5 log titer
Standard Deviation 1.51
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 2nd dose
|
2.5 log titer
Standard Deviation 2.89
|
0.3 log titer
Standard Deviation 1.08
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 3rd dose
|
2.7 log titer
Standard Deviation 3.67
|
1.3 log titer
Standard Deviation 2.03
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 4th dose
|
4.5 log titer
Standard Deviation 4.17
|
3.0 log titer
Standard Deviation 3.21
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, Week 2 post last dose
|
8.0 log titer
Standard Deviation 1.65
|
4.2 log titer
Standard Deviation 2.83
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 1st long term follow-up
|
6.9 log titer
Standard Deviation 2.44
|
4.5 log titer
Standard Deviation 3.41
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 2nd long term follow-up
|
5.8 log titer
Standard Deviation 3.98
|
1.8 log titer
Standard Deviation 3.13
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 3rd long term follow-up
|
2.0 log titer
Standard Deviation 2.77
|
3.1 log titer
Standard Deviation 3.79
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 4th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
2.5 log titer
Standard Deviation 2.83
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 5th long term follow-up
|
0.0 log titer
Standard Deviation 0.00
|
5.5 log titer
Standard Deviation 4.80
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, 6th long term follow-up
|
—
|
8.3 log titer
Standard Deviation 0.00
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, initial surgery
|
0.0 log titer
Standard Deviation 0.00
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, surgery
|
2.4 log titer
Standard Deviation 4.70
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, follow-up Week 2 post-surgery
|
1.3 log titer
Standard Deviation 2.26
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, unscheduled visit
|
0.0 log titer
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
—
|
|
E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA
HPV-18 ELISA titer, end of study follow-up
|
4.4 log titer
Standard Deviation 5.29
|
4.6 log titer
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline up to 6 months post last dosePopulation: ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=5 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=15 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
Baseline
|
20.3 SFU/10^6 PBMC
Standard Deviation 22.65
|
11.7 SFU/10^6 PBMC
Standard Deviation 10.25
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 2nd dose
|
24.2 SFU/10^6 PBMC
Standard Deviation 34.56
|
96.9 SFU/10^6 PBMC
Standard Deviation 118.41
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 3rd dose
|
15.0 SFU/10^6 PBMC
Standard Deviation 17.54
|
158.9 SFU/10^6 PBMC
Standard Deviation 231.73
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 4th dose
|
50.3 SFU/10^6 PBMC
Standard Deviation 49.06
|
263.6 SFU/10^6 PBMC
Standard Deviation 597.80
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at Week 2 post last dose
|
68.3 SFU/10^6 PBMC
Standard Deviation 63.98
|
354.7 SFU/10^6 PBMC
Standard Deviation 632.29
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 1st long term follow-up
|
182.2 SFU/10^6 PBMC
Standard Deviation 211.31
|
128.8 SFU/10^6 PBMC
Standard Deviation 132.05
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 2nd long term follow-up
|
102.3 SFU/10^6 PBMC
Standard Deviation 140.03
|
151.1 SFU/10^6 PBMC
Standard Deviation 94.32
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 3rd long term follow-up
|
127.6 SFU/10^6 PBMC
Standard Deviation 3.46
|
113.2 SFU/10^6 PBMC
Standard Deviation 153.59
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 4th long term follow-up
|
41.4 SFU/10^6 PBMC
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
29.8 SFU/10^6 PBMC
Standard Deviation 28.11
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 5th long term follow-up
|
129.1 SFU/10^6 PBMC
Standard Deviation 19.87
|
0.0 SFU/10^6 PBMC
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at 6th long term follow-up
|
141.7 SFU/10^6 PBMC
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
11.7 SFU/10^6 PBMC
Standard Deviation NA
Standard deviation could not be calculated due to an insufficient number of participants.
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at follow-up Week 2 post-surgery
|
154.2 SFU/10^6 PBMC
Standard Deviation 168.50
|
—
|
|
Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot)
CFB at end of study follow-up
|
50.0 SFU/10^6 PBMC
Standard Deviation 42.75
|
70.5 SFU/10^6 PBMC
Standard Deviation 87.09
|
SECONDARY outcome
Timeframe: At baseline and Week 2 post last dosePopulation: ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.
A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=5 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=15 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry
CD8+CD137+GrzA+GrzB+Prf+, baseline
|
0.09 cells/million T-cells
Standard Deviation 0.124
|
0.02 cells/million T-cells
Standard Deviation 0.039
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry
CD8+CD137+GrzA+GrzB+Prf+,CFB Week 2 post last dose
|
0.16 cells/million T-cells
Standard Deviation 0.230
|
0.11 cells/million T-cells
Standard Deviation 0.188
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry
CD8+CD69+GrzA+GrzB+Prf+, baseline
|
0.00 cells/million T-cells
Standard Deviation 0.000
|
0.17 cells/million T-cells
Standard Deviation 0.345
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry
CD8+CD69+GrzA+GrzB+Prf+, CFB Week 2 post last dose
|
0.48 cells/million T-cells
Standard Deviation 0.282
|
0.20 cells/million T-cells
Standard Deviation 0.471
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry
CD8+CD38+GrzA+GrzB+Prf+, baseline
|
0.00 cells/million T-cells
Standard Deviation 0.000
|
0.14 cells/million T-cells
Standard Deviation 0.163
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry
CD8+CD38+GrzA+GrzB+Prf+, CFB Week 2 post last dose
|
0.89 cells/million T-cells
Standard Deviation 0.457
|
0.26 cells/million T-cells
Standard Deviation 0.555
|
SECONDARY outcome
Timeframe: At baseline and Week 2 post last dosePopulation: ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point.
A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=5 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=15 Participants
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry
CD8+CD137+GrzA+GrzB+Prf+, baseline
|
0.00 cells/million T-cells
Standard Deviation 0.000
|
0.05 cells/million T-cells
Standard Deviation 0.070
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry
CD8+CD137+GrzA+GrzB+Prf+,CFB Week 2 post last dose
|
0.09 cells/million T-cells
Standard Deviation 0.073
|
0.07 cells/million T-cells
Standard Deviation 0.089
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry
CD8+CD69+GrzA+GrzB+Prf+, baseline
|
0.00 cells/million T-cells
Standard Deviation 0.000
|
0.10 cells/million T-cells
Standard Deviation 0.158
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry
CD8+CD69+GrzA+GrzB+Prf+, CFB Week 2 post last dose
|
0.20 cells/million T-cells
Standard Deviation 0.283
|
0.34 cells/million T-cells
Standard Deviation 0.540
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry
CD8+CD38+GrzA+GrzB+Prf+, baseline
|
0.00 cells/million T-cells
Standard Deviation 0.000
|
0.06 cells/million T-cells
Standard Deviation 0.135
|
|
Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry
CD8+CD38+GrzA+GrzB+Prf+, CFB Week 2 post last dose
|
0.73 cells/million T-cells
Standard Deviation 0.841
|
0.36 cells/million T-cells
Standard Deviation 0.552
|
SECONDARY outcome
Timeframe: At screening and post-surgeryPopulation: ANoD population included all participants who received their assigned number of doses of study treatment plus EP.
The difference in means (post-surgery minus screening) for tumor-infiltrating lymphocytes (TILs) such as CD8, FoxP3, and perforin was analyzed using immunohistochemistry staining techniques.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=4 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC)
CD8
|
268.5 positive cells per square millimeter
Interval -1583.5 to 2120.5
|
—
|
|
Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC)
FoxP3
|
-79.8 positive cells per square millimeter
Interval -834.2 to 674.7
|
—
|
|
Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC)
Perforin
|
9.5 positive cells per square millimeter
Interval -0.4 to 19.4
|
—
|
SECONDARY outcome
Timeframe: At screening and post-surgeryPopulation: ANoD population included all participants who received their assigned number of doses of study treatment plus EP.
The difference in means (post-surgery minus screening) for the CD8/FoxP3 ratio was analyzed using immunohistochemistry staining techniques.
Outcome measures
| Measure |
Cohort 1: Surgery Cohort
n=4 Participants
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Mean Difference in CD8/FoxP3 Ratio in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC)
|
0.2 ratio
Interval -0.8 to 1.2
|
—
|
SECONDARY outcome
Timeframe: Up to 6 months post last dosePopulation: Data was not collected due to lack of recoverable samples sufficient for analysis
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Surgery Cohort
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2: Chemoradiation
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Surgery Cohort
n=6 participants at risk
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=16 participants at risk
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
Other adverse events
| Measure |
Cohort 1: Surgery Cohort
n=6 participants at risk
Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device.
|
Cohort 2: Chemoradiation
n=16 participants at risk
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Endocrine disorders
Thyroiditis
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Eye disorders
Diplopia
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Eye disorders
Retinal Detachment
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
2/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
3/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6 • Up to 6 months post last dose
|
18.8%
3/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Glossodynia
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Odynophagia
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Oral Discomfort
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Salivary Duct Inflammation
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Tongue Discolouration
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Tongue Oedema
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
General disorders
Chest Pain
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
General disorders
Fatigue
|
33.3%
2/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
General disorders
Injection Site Bruising
|
33.3%
2/6 • Up to 6 months post last dose
|
18.8%
3/16 • Up to 6 months post last dose
|
|
General disorders
Injection Site Erythema
|
33.3%
2/6 • Up to 6 months post last dose
|
31.2%
5/16 • Up to 6 months post last dose
|
|
General disorders
Injection Site Induration
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
General disorders
Injection Site Pain
|
83.3%
5/6 • Up to 6 months post last dose
|
62.5%
10/16 • Up to 6 months post last dose
|
|
General disorders
Injection Site Swelling
|
16.7%
1/6 • Up to 6 months post last dose
|
25.0%
4/16 • Up to 6 months post last dose
|
|
General disorders
Localised Oedema
|
33.3%
2/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
General disorders
Mucosal Inflammation
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Infections and infestations
Epididymitis
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Infections and infestations
Furuncle
|
33.3%
2/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Infections and infestations
Herpes Zoster
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Infections and infestations
Oral Candidiasis
|
16.7%
1/6 • Up to 6 months post last dose
|
12.5%
2/16 • Up to 6 months post last dose
|
|
Infections and infestations
Oral Herpes
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Infections and infestations
Staphylococcal Infection
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Investigations
Blood Creatinine Increased
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Investigations
Weight Decreased
|
33.3%
2/6 • Up to 6 months post last dose
|
12.5%
2/16 • Up to 6 months post last dose
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
33.3%
2/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
33.3%
2/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Trigger Finger
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up to 6 months post last dose
|
12.5%
2/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Neuropathy Peripheral
|
16.7%
1/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Up to 6 months post last dose
|
12.5%
2/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
50.0%
3/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia Areata
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Skin Fibrosis
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Surgical and medical procedures
Skin Neoplasm Excision
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/6 • Up to 6 months post last dose
|
6.2%
1/16 • Up to 6 months post last dose
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Up to 6 months post last dose
|
0.00%
0/16 • Up to 6 months post last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER