Trial Outcomes & Findings for The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (NCT NCT03444376)
NCT ID: NCT03444376
Last Updated: 2025-07-30
Results Overview
Patient will be evaluated for the first 21 days for dose-limiting toxicities.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
within 21days
Results posted on
2025-07-30
Participant Flow
A total of 90 subjects were enrolled, of which 25 subjects were considered as screen failures. Of 90 Screened, 65 met Inclusion/Exclusion Criteria and were Randomized to treatment.
Subjects were enrolled in three Parts; 6 subjects in Part A, 31 subjects in Part B (6 rolled over from Part A to Part B) and 65 subjects in Part C (6 rolled over from Part A and 25 from Part B) were enrolled. Of the 25 subjects enrolled during Part B period, 1 subject completed Part B and rolled over to Part C to continue the study, but died during Part C period. Therefore, this subject was counted as 'Completed' for Part B period, but 'Not Completed due to Death' for Part C period.
Participant milestones
| Measure |
Single Arm (GX-188E + Pembrolizumab)
Assigned Participants: 65 subjects
Intervention: Receiving GX-188E at 2 mg (1mg/site x 2 vaccination sites) at week 1, 2, 4, 7, 13, 19, 46 and 200 mg Pembrolizumab on Day 1 q3 weeks.
Design: In Part A, the first 6 subjects were enrolled and evaluated for the first 3 weeks for DLTs. No additional subjects were enrolled until all subjects in Part A completed the DLT window and the treatment regimen was deemed safe. If none or only 1 of the first 6 subjects experienced a DLT the study was moved into Part B.
Part B employed a Simon Two-Stage design to evaluate the anti-tumor efficacy of the GX-188E + pembrolizumab at the recommended Phase 2 schedule established as tolerable in Part A. In Stage 1 of Part B, 15 subjects were treated. These might have included any subjects from Part A, who did not experience a DLT, received the recommended Phase 2 treatment regimen, and who were considered evaluable for efficacy. If at least 3 efficacy evaluable subjects from Part B Stage 1 had objective responses within the first 24 weeks of treatment, an additional 13 subjects were enrolled, for a total of 28 efficacy evaluable subjects.
For Part C, if at least 8 of the 28 subjects enrolled in Part B, experienced an objective response who were considered evaluable for efficacy, it was considered that ORR satisfied the criteria for study expansion and additional subjects were enrolled in Part C to evaluate the efficacy further in larger population.
|
|---|---|
|
Part A
STARTED
|
6
|
|
Part A
COMPLETED
|
2
|
|
Part A
NOT COMPLETED
|
4
|
|
Part B
STARTED
|
31
|
|
Part B
COMPLETED
|
8
|
|
Part B
NOT COMPLETED
|
23
|
|
Part C
STARTED
|
65
|
|
Part C
COMPLETED
|
12
|
|
Part C
NOT COMPLETED
|
53
|
Reasons for withdrawal
| Measure |
Single Arm (GX-188E + Pembrolizumab)
Assigned Participants: 65 subjects
Intervention: Receiving GX-188E at 2 mg (1mg/site x 2 vaccination sites) at week 1, 2, 4, 7, 13, 19, 46 and 200 mg Pembrolizumab on Day 1 q3 weeks.
Design: In Part A, the first 6 subjects were enrolled and evaluated for the first 3 weeks for DLTs. No additional subjects were enrolled until all subjects in Part A completed the DLT window and the treatment regimen was deemed safe. If none or only 1 of the first 6 subjects experienced a DLT the study was moved into Part B.
Part B employed a Simon Two-Stage design to evaluate the anti-tumor efficacy of the GX-188E + pembrolizumab at the recommended Phase 2 schedule established as tolerable in Part A. In Stage 1 of Part B, 15 subjects were treated. These might have included any subjects from Part A, who did not experience a DLT, received the recommended Phase 2 treatment regimen, and who were considered evaluable for efficacy. If at least 3 efficacy evaluable subjects from Part B Stage 1 had objective responses within the first 24 weeks of treatment, an additional 13 subjects were enrolled, for a total of 28 efficacy evaluable subjects.
For Part C, if at least 8 of the 28 subjects enrolled in Part B, experienced an objective response who were considered evaluable for efficacy, it was considered that ORR satisfied the criteria for study expansion and additional subjects were enrolled in Part C to evaluate the efficacy further in larger population.
|
|---|---|
|
Part A
Disease relapse or Progression
|
1
|
|
Part A
Withdrawal by Subject
|
2
|
|
Part A
Adverse Event
|
1
|
|
Part B
Disease relapse or Progression
|
18
|
|
Part B
Withdrawal by Subject
|
2
|
|
Part B
Adverse Event
|
2
|
|
Part B
Physician Decision
|
1
|
|
Part C
Disease relapse or Progression
|
43
|
|
Part C
Withdrawal by Subject
|
5
|
|
Part C
Adverse Event
|
2
|
|
Part C
Physician Decision
|
2
|
|
Part C
Death
|
1
|
Baseline Characteristics
Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
Baseline characteristics by cohort
| Measure |
GX-188E, KEYTRUDA®
n=65 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Age, Categorical
Part A · <=18 years
|
0 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part A · Between 18 and 65 years
|
5 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part A · >=65 years
|
1 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part B · <=18 years
|
0 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part B · Between 18 and 65 years
|
29 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part B · >=65 years
|
2 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part C · <=18 years
|
0 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part C · Between 18 and 65 years
|
59 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Age, Categorical
Part C · >=65 years
|
6 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled
|
|
Sex: Female, Male
Female
|
65 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=65 Participants
|
|
PD-L1 expression status
Part A · Positive (≥1 CPS)
|
0 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
PD-L1 expression status
Part A · Negative (<1 CPS)
|
6 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
PD-L1 expression status
Part B · Positive (≥1 CPS)
|
15 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
PD-L1 expression status
Part B · Negative (<1 CPS)
|
16 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
PD-L1 expression status
Part C · Positive (≥1 CPS)
|
39 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
PD-L1 expression status
Part C · Negative (<1 CPS)
|
26 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
Histologic Type
Part A · Squamous Cell Carcinoma
|
3 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
Histologic Type
Part A · Adenocarcinoma
|
3 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
Histologic Type
Part B · Squamous Cell Carcinoma
|
23 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
Histologic Type
Part B · Adenocarcinoma
|
8 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
Histologic Type
Part C · Squamous Cell Carcinoma
|
50 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
Histologic Type
Part C · Adenocarcinoma
|
15 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
HPV type
Part A · HPV-16
|
3 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
HPV type
Part A · HPV-18 or both
|
3 Participants
n=6 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
HPV type
Part B · HPV-16
|
24 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
HPV type
Part B · HPV-18 or both
|
7 Participants
n=31 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
HPV type
Part C · HPV-16
|
49 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
|
HPV type
Part C · HPV-18 or both
|
16 Participants
n=65 Participants • Six subjects in Part A, 31 subjects in Part B (6 subjects rolled over from Part A to Part B) and 65 subjects in Part C (6 subjects rolled over from Part A and 25 subjects from Part B) were enrolled.
|
PRIMARY outcome
Timeframe: within 21daysPopulation: The first 6 subjects (Part A) were enrolled and evaluated for the first 3 weeks (prior to Week 4 Day 1 visit) for DLTs. No additional subjects were enrolled until all subjects in Part A completed the DLT window and the investigational treatment regimen was deemed safe.
Patient will be evaluated for the first 21 days for dose-limiting toxicities.
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=6 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
DLT Evaluation for Safety and Tolerability(Part A)
|
0 participants
|
PRIMARY outcome
Timeframe: within 24 weeksPopulation: All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B).
ORR within 24 weeks (ORR24) evaluated by RECIST v1.1
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=60 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
ORR for Efficacy (Part B&C)
Part B
|
41.4 percentage of responders
Interval 25.89 to 100.0
|
|
ORR for Efficacy (Part B&C)
Part C
|
35.0 percentage of responders
Interval 22.93 to 47.07
|
SECONDARY outcome
Timeframe: within 24 weeksPopulation: All efficacy analyses were carried out using the 60 in the Efficacy Evaluable Population, respectively, and ORR24 analysis was performed for 6 subjects in the Part A group.
Overall Response Rate within 24 weeks (ORR24) by RECIST v1.1 and immune-related Response Criteria (irRC)
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=6 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
ORR for Efficacy (Part A)
|
50.0 percentage of responders
Interval 11.81 to 88.19
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B).
Best Overall Response Rate(BORR) by RECIST v1.1
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=60 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
BORR (Part B&C)
Part A
|
50.0 percentage of responders
Interval 11.81 to 88.19
|
|
BORR (Part B&C)
Part B
|
41.4 percentage of responders
Interval 23.52 to 61.06
|
|
BORR (Part B&C)
Part C
|
35.0 percentage of responders
Interval 22.93 to 47.07
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B).
Time-to-Best Response by RECIST v1.1 and iRECIST
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=60 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Time-to-Best Response
Part A
|
2.07 Months
Interval 2.07 to
Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
|
Time-to-Best Response
Part B
|
2.10 Months
Interval 2.04 to 4.01
|
|
Time-to-Best Response
Part C
|
2.10 Months
Interval 2.07 to 3.02
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B).
Duration of Response (DOR) by RECIST v1.1 and iRECIST
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=60 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Duration of Response (DOR)
Part A
|
NA Months
Interval 2.4 to
Median and Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
|
Duration of Response (DOR)
Part B
|
5.78 Months
Interval 2.4 to
Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
|
Duration of Response (DOR)
Part C
|
NA Months
Interval 5.32 to
Median and Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B).
6month- PFS by RECIST v1.1 and iRECIST
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=60 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Progression-Free Survival (PFS)
Part A
|
4.25 Months
Interval 2.04 to
Upper limit of 95% CI could not be calculated due to low number of participants with events.
|
|
Progression-Free Survival (PFS)
Part B
|
4.14 Months
Interval 2.07 to 8.38
|
|
Progression-Free Survival (PFS)
Part C
|
4.40 Months
Interval 2.14 to 8.31
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: All efficacy analyses included 60 subjects from the Efficacy Evaluable Population. Safety analyses included 65 subjects. Five subjects were excluded from efficacy analysis for receiving less than 45 days of treatment without experiencing any DLT. The efficacy population comprised 6 subjects in Part A, 29 in Part B (including 6 from Part A), and 60 in Part C (including 6 from Part A and 23 from Part B).
Overall Survival (OS) by RECIST v1.1 and iRECIST
Outcome measures
| Measure |
GX-188E, KEYTRUDA®
n=60 Participants
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Overall Survival (OS)
Part A
|
15.54 Months
Interval 3.48 to
Due to low number of events, the upper limit of 95% CI from Kaplan-Meier survival curves could not derived.
|
|
Overall Survival (OS)
Part B
|
14.42 Months
Interval 8.97 to
Due to low number of events, the upper limit of 95% CI from Kaplan-Meier survival curves could not derived.
|
|
Overall Survival (OS)
Part C
|
23.79 Months
Interval 14.03 to
Due to low number of events, the upper limit of 95% CI from Kaplan-Meier survival curves could not derived.
|
Adverse Events
GX-188E, KEYTRUDA®
Serious events: 25 serious events
Other events: 54 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
GX-188E, KEYTRUDA®
n=65 participants at risk
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
10.8%
7/65 • 24 months
|
|
Infections and infestations
Pneumonia
|
3.1%
2/65 • 24 months
|
|
Infections and infestations
Appendicitis
|
1.5%
1/65 • 24 months
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/65 • 24 months
|
|
Infections and infestations
Kidney infection
|
1.5%
1/65 • 24 months
|
|
Infections and infestations
Lymphangitis
|
1.5%
1/65 • 24 months
|
|
Infections and infestations
Ophthalmic herpes zoster
|
1.5%
1/65 • 24 months
|
|
Investigations
Peritonitis
|
1.5%
1/65 • 24 months
|
|
General disorders
Pyrexia
|
4.6%
3/65 • 24 months
|
|
General disorders
Asthenia
|
3.1%
2/65 • 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/65 • 24 months
|
|
Renal and urinary disorders
Azotaemia
|
1.5%
1/65 • 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
1.5%
1/65 • 24 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.5%
1/65 • 24 months
|
|
Renal and urinary disorders
Urogenital fistula
|
1.5%
1/65 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • 24 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.5%
1/65 • 24 months
|
|
Gastrointestinal disorders
Haematochezia
|
1.5%
1/65 • 24 months
|
|
Gastrointestinal disorders
Mechanical ileus
|
1.5%
1/65 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/65 • 24 months
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/65 • 24 months
|
|
Investigations
Blood creatinine increased
|
1.5%
1/65 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/65 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
1.5%
1/65 • 24 months
|
|
Reproductive system and breast disorders
Vaginal fistula
|
1.5%
1/65 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.5%
1/65 • 24 months
|
Other adverse events
| Measure |
GX-188E, KEYTRUDA®
n=65 participants at risk
GX-188E: 1st day of week 1,2,4,7,13,19, 46/ 2mg KEYTRUDA® : Day 1 q3 weeks/ 200mg
GX-188E: GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
KEYTRUDA®: pembrolizumab(100mg/4mL/vial), Intravenous administration
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
6/65 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
10.8%
7/65 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
7/65 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
9.2%
6/65 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
9.2%
6/65 • 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
4.6%
3/65 • 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
2/65 • 24 months
|
|
Gastrointestinal disorders
Chronic gastritis
|
3.1%
2/65 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
9.2%
6/65 • 24 months
|
|
Infections and infestations
Herpes zoster
|
6.2%
4/65 • 24 months
|
|
Infections and infestations
Pneumonia
|
4.6%
3/65 • 24 months
|
|
Infections and infestations
Conjunctivitis
|
3.1%
2/65 • 24 months
|
|
Infections and infestations
Cystitis
|
4.6%
3/65 • 24 months
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
2/65 • 24 months
|
|
Investigations
Blood creatinine increased
|
12.3%
8/65 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
5/65 • 24 months
|
|
Investigations
Aspartate aminotransferase increased 0
|
7.7%
5/65 • 24 months
|
|
Investigations
Neutrophil count decreased
|
4.6%
3/65 • 24 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.1%
2/65 • 24 months
|
|
Investigations
Weight decreased
|
3.1%
2/65 • 24 months
|
|
General disorders
Pyrexia
|
12.3%
8/65 • 24 months
|
|
General disorders
Asthenia
|
7.7%
5/65 • 24 months
|
|
General disorders
Fatigue
|
4.6%
3/65 • 24 months
|
|
General disorders
Oedema peripheral
|
4.6%
3/65 • 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.2%
6/65 • 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
4/65 • 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.2%
4/65 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.1%
2/65 • 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
2/65 • 24 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
2/65 • 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
29.2%
19/65 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.3%
8/65 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.6%
3/65 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
2/65 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
2/65 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.1%
2/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
4/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
4/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
2/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.6%
3/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.1%
2/65 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
2/65 • 24 months
|
|
Nervous system disorders
Dizziness
|
6.2%
4/65 • 24 months
|
|
Nervous system disorders
Headache
|
7.7%
5/65 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
5/65 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
4/65 • 24 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.6%
3/65 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.6%
3/65 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
15.4%
10/65 • 24 months
|
|
Endocrine disorders
Thyroiditis
|
4.6%
3/65 • 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
2/65 • 24 months
|
|
Renal and urinary disorders
Hydronephrosis
|
3.1%
2/65 • 24 months
|
|
Renal and urinary disorders
Haematuria
|
4.6%
3/65 • 24 months
|
|
Eye disorders
Dry eye
|
4.6%
3/65 • 24 months
|
|
Vascular disorders
Lymphoedema
|
7.7%
5/65 • 24 months
|
|
Vascular disorders
Hypertension
|
3.1%
2/65 • 24 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.1%
2/65 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place