Trial Outcomes & Findings for Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma (NCT NCT04006119)
NCT ID: NCT04006119
Last Updated: 2025-04-18
Results Overview
Evaluation of adverse events as assessed by CTCAE v5.0 will be based on the incidence, intensity and type of adverse event. Safety evaluations included the observed incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of toxicity Grade \>3, TEAEs leading to treatment dose modification, discontinuation, and death. Drug-related TEAEs were also assessed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
2.0 yrs
Results posted on
2025-04-18
Participant Flow
Participant milestones
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
Run in Cemiplimab Period
STARTED
|
40
|
|
Run in Cemiplimab Period
COMPLETED
|
39
|
|
Run in Cemiplimab Period
NOT COMPLETED
|
1
|
|
End of Treatment Veledimex
STARTED
|
39
|
|
End of Treatment Veledimex
COMPLETED
|
37
|
|
End of Treatment Veledimex
NOT COMPLETED
|
2
|
|
Adjuvant Cemiplimab Period
STARTED
|
37
|
|
Adjuvant Cemiplimab Period
COMPLETED
|
0
|
|
Adjuvant Cemiplimab Period
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
Run in Cemiplimab Period
Lack of Efficacy
|
1
|
|
End of Treatment Veledimex
Adverse Event
|
2
|
|
Adjuvant Cemiplimab Period
Lack of Efficacy
|
28
|
|
Adjuvant Cemiplimab Period
Adverse Event
|
3
|
|
Adjuvant Cemiplimab Period
Withdrawal by Subject
|
4
|
|
Adjuvant Cemiplimab Period
Sponsor Study Termination rollover to Compassionate Use
|
2
|
Baseline Characteristics
Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma
Baseline characteristics by cohort
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=40 Participants
Intratumoral Ad-RTS-hIL-12 and oral veledimex (activator ligand, 20mg) given in combination with cemiplimab-rwlc via infusion.
Ad-RTS-hIL-12: - intratumoral injection of Ad-RTS-hIL-12
\- 2.0 x 10\^11 viral particles (vp) per injection
Veledimex: 20mg/day 15 oral daily doses of veledimex
Cemiplimab-Rwlc: Infusion every 3 weeks (350mg)
|
|---|---|
|
Age, Continuous
|
58 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
|
Unifocal Disease
|
33 Participants
n=5 Participants
|
|
Isocitrate Dehydrogenase wild type (WT)
|
37 Participants
n=5 Participants
|
|
O6-methlyguanine-DNA methyltransferase (MGMT) unmethylated
|
28 Participants
n=5 Participants
|
|
Karnofsky performance score (KPS) ≥90
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.0 yrsPopulation: The Full Analysis Set (FAS) includes every subject who received at least one dose of any study drug recorded in the Data Management database excluding screen failures. The Evaluable Safety Population (ESP) is a subset of the FAS. Regardless of major protocol deviations, these subjects have received at least one of the following: * Day -7 of cemiplimab, * the injection of Ad-RTS-hIL-12 with at least one post IL-12 dose of veledimex, * and at least one post IL-12 dose of cemiplimab (Day 15).
Evaluation of adverse events as assessed by CTCAE v5.0 will be based on the incidence, intensity and type of adverse event. Safety evaluations included the observed incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of toxicity Grade \>3, TEAEs leading to treatment dose modification, discontinuation, and death. Drug-related TEAEs were also assessed.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=40 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any TEAE
|
39 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Serious TEAE
|
28 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any TEAE with Toxicity Grade >/= 3
|
32 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any TEAE Leading to Treatment Discontinuation
|
5 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any TEAE Leading to Death (Progressive Disease)
|
8 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Drug-Related TEAE
|
39 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Drug-Related Serious TEAE
|
10 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Drug-Related TEAE with Toxicity Grade >/=3
|
20 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Drug-Related TEAE Leading to Treatment Dose Modification
|
11 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Drug-Related TEAE Leading to Treatment Discontinuation
|
3 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Any Drug-Related TEAE Leading to Death
|
0 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Ad-RTS-hIL-12 + Veledimex Related TEAEs
|
35 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Ad-RTS-hIL-12 + Veledimex Related Serious TEAEs
|
9 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Ad-RTS-hIL-12 + Veledimex Related TEAEs with Toxicity Grade >/= 3
|
17 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Ad-RTS-hIL-12 + Veledimex TEAEs Leading to Treatment Dose Modification
|
8 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Ad-RTS-hIL-12 + Veledimex TEAEs Leading to Treatment Discontinuation
|
2 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Ad-RTS-hIL-12 + Veledimex Related TEAEs Leading to Death
|
0 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Cemiplimab Related TEAEs
|
34 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Cemiplimab Related Serious TEAEs
|
6 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Cemiplimab Related TEAEs with Toxicity Grade >/= 3
|
17 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Cemiplimab Related TEAEs Leading to Treatment Dose Modification
|
3 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Cemiplimab Related TEAEs Leading to Treatment Discontinuation
|
1 participants
|
|
Safety of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
Cemiplimab Related TEAEs Leading to Death
|
0 participants
|
PRIMARY outcome
Timeframe: 2.0 yrsPopulation: The per protocol population will comprise subjects who have received Day -7 of cemiplimab, the injection of Ad-RTS-hIL-12 with at least one post IL-12 dose of veledimex, at least one post IL-12 dose of cemiplimab (e.g. Day 15), and who have not had a major protocol deviation for which the key efficacy endpoints could be regarded as confounded or uninterpretable. Subjects who have had minor protocol deviation(s) that are thought not to impact efficacy will be included in this analysis population.
Overall Survival (OS) OS is defined as the duration of time from the first dose of study drug (i.e., cemiplimab at Day -7) to the date of death from any cause. Censoring will be considered as below: * Subjects who discontinue study will be censored at date of discontinuation. * Subjects who are lost to follow-up will be censored at last follow-up contact date. * If the subject has not died, the subject is censored if still alive up to 2 years from the first dose of study drug received.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=37 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
Efficacy of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex in Combination With Cemiplimab-rwlc in Subjects With Recurrent or Progressive Glioblastoma.
|
12.09 Months
Interval 8.38 to 16.66
|
SECONDARY outcome
Timeframe: From Day 0 through 18 months post first dose of study treatmentPopulation: The population will comprise subjects who have received Day -7 of cemiplimab, the injection of Ad-RTS-hIL-12 with at least one post IL-12 dose of veledimex, at least one post IL- 12 dose of cemiplimab (e.g., Day 15), and who have not had a major protocol deviation for which the key efficacy endpoints could be regarded as confounded or uninterpretable. Estimates of the OS at prespecified timepoints will be based on the per protocol (PP) population.
Given the early closure of the study and survival follow-up data limited to one year post last patient in, complete assessment of efficacy could not be determined. Number of participants with death prior to each time point (6, 12, and 18 months) is reported here.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=37 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
To Determine the Survival Rates at 6, 12, and 18 Months
Death prior to 12 months
|
19 participants
|
|
To Determine the Survival Rates at 6, 12, and 18 Months
Death prior to 18 months
|
24 participants
|
|
To Determine the Survival Rates at 6, 12, and 18 Months
Death prior to 6 months
|
8 participants
|
SECONDARY outcome
Timeframe: 2.0 yrsPopulation: The per protocol population comprised subjects who had received Day -7 of cemiplimab, the injection of Ad-RTS-hIL-12 with at least 1 post IL-12 dose of veledimex, at least 1 post IL-12 dose of cemiplimab (e.g., Day 15), and who had not had a major protocol deviation for which the key efficacy endpoints could be regarded as confounded or uninterpretable. Subjects who have had minor protocol deviation(s) that are thought not to impact efficacy were included in this analysis population.
Given the early closure of the study, formal assessment of PFS using Kaplan Meier Product-Line method was not performed. Mean time to disease progression (or participant's last scan) is reported here.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=39 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
To Determine the Progression Free Survival (PFS)
|
89.0 Days
Standard Deviation 95.6
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Given the early closure of the study complete assessment of efficacy could not be determined. The per protocol population will comprise subjects who have received Day -7 of cemiplimab, the injection of Ad-RTS-hIL-12 with at least one post IL-12 dose of veledimex, at least one post IL-12 dose of cemiplimab (e.g., Day 15), and who have not had a major protocol deviation for which the key efficacy endpoints could be regarded as confounded or uninterpretable.
Given the early closure of the study complete assessment of efficacy could not be determined. Reported below is the PSP at anytime while on study.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=37 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
To Determine the Rate of Pseudoprogression (PSP) at 6, 12, 18 and 24 Months
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The per protocol population will comprise subjects who have received Day -7 of cemiplimab, the injection of Ad-RTS-hIL-12 with at least one post IL-12 dose of veledimex, at least one post IL-12 dose of cemiplimab (e.g., Day 15), and who have not had a major protocol deviation for which the key efficacy endpoints could be regarded as confounded or uninterpretable.
Tumor response will be defined by radiographic and clinical criteria. Complete response (CR) or partial response (PR) will be first assessed by radiographic changes that indicate a reduction of bi-dimensional tumor size as per Recist 1.1 criteria. In addition, changes in neurologic function and steroid use will be considered to determine stable disease (SD).Given the early closure of the study complete assessment of efficacy could not be determined. The results below report response at anytime while on study.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=37 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
To Determine the Investigator's Assessment of Response, Including Tumor Objective Response Rate (ORR) at 6, 12, 18 and 24 Months
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Given the early closure of the study and survival follow-up data limited to one year post last patient in, complete assessment of efficacy could not be determined.
Given the early closure of the study and survival follow-up data limited to one year post last patient in, complete assessment of efficacy could not be determined. The IRANO results below report response at anytime while on study.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=37 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
To Determine the Tumor Response Rates at 6, 12, 18 and 24 Months
|
3 Participants
|
SECONDARY outcome
Timeframe: Screening through Day 28 (assessed at Screening and Days 0, 1, 3, 7, 14, and 28)Population: The biomarker-evaluable population includes all ESP subjects who have adequate biomarker sample(s) at screening (baseline) and at least one follow-up assessment
Immune cell population markers, such as cluster of differentiation (CD) antigens CD3+CD4+ and CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo-, were assessed.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=29 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Screening
|
40.85 % of total lymphocytes
Standard Deviation 10.42
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Day 0
|
40.26 % of total lymphocytes
Standard Deviation 11.28
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Day 1
|
35.36 % of total lymphocytes
Standard Deviation 12.38
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Day 3
|
46.85 % of total lymphocytes
Standard Deviation 12.38
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Day 7
|
39.96 % of total lymphocytes
Standard Deviation 7.81
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Day 14
|
33.00 % of total lymphocytes
Standard Deviation 12.28
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+CD4+ at Day 28
|
37.17 % of total lymphocytes
Standard Deviation 11.54
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Screening
|
0.67 % of total lymphocytes
Standard Deviation 0.60
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Day 0
|
0.82 % of total lymphocytes
Standard Deviation 0.64
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Day 1
|
0.44 % of total lymphocytes
Standard Deviation 0.46
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Day 3
|
1.02 % of total lymphocytes
Standard Deviation 0.81
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Day 7
|
0.55 % of total lymphocytes
Standard Deviation 0.51
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Day 14
|
0.50 % of total lymphocytes
Standard Deviation 0.49
|
|
Changes From Baseline in Cellular Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
CD3+/ CD4+/ CD25hi/ Foxp3+/ CD127lo- at Day 28
|
0.48 % of total lymphocytes
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Screening through Day 28 (assessed at Screening and Days 0, 1, 3, 7, 14, and 28)Population: The biomarker-evaluable population includes all Evaluable Safety Population (ESP) subjects who have adequate biomarker sample(s) at screening (baseline) and at least one follow-up assessment. Individual samples that were below the limit of quantitation were considered 0.
Immunological and biological markers, such as levels of interleukin-12 (IL-12) and interferon gamma (IFN-γ) were assessed in serum samples.
Outcome measures
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=27 Participants
Subjects received cemiplimab-rwlc on Day -7 (run in). On Day 0 (day of Ad-RTS-hIL-12 administration) subjects took one dose of veledimex prior to injection of Ad-RTS-hIL-12. After the Ad-RTS-hIL-12 injection, veledimex will be administered orally for 14 days (end of treatment veledimex). Subjects then received a dose of cemiplimab-rwlc on Day 15 and every three weeks thereafter (Q3W) until confirmed progression by immunotherapy Response Assessment for Neuro Oncology (iRANO) criteria (adjuvant cemiplimab) .
|
|---|---|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Screening
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Day 0
|
0.11 pg/mL
Standard Deviation 0.58
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Day 1
|
0.18 pg/mL
Standard Deviation 0.83
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Day 3
|
10.53 pg/mL
Standard Deviation 20.34
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Day 7
|
6.43 pg/mL
Standard Deviation 13.12
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Day 14
|
0.74 pg/mL
Standard Deviation 2.04
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IFN-gamma at Day 28
|
10.07 pg/mL
Standard Deviation 42.86
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Screening
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Day 0
|
0.09 pg/mL
Standard Deviation 0.48
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Day 1
|
0.28 pg/mL
Standard Deviation 0.73
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Day 3
|
29.65 pg/mL
Standard Deviation 49.96
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Day 7
|
15.56 pg/mL
Standard Deviation 23.09
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Day 14
|
6.80 pg/mL
Standard Deviation 12.24
|
|
Changes From Baseline in Humoral Immune Responses Elicited by Ad-RTS-hIL-12 and Veledimex in Combination With Cemiplimab-rwlc
IL-12 at Day 28
|
31.06 pg/mL
Standard Deviation 131.49
|
Adverse Events
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
Serious events: 30 serious events
Other events: 39 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=40 participants at risk
Ad-RTS-hIL-12 and oral veledimex (activator ligand, 20 mg) given in combination with cemiplimab-rwlc via infusion. One dose of cemiplimab-rwlc on Day -7, then every 3 weeks starting on Day 15
|
|---|---|
|
Nervous system disorders
Aphasia
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Infections and infestations
Brain abscess
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Brain oedema
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Confusional state
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
COVID-19
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Immune system disorders
Cytokine release syndrome
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Disease progression
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Vascular disorders
Embolism
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Encephalopathy
|
12.5%
5/40 • Number of events 5 • 2 year
|
|
Gastrointestinal disorders
Enterocolitis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Gait disturbance
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Headache
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Nervous system disorders
Hemiparesis
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Hydrocephalus
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
12.5%
5/40 • Number of events 5 • 2 year
|
|
Infections and infestations
Meningitis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Mental disorder
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
Postoperative wound infection
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Seizure
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
Urosepsis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
Wound infection
|
2.5%
1/40 • Number of events 1 • 2 year
|
Other adverse events
| Measure |
Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc
n=40 participants at risk
Ad-RTS-hIL-12 and oral veledimex (activator ligand, 20 mg) given in combination with cemiplimab-rwlc via infusion. One dose of cemiplimab-rwlc on Day -7, then every 3 weeks starting on Day 15
|
|---|---|
|
Gastrointestinal disorders
Tongue geographic
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Transaminases increased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Abulia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Acidosis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Action tremor
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Asthenia
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 2 • 2 year
|
|
Psychiatric disorders
Agitation
|
7.5%
3/40 • Number of events 5 • 2 year
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
8/40 • Number of events 13 • 2 year
|
|
Investigations
Amylase increased
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
8/40 • Number of events 10 • 2 year
|
|
Endocrine disorders
Androgen deficiency
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Anxiety
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Nervous system disorders
Aphasia
|
45.0%
18/40 • Number of events 27 • 2 year
|
|
Nervous system disorders
Apraxia
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
6/40 • Number of events 6 • 2 year
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
8/40 • Number of events 9 • 2 year
|
|
Nervous system disorders
Ataxia
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Cardiac disorders
Atrial flutter
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
Bacteraemia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Balance disorder
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Investigations
Blood calcium decreased
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Investigations
Blood glucose increased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
17.5%
7/40 • Number of events 8 • 2 year
|
|
Investigations
Blood magnesium decreased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Blood phosphorus decreased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Blood potassium decreased
|
7.5%
3/40 • Number of events 4 • 2 year
|
|
Investigations
Blood pressure increased
|
2.5%
1/40 • Number of events 2 • 2 year
|
|
Investigations
Blood sodium decreased
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Investigations
Blood sodium increased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Cardiac disorders
Bradycardia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Brain oedema
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Chills
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Hepatobiliary disorders
Cholecystitis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Clumsiness
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Cognitive disorder
|
10.0%
4/40 • Number of events 5 • 2 year
|
|
Psychiatric disorders
Confusional state
|
20.0%
8/40 • Number of events 10 • 2 year
|
|
Gastrointestinal disorders
Constipation
|
40.0%
16/40 • Number of events 18 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
C-reactive protein increased
|
12.5%
5/40 • Number of events 6 • 2 year
|
|
Infections and infestations
Cystitis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Immune system disorders
Cytokine release syndrome
|
5.0%
2/40 • Number of events 4 • 2 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Delirium
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
General disorders
Device related thrombosis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
8/40 • Number of events 9 • 2 year
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Dizziness
|
17.5%
7/40 • Number of events 7 • 2 year
|
|
Eye disorders
Dry eye
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Nervous system disorders
Dysarthria
|
7.5%
3/40 • Number of events 4 • 2 year
|
|
Nervous system disorders
Dysgeusia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
4/40 • Number of events 6 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Ear and labyrinth disorders
Ear pruritus
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Encephalopathy
|
12.5%
5/40 • Number of events 5 • 2 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Facial paralysis
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Nervous system disorders
Facial paresis
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Injury, poisoning and procedural complications
Fall
|
17.5%
7/40 • Number of events 13 • 2 year
|
|
General disorders
Fatigue
|
35.0%
14/40 • Number of events 16 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Flatulence
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
General disorders
Gait disturbance
|
7.5%
3/40 • Number of events 4 • 2 year
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Eye disorders
Gaze palsy
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Renal and urinary disorders
Haematuria
|
5.0%
2/40 • Number of events 4 • 2 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
7.5%
3/40 • Number of events 4 • 2 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Hallucination
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Headache
|
57.5%
23/40 • Number of events 40 • 2 year
|
|
Nervous system disorders
Hemianopia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Hemianopia homonymous
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Hemiparesis
|
27.5%
11/40 • Number of events 18 • 2 year
|
|
Infections and infestations
Hordeolum
|
2.5%
1/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Hydrocephalus
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
10/40 • Number of events 21 • 2 year
|
|
Nervous system disorders
Hypersomnia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Vascular disorders
Hypertension
|
22.5%
9/40 • Number of events 10 • 2 year
|
|
Endocrine disorders
Hyperthyroidism
|
12.5%
5/40 • Number of events 5 • 2 year
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
10/40 • Number of events 15 • 2 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
27.5%
11/40 • Number of events 15 • 2 year
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
8/40 • Number of events 8 • 2 year
|
|
Vascular disorders
Hypotension
|
12.5%
5/40 • Number of events 6 • 2 year
|
|
Endocrine disorders
Hypothyroidism
|
22.5%
9/40 • Number of events 9 • 2 year
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Infections and infestations
Influenza
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Influenza like illness
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Psychiatric disorders
Insomnia
|
17.5%
7/40 • Number of events 7 • 2 year
|
|
Investigations
International normalised ratio increased
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Psychiatric disorders
Irritability
|
5.0%
2/40 • Number of events 4 • 2 year
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Lethargy
|
10.0%
4/40 • Number of events 5 • 2 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Lipase
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Lipase increased
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
General disorders
Localised oedema
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Lymphocyte count decreased
|
37.5%
15/40 • Number of events 41 • 2 year
|
|
Blood and lymphatic system disorders
Lymphopenia
|
15.0%
6/40 • Number of events 11 • 2 year
|
|
General disorders
Malaise
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Memory impairment
|
12.5%
5/40 • Number of events 5 • 2 year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Mutism
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Nausea
|
57.5%
23/40 • Number of events 34 • 2 year
|
|
Nervous system disorders
Nervous system disorder
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Neuralgia
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Nervous system disorders
Neurologic neglect syndrome
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Neutrophil count decreased
|
10.0%
4/40 • Number of events 5 • 2 year
|
|
Renal and urinary disorders
Nocturia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Occipital neuralgia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Oedema peripheral
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
Infections and infestations
Onychomycosis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
Otitis externa
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
General disorders
Pain
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Paraesthesia
|
10.0%
4/40 • Number of events 7 • 2 year
|
|
Reproductive system and breast disorders
Penile pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Peroneal nerve palsy
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Personality change
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Investigations
Platelet count decreased
|
12.5%
5/40 • Number of events 9 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Pneumocephalus
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Injury, poisoning and procedural complications
Procedural headache
|
17.5%
7/40 • Number of events 7 • 2 year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.5%
5/40 • Number of events 6 • 2 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
General disorders
Pyrexia
|
62.5%
25/40 • Number of events 40 • 2 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.0%
6/40 • Number of events 7 • 2 year
|
|
Investigations
Red blood cell sedimentation rate increased
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Investigations
Respiratory rate increased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Seizure
|
17.5%
7/40 • Number of events 7 • 2 year
|
|
Nervous system disorders
Sensory loss
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Cardiac disorders
Sinus bradycardia
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Cardiac disorders
Sinus tachycardia
|
7.5%
3/40 • Number of events 4 • 2 year
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.5%
1/40 • Number of events 2 • 2 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Somnolence
|
5.0%
2/40 • Number of events 3 • 2 year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Psychiatric disorders
Suicidal ideation
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Cardiac disorders
Tachycardia
|
10.0%
4/40 • Number of events 4 • 2 year
|
|
General disorders
Temperature intolerance
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
2/40 • Number of events 2 • 2 year
|
|
Nervous system disorders
Tremor
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Renal and urinary disorders
Urinary incontinence
|
7.5%
3/40 • Number of events 3 • 2 year
|
|
Renal and urinary disorders
Urinary retention
|
15.0%
6/40 • Number of events 8 • 2 year
|
|
Infections and infestations
Urinary tract infection
|
15.0%
6/40 • Number of events 9 • 2 year
|
|
Nervous system disorders
Visual field defect
|
12.5%
5/40 • Number of events 6 • 2 year
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
14/40 • Number of events 15 • 2 year
|
|
Investigations
Weight decreased
|
20.0%
8/40 • Number of events 10 • 2 year
|
|
Investigations
White blood cell count increased
|
2.5%
1/40 • Number of events 1 • 2 year
|
|
Infections and infestations
Wound infection
|
2.5%
1/40 • Number of events 1 • 2 year
|
Additional Information
Jaymes Holland, Clinical Consultant
Alaunos Therapeutics, Inc
Phone: 6502732627
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER