Trial Outcomes & Findings for Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies (NCT NCT03663712)
NCT ID: NCT03663712
Last Updated: 2024-11-20
Results Overview
Number of participants who experienced a dose limiting toxicity (DLT)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
from start of treatment until 30-day follow-up visit, up to 14 weeks
Results posted on
2024-11-20
Participant Flow
Subjects were recruited at 3 sites (Duke University Medical Center, University of Illinois at Chicago, and Wake Forest Baptist Medical Center).
28 subjects signed the consent form. 9 failed screening and were withdrawn from the study. 1 voluntarily withdrew from the study before getting the study drug. 18 of them received the study drug and are considered evaluable subjects.
Participant milestones
| Measure |
Dose Level 1
4 x 10\^6 Plaque Forming Units (PFU) of talimogene laherparepvec.
|
Dose Level 2
4 x 10\^7 Plaque Forming Units (PFU) of talimogene laherparepvec.
|
Dose Level 3
4 x 10\^8 Plaque Forming Units (PFU) of talimogene laherparepvec.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
11
|
|
Overall Study
COMPLETED
|
3
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
4 x 10\^6 PFU of talimogene laherparepvec.
|
Dose Level 2
n=4 Participants
4 x 10\^7 PFU of talimogene laherparepvec.
|
Dose Level 3
n=11 Participants
4 x 10\^8 PFU of talimogene laherparepvec.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: from start of treatment until 30-day follow-up visit, up to 14 weeksNumber of participants who experienced a dose limiting toxicity (DLT)
Outcome measures
| Measure |
TVEC Dose of 4x10^6 PFU (Plaque-forming Units)
n=3 Participants
Dose level 1. Subjects were assigned to receive 4 x 10\^6 PFU of talimogene laherparepvec.
|
TVEC Dose of 4x10^7 PFU (Plaque-forming Units)
n=4 Participants
Dose level 2. Subjects were assigned to receive 4 x 10\^7 PFU of talimogene laherparepvec.
|
TVEC Dose of 4x10^8 PFU (Plaque-forming Units)
n=11 Participants
Dose level 3. Subjects were assigned to receive 4 x 10\^8 PFU of talimogene laherparepvec.
|
|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 4 deaths
Dose Level 3
Serious events: 3 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
4x10\^6 PFU of talimogene laherparepvec.
|
Dose Level 2
n=4 participants at risk
4 x 10\^7 PFU of talimogene laherparepvec.
|
Dose Level 3
n=11 participants at risk
4 x 10\^8 PFU of talimogene laherparepvec.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
25.0%
1/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
intraperitoneal port obstruction
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
25.0%
1/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
failure to thrive
|
33.3%
1/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Infections and infestations
peritoneal port infection
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
25.0%
1/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
4x10\^6 PFU of talimogene laherparepvec.
|
Dose Level 2
n=4 participants at risk
4 x 10\^7 PFU of talimogene laherparepvec.
|
Dose Level 3
n=11 participants at risk
4 x 10\^8 PFU of talimogene laherparepvec.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
18.2%
2/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
25.0%
1/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
72.7%
8/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
50.0%
2/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
27.3%
3/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
18.2%
2/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
50.0%
2/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
General disorders
Fatigue
|
33.3%
1/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
50.0%
2/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
18.2%
2/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
General disorders
Fever
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
50.0%
2/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
27.3%
3/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
9.1%
1/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
25.0%
1/4 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
0.00%
0/11 • From start of treatment until 30-day follow-up visit, up to 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place