Trial Outcomes & Findings for Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma (NCT NCT03921073)
NCT ID: NCT03921073
Last Updated: 2022-11-01
Results Overview
Overall response rate is defined as the proportion of patients who demonstrate complete or partial responses in injected lesions per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria appropriate for cutaneous neoplasms (ORR=complete response + partial response).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
at 24 Weeks
Results posted on
2022-11-01
Participant Flow
Participant milestones
| Measure |
Intralesional Injection of T-VEC
Participants will undergo intralesional injections of up to 4 cc of 10\^6 plaque-forming units (PFU)/mL of T-VEC. Dose is dependent on the diameter of the lesions to be injected (volume injected is related to diameter of lesion(s) at time point 0). Three weeks later and every other week thereafter, the participants will be injected with up to 4 cc of 10\^8 PFU/mL, with dose dependent on the diameter of the lesion(s) to be injected. Participants may be treated for up to 12 months.
T-VEC: Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
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|---|---|
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Overall Study
STARTED
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5
|
|
Overall Study
COMPLETED
|
5
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of T-VEC in Locally Advanced Cutaneous Angiosarcoma
Baseline characteristics by cohort
| Measure |
Intralesional Injection of T-VEC
n=5 Participants
Participants will undergo intralesional injections of up to 4 cc of 10\^6 plaque-forming units (PFU)/mL of T-VEC. Dose is dependent on the diameter of the lesions to be injected (volume injected is related to diameter of lesion(s) at time point 0). Three weeks later and every other week thereafter, the participants will be injected with up to 4 cc of 10\^8 PFU/mL, with dose dependent on the diameter of the lesion(s) to be injected. Participants may be treated for up to 12 months.
T-VEC: Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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5 participants
n=5 Participants
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PRIMARY outcome
Timeframe: at 24 WeeksPopulation: Data not collected. 0 participants analyzed. Study terminated early.
Overall response rate is defined as the proportion of patients who demonstrate complete or partial responses in injected lesions per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria appropriate for cutaneous neoplasms (ORR=complete response + partial response).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 4 weeksPopulation: Data not collected. 0 participants analyzed. Study terminated early.
Response duration will be measured from the time of initial partial response or complete response until documented progression. The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Data not collected. 0 participants analyzed. Study terminated early.
Progression-free survival is defined as the period of time from the first injection to progression of disease or appearance of new cutaneous angiosarcomas that were not present at the time of study entry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: Data not collected. 0 participants analyzed. Study terminated early.
Complete response rate is defined as the proportion of participants that have lesions with complete clinical regression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: Data not collected. 0 participants analyzed. Study terminated early.
Measuring the rate of participants requiring surgical resection of T-VEC treated lesions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: Data not collected. 0 participants analyzed. Study terminated early.
Measuring the degree of immune infiltration in surgically resected T-VEC treated tumors
Outcome measures
Outcome data not reported
Adverse Events
Intralesional Injection of T-VEC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intralesional Injection of T-VEC
n=5 participants at risk
Participants will undergo intralesional injections of up to 4 cc of 10\^6 plaque-forming units (PFU)/mL of T-VEC. Dose is dependent on the diameter of the lesions to be injected (volume injected is related to diameter of lesion(s) at time point 0). Three weeks later and every other week thereafter, the participants will be injected with up to 4 cc of 10\^8 PFU/mL, with dose dependent on the diameter of the lesion(s) to be injected. Participants may be treated for up to 12 months.
T-VEC: Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
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|---|---|
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Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
40.0%
2/5 • Number of events 2 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Eye disorders
Periorbital edema
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Gastrointestinal disorders
Toothache
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
General disorders
Chills
|
40.0%
2/5 • Number of events 2 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 5 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 7 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
General disorders
Flu like symptoms
|
60.0%
3/5 • Number of events 30 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
General disorders
Injection site pain
|
60.0%
3/5 • Number of events 4 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Infections and infestations
Kidney infection
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
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Infections and infestations
Sinusitis
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 2 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
2/5 • Number of events 2 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Number of events 3 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 3 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Renal and urinary disorders
Chronic kidney disease
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 2 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Skin and subcutaneous tissue disorders
Scalp
|
20.0%
1/5 • Number of events 2 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Adverse events collected from date on treatment to 30 days after off treatment date, for an average of 9 months
No anticipated or unanticipated serious adverse events happened to participants on trial.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place