Trial Outcomes & Findings for Phase II FANG™ in Advanced Melanoma (NCT NCT01453361)
NCT ID: NCT01453361
Last Updated: 2018-05-24
Results Overview
To determine if subjects will have a positive (defined as \>10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until EOT (30 days after last dose).
TERMINATED
PHASE2
18 participants
Baseline, End of Treatment (30 days after last dose) up to 12 months
2018-05-24
Participant Flow
This study recruited patients with Stages IIIc and IV melanoma.
18 were enrolled but 10 screen-failed so only 8 proceeded with the single group assignment (Vigil treatment).
Participant milestones
| Measure |
Vigil™ Vaccine
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Vigil™ Vaccine
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
Overall Study
Disease Progression
|
6
|
|
Overall Study
Screen-Failures
|
10
|
Baseline Characteristics
Phase II FANG™ in Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Vigil™ Vaccine
n=18 Participants
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
Age, Customized
Age · 0-15 Years
|
0 Participants
n=99 Participants
|
|
Age, Customized
Age · 16-64 Years
|
9 Participants
n=99 Participants
|
|
Age, Customized
Age · 65 and Older Years
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (30 days after last dose) up to 12 monthsPopulation: 18 subjects were consented but only 8 subjects were administered Vigil treatment (10 screen-failed). 7 completed treatment (ELISPOT done) while 1 subject died soon after baseline (ELISPOT not done). After 12 months, 7 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.
To determine if subjects will have a positive (defined as \>10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until EOT (30 days after last dose).
Outcome measures
| Measure |
Vigil™ Vaccine
n=18 Participants
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
Not Done/Died immediately after Baseline
|
1 Participants
|
|
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
Not Done/Screen-Failed
|
10 Participants
|
|
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
ELISPOT Positive After 12 months
|
7 Participants
|
|
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
ELISPOT Negative After 12 months
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 18 subjects were consented but only 8 were administered Vigil treatment (10 screen-failed). These 8 subjects were followed for survival up to 3 years after Vigil treatment.
The survival status in patients with stages IIIc and IV melanoma treated with Vigil™ vaccine was determined by following these patients up to 3 years.
Outcome measures
| Measure |
Vigil™ Vaccine
n=18 Participants
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
Number of Alive Subjects
Alive Subjects After 3 years
|
1 Participants
|
|
Number of Alive Subjects
Dead Subjects After 3 years
|
7 Participants
|
|
Number of Alive Subjects
Screen-Failed
|
10 Participants
|
Adverse Events
Vigil™ Vaccine
Serious adverse events
| Measure |
Vigil™ Vaccine
n=18 participants at risk
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
Infections and infestations
Soft Tissue Infection
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
5.6%
1/18 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Hernia
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Vigil™ Vaccine
n=18 participants at risk
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Vigil™ Vaccine
|
|---|---|
|
General disorders
Injection Site Reaction
|
16.7%
3/18 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place