Trial Outcomes & Findings for Salvage Ovarian FANG™ Vaccine + Carboplatinum (NCT NCT01867086)
NCT ID: NCT01867086
Last Updated: 2018-06-19
Results Overview
Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.
COMPLETED
PHASE2
1 participants
24 months
2018-06-19
Participant Flow
This study recruited subjects from CL-PTL-105 who recurred and were either randomized to the control/observation arm (Group B) or screen-failed but had successful manufacturing of Vigil (minimum of 4 doses).
1 subject was enrolled and administered Vigil plus Carboplatinum. This subject did not complete treatment due to disease progression.
Participant milestones
| Measure |
Vigil™ Vaccine
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Vigil™ Vaccine
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
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|---|---|
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Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Salvage Ovarian FANG™ Vaccine + Carboplatinum
Baseline characteristics by cohort
| Measure |
Vigil™ Vaccine
n=1 Participants
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.
Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.
Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, End of Treatment (30 days after last dose) up to 12 monthsPopulation: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 12 months, subject 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 30 days after last dose.
Outcome measures
| Measure |
Vigil™ Vaccine
n=1 Participants
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
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|---|---|
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Immune Analysis in Blood
ELISPOT-Positive After 12 months
|
1 Participants
|
|
Immune Analysis in Blood
ELISPOT-Negative After 12 months
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: 1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 24 months, subject was not alive. Statistical analysis was not done. This study was terminated.
Survival status of patients after treatment will be determined.
Outcome measures
| Measure |
Vigil™ Vaccine
n=1 Participants
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
Vigil™ Vaccine: Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
Carboplatinum: Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion)
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|---|---|
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Number of Alive Subjects
Alive Subjects After 24 months
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0 Participants
|
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Number of Alive Subjects
Dead Subjects After 24 months
|
1 Participants
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Adverse Events
Vigil™ Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vigil™ Vaccine
n=1 participants at risk
Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks.
|
|---|---|
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General disorders
Injection Site Reaction
|
0.00%
0/1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place