Trial Outcomes & Findings for Salvage Ovarian FANG™ Vaccine + Bevacizumab (NCT NCT01551745)

NCT ID: NCT01551745

Last Updated: 2021-10-19

Results Overview

Time to progression (TTP) following bevacizumab 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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2021-10-19

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).

5 subjects were enrolled and started Vigil treatment plus Bevacizumab. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1).

Participant milestones

Measure	Vigil™ Vaccine Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Vigil™ Vaccine Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Overall Study Withdrawal by Subject	1
Overall Study Disease Progression	2

Baseline Characteristics

Salvage Ovarian FANG™ Vaccine + Bevacizumab

Baseline characteristics by cohort

Measure	Vigil™ Vaccine n=5 Participants Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Age, Customized Age · 0-15 Years	0 Participants n=93 Participants
Age, Customized Age · 16-64 Years	3 Participants n=93 Participants
Age, Customized Age · 65 Years and Older	2 Participants n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race/Ethnicity, Customized White/Caucasian	5 Participants n=93 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=93 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=93 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). 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) following bevacizumab 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 months

Population: 5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). 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: 24 months

Population: 5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 24 months, only 1 of the 5 subjects was alive. Statistical analysis was not done. This study was terminated.

Survival status of patients after treatment was determined by following these patients up to 24 months.

Outcome measures

Measure	Vigil™ Vaccine n=5 Participants Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Number of Alive Subjects Alive Subjects After 24 months	1 Participants
Number of Alive Subjects Dead Subjects After 24 months	4 Participants

SECONDARY outcome

Timeframe: Baseline, End of Treatment (30 days after last dose) up to 12 months

Population: 5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 12 months, all 5 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 30 days after last dose.

Outcome measures

Measure	Vigil™ Vaccine n=5 Participants Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Enzyme-Linked ImmunoSorbent Spot (ELISPOT) ELISPOT-Positive After 12 months	5 Participants
Enzyme-Linked ImmunoSorbent Spot (ELISPOT) ELISPOT-Negative After 12 months	0 Participants

Adverse Events

Vigil™ Vaccine

Serious events: 3 serious events

Other events: 2 other events

Deaths: 4 deaths

Serious adverse events

Measure	Vigil™ Vaccine n=5 participants at risk Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Hepatobiliary disorders Acute Cholecystitis	20.0% 1/5 • Number of events 1
Infections and infestations Pharyngitis	20.0% 1/5 • Number of events 1
Nervous system disorders Intracerebral Hemorrhage	20.0% 1/5 • Number of events 1

Other adverse events

Measure

Vigil™ Vaccine n=5 participants at risk Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Vigil™ Vaccine: Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle). Bevacizumab: Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

General disorders Injection Site Reaction

40.0% 2/5 • Number of events 33

Additional Information

Director of Clinical Trials

Gradalis, Inc.

Phone: 2144428124

Email: info@gradalisinc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place