A Phase 2 interventional study of Vigil™ Vaccine and Bevacizumab in Stage III Ovarian Cancer and Stage IV Ovarian Cancer, sponsored by Gradalis, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Gradalis, Inc. · Phase 2, Interventional, and Treatment
This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Gradalis, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Normal organ and marrow function as defined below:
Exclusion Criteria:
Patients with clinically significant cardiovascular disease including any of the following:
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).
Biological: Vigil™ Vaccine · Drug: Bevacizumab
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).
Also known as: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine, formerly known as FANG™
Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.
Also known as: VEGF
Time to Progression
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.
Time frame: 24 months
Response Rate
Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
Time frame: Up to 12 months
Number of Alive Subjects
Survival status of patients after treatment was determined by following these patients up to 24 months.
Time frame: 24 months
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
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.
Time frame: Baseline, End of Treatment (30 days after last dose) up to 12 months
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).
| Milestone | Vigil™ Vaccine |
|---|---|
| Started | 5 |
| Completed | 2 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Disease progression | 2 |
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.
No measurements were reported for this outcome.
Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.
No measurements were reported for this outcome.
Survival status of patients after treatment was determined by following these patients up to 24 months.
| Participants | Vigil™ Vaccine |
|---|---|
| Alive Subjects After 24 months | 1 |
| Dead Subjects After 24 months | 4 |
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.
| Participants | Vigil™ Vaccine |
|---|---|
| ELISPOT-Positive After 12 months | 5 |
| ELISPOT-Negative After 12 months | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vigil™ Vaccine | 4/5 (80%) | 3/5 (60%) | 2/5 (40%) |
| Event | Vigil™ Vaccine |
|---|---|
| Acute CholecystitisHepatobiliary disorders | 1/5 |
| PharyngitisInfections and infestations | 1/5 |
| Intracerebral HemorrhageNervous system disorders | 1/5 |
| Event | Vigil™ Vaccine |
|---|---|
| Injection Site ReactionGeneral disorders | 2/5 |
| Age, Customized(Participants) | Vigil™ Vaccine |
|---|---|
| Age — 0-15 Years | 0 |
| Age — 16-64 Years | 3 |
| Age — 65 Years and Older | 2 |
| Sex: Female, Male(Participants) | Vigil™ Vaccine |
|---|---|
| Female | 5 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Vigil™ Vaccine |
|---|---|
| White/Caucasian | 5 |
| Black/African American | 0 |
| Asian | 0 |
| Hispanic | 0 |
| Other | 0 |
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Gradalis, Inc.