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CompletedNCT01551745Updated Oct 19, 2021Results posted

Salvage Ovarian FANG™ Vaccine + Bevacizumab

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

Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer

Keywords

  • Papillary Serous Ovarian Cancer
  • Endometrioid Ovarian Cancer
  • Epithelial Ovarian Cancer
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In context

Ovarian Neoplasms

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed papillary serous or endometrioid ovarian cancer.
  2. Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or patients with vaccine prepared for CLPTL 105 but not otherwise qualifying.
  3. Recurrent cisplatinum resistant/refractory disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements with no intervening therapy.
  4. Successful manufacturing of 4 vials of Vigil™ vaccine.
  5. Recovered from all clinically relevant toxicities related to prior therapies.
  6. ECOG PS 0-2 prior to Vigil™ vaccine administration.
  7. Normal organ and marrow function as defined below:

    1. Absolute granulocyte count ≥1,500/mm3
    2. Absolute lymphocyte count ≥ 200/mm3
    3. Platelets ≥100,000/mm3
    4. Total bilirubin ≤1.5 x ULN
    5. AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤2.5 x ULN
    6. Creatinine \<1.5 mg/dL
    7. INR \< 1.5
  8. Baseline blood pressure must be under 140/90
  9. Urine protein-to-creatinine ratio \< 1.0 mg/dL.
  10. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
  11. Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion criteria

Exclusion Criteria:

  1. Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.
  2. Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab.
  3. Patient must not have received any other investigational agents within 4 weeks prior to study entry.
  4. Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
  5. Patients with history of brain metastases.
  6. Patients with compromised pulmonary disease.
  7. Short term (\<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
  8. Prior splenectomy.
  9. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
  10. Kaposi's Sarcoma.
  11. Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels.
  12. History of Stroke/Transient Ischemic Attack
  13. Use of bleeding diathesis
  14. Use of anti-coagulants
  15. Patients with clinically significant cardiovascular disease including any of the following:

    1. Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or second or third degree AV block.
    2. Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg.
    3. Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months.
    4. New York Heart Association grade II or greater congestive heart failure.
    5. Serious cardiac arrhythmia requiring medication.
    6. Grade II or greater peripheral vascular disease except episodes of ischemia \< 24 hours induration that are managed non-surgically and without permanent deficit
    7. History of cerebrovascular accident within the past 6 months.
    8. No significant traumatic injury within the past 28 days.
  16. Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
  17. Patients with known HIV.
  18. Patients with chronic Hepatitis B and C infection.
  19. Patients with uncontrolled autoimmune diseases.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    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).

    Biological: Vigil™ Vaccine · Drug: Bevacizumab

Interventions

  • BiologicalVigil™ 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).

    Also known as: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine, formerly known as FANG™

  • DrugBevacizumab

    Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

    Also known as: VEGF

06

What researchers measure

Primary outcomes

  1. 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

  2. Response Rate

    Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

    Time frame: Up to 12 months

Secondary outcomes

  1. Number of Alive Subjects

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

    Time frame: 24 months

  2. 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

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Results

Posted May 1, 2018

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).

Participant flow — Overall Study
MilestoneVigil™ Vaccine
Started5
Completed2
Not completed3
Withdrew: Withdrawal by subject1
Withdrew: Disease progression2

Outcome measures

PrimaryTime 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

No measurements were reported for this outcome.

PrimaryResponse Rate

Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

Time frame:
Up to 12 months

No measurements were reported for this outcome.

SecondaryNumber of Alive Subjects

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

Time frame:
24 months
Reported as:
Count of participants · Participants
Number of Alive Subjects
ParticipantsVigil™ Vaccine
Alive Subjects After 24 months1
Dead Subjects After 24 months4
SecondaryEnzyme-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
Reported as:
Count of participants · Participants
Enzyme-Linked ImmunoSorbent Spot (ELISPOT)
ParticipantsVigil™ Vaccine
ELISPOT-Positive After 12 months5
ELISPOT-Negative After 12 months0

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vigil™ Vaccine4/5 (80%)3/5 (60%)2/5 (40%)
Most frequent serious events
Most frequent serious events
EventVigil™ Vaccine
Acute CholecystitisHepatobiliary disorders1/5
PharyngitisInfections and infestations1/5
Intracerebral HemorrhageNervous system disorders1/5
Most frequent other events
Most frequent other events
EventVigil™ Vaccine
Injection Site ReactionGeneral disorders2/5

Baseline characteristics

Age, Customized
Age, Customized(Participants)Vigil™ Vaccine
Age — 0-15 Years0
Age — 16-64 Years3
Age — 65 Years and Older2
Sex: Female, Male
Sex: Female, Male(Participants)Vigil™ Vaccine
Female5
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Vigil™ Vaccine
White/Caucasian5
Black/African American0
Asian0
Hispanic0
Other0
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Study locations

1 site
  • Mary Crowley Cancer Research Centers
    Dallas, Texas 75230, United States
09

References and documents

Publications

  • Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20. PubMed 22186789 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01551745
Lead sponsor
Gradalis, Inc.
Responsible party
Sponsor
First posted
Mar 13, 2012
Start date
Mar 2012
Primary completion
Apr 2016
Completion
Apr 2016
Results posted
May 1, 2018
Last update
Oct 19, 2021

Study contacts

Minal Barve, MD
principal investigator · Mary Crowley Cancer Research Centers

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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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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