Phase 2
N=5
Salvage Ovarian FANG™ Vaccine + Bevacizumab
Stage III Ovarian Cancer · Stage IV Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01551745 ↗Enrolled (actual)
5
Serious AEs
60.0%
Results posted
May 2018
Primary outcome: Primary: Time to Progression
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vigil™ Vaccine (Biological); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gradalis, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
— | — |
| PRIMARY Response Rate |
— | — |
| SECONDARY Number of Alive Subjects |
1; 4 | — |
| SECONDARY Enzyme-Linked ImmunoSorbent Spot (ELISPOT) |
5; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed papillary serous or endometrioid ovarian cancer.
- 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.
- 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.
- Successful manufacturing of 4 vials of Vigil™ vaccine.
- Recovered from all clinically relevant toxicities related to prior therapies.
- ECOG PS 0-2 prior to Vigil™ vaccine administration.
- Normal organ and marrow function as defined below:
- Absolute granulocyte count ≥1,500/mm3
- Absolute lymphocyte count ≥ 200/mm3
- Platelets ≥100,000/mm3
- Total bilirubin ≤1.5 x ULN
- AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤2.5 x ULN
- Creatinine 0.24 sec or second or third degree AV block.
- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg.
- Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months.
- New York Heart Association grade II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication.
- Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit
- History of cerebrovascular accident within the past 6 months.
- No significant traumatic injury within the past 28 days.
- Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with known HIV.
- Patients with chronic Hepatitis B and C infection.
- Patients with uncontrolled autoimmune diseases.
Data sourced from ClinicalTrials.gov (NCT01551745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.