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A Trial of FANG™ Vaccine for Participants With Ovarian Cancer
Phase 2
Waitlist Available
Led By Minal Barve, MD
Research Sponsored by Gradalis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment start to the date of first recurrence or date of death if the participant died before recurrence. radiographic assessment at baseline, </= 1 week prior to cycle 4, at standard of care intervals, and when ca-125>35 u/ml, approximately 3 years.
Awards & highlights
No Placebo-Only Group
Summary
This trial tested Vigil, an immunotherapy made from a patient's own cancer cells, in women with advanced ovarian cancer who had surgery and completed chemotherapy. The goal was to see if Vigil could help prevent the cancer from coming back by boosting the immune system.
Eligible Conditions
- Ovarian Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment start to the date of first recurrence or date of death if the participant died before recurrence. radiographic assessment at baseline, </= 1 week prior to cycle 4, at standard of care intervals, and when ca-125>35 u/ml, approximately 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment start to the date of first recurrence or date of death if the participant died before recurrence. radiographic assessment at baseline, </= 1 week prior to cycle 4, at standard of care intervals, and when ca-125>35 u/ml, approximately 3 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Recurrence (TTR)
Secondary study objectives
Number of Participants Positive for T-cell and Immune Activation Markers
Predictive Potential of Tumor Infiltrating Lymphocyte (TIL) and Tumor Associated Macrophage (TAM) Phenotypes
Vigil Related Adverse Events (AEs)
Side effects data
From 2022 Phase 2 trial • 145 Patients • NCT0130923071%
Injection site reaction
29%
Fatigue
25%
Abdominal pain
18%
Diarrhea
14%
Back pain
14%
Urinary tract infection
14%
Constipation
11%
Sinus congestion
11%
Foot pain
11%
Myalgia
11%
Rash
11%
Arthralgia
11%
Cough
11%
Abdominal bloating
11%
Upper respiratory tract infection viral NOS
11%
Abdominal discomfort
11%
Upper respiratory infection
7%
Sinus infection
7%
Neck pain
7%
Erythematous rash
7%
Arthritis
7%
Dizziness
7%
Nasal congestion
7%
Leg cramps
7%
Edema extremities
7%
Seasonal allergy
7%
Pruritus
7%
Incision site tenderness
7%
Anemia
7%
Ear pain
7%
Nausea
7%
Epistaxis
7%
Hyperglycemia
4%
Tinnitus
4%
Cholelithiasis
4%
Thyroid nodule
4%
Peripheral sensory neuropathy
4%
Urethral burning on micturition
4%
Urination pain
4%
Papular rash
4%
Wheezing
4%
Biliary dilatation
4%
Headache
4%
Tympanic membrane disorder
4%
Madarosis
4%
Hirsutism
4%
Joint stiffness
4%
Edema
4%
Hypercalcemia
4%
INR increased
4%
Lethargy
4%
Groin discomfort
4%
Incision site pain
4%
Anxiety
4%
Dyspnea exertional
4%
Weakness
4%
Excoriation
4%
LDH increased
4%
Reticulocyte count increased
4%
Nasal dryness
4%
Vertigo
4%
Hyponatremia
4%
Contact dermatitis
4%
Leg pain
4%
Insomnia
4%
Rash papular
4%
Dry heaves
4%
Iron deficiency
4%
Weight gain
4%
Facial flushing
4%
Pelvic pain
4%
Peripheral neuropathy
4%
Numbness
4%
Depression
4%
Pain in extremity
4%
Oral thrush
4%
Erythema
4%
Subcutaneous nodule
4%
Weight loss
4%
Bloating
4%
Hot flashes
4%
Swollen ankles
4%
Spotting vaginal
4%
Toothache
4%
Hepatic steatosis
4%
Dry cough
4%
Opiate withdrawal symptoms
4%
Eczema
4%
Thrombocytopenia
4%
Lymphadenopathy cervical
4%
Canker sores oral
4%
Bronchitis viral
4%
Tympanic membrane scarring
4%
Astigmatism
4%
Night blindness
4%
Abdominal distension
4%
Abdominal tenderness
4%
Colonic diverticulosis
4%
Hernia abdominal wall
4%
Umbilical hernia
4%
Chest pain
4%
Hyperbilirubinemia
4%
Drug allergy
4%
Gastrointestinal viral infection
4%
Diverticulitis
4%
Otitis
4%
Pustules on hand
4%
Hypokalemia
4%
Rib pain
4%
Sensory neuropathy
4%
Taste alteration
4%
Irritability
4%
Kidney stone
4%
Itching
4%
Rosacea
4%
Hypertension
4%
Vomiting
4%
Creatinine increased
4%
Ear wax
4%
Ascites
4%
Stomach ache
4%
Sciatica
4%
Hidradenitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group A (Vigil™)
Group B (Observational - Standard of Care)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (Vigil™)Experimental Treatment1 Intervention
Vigil immunotherapy was administered at a concentration of at 1 x 10e7 cells/injection via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting ≥3 weeks following completion of chemotherapy (no longer than 2.5 months post chemotherapy). Participants were treated monthly for up to 12 months as long as sufficient Vigil was available and the participant was clinically stable.
Group II: Group B (Observational - Standard of Care)Active Control1 Intervention
Participants received standard of care without maintenance therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vigil™
2009
Completed Phase 2
~250
Find a Location
Who is running the clinical trial?
Gradalis, Inc.Lead Sponsor
15 Previous Clinical Trials
340 Total Patients Enrolled
4 Trials studying Ovarian Cancer
130 Patients Enrolled for Ovarian Cancer
Minal Barve, MDPrincipal InvestigatorInvestigator
11 Previous Clinical Trials
260 Total Patients Enrolled
2 Trials studying Ovarian Cancer
29 Patients Enrolled for Ovarian Cancer
John Nemunaitis, MDStudy DirectorGradalis, Inc.
11 Previous Clinical Trials
347 Total Patients Enrolled
4 Trials studying Ovarian Cancer
146 Patients Enrolled for Ovarian Cancer