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Vigil™ for 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

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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Recurrence (TTR)
Secondary outcome measures
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 • NCT01309230
71%
Injection site reaction
29%
Fatigue
25%
Abdominal pain
18%
Diarrhea
14%
Constipation
14%
Urinary tract infection
14%
Back pain
11%
Sinus congestion
11%
Rash
11%
Myalgia
11%
Upper respiratory infection
11%
Upper respiratory tract infection viral NOS
11%
Arthralgia
11%
Cough
11%
Abdominal bloating
11%
Abdominal discomfort
11%
Foot pain
7%
Sinus infection
7%
Hyperglycemia
7%
Erythematous rash
7%
Pruritus
7%
Nausea
7%
Incision site tenderness
7%
Dizziness
7%
Ear pain
7%
Edema extremities
7%
Seasonal allergy
7%
Arthritis
7%
Neck pain
7%
Anemia
7%
Leg cramps
7%
Epistaxis
7%
Nasal congestion
4%
Bloating
4%
Toothache
4%
Vomiting
4%
Weakness
4%
Hyperbilirubinemia
4%
Diverticulitis
4%
Gastrointestinal viral infection
4%
Oral thrush
4%
Otitis
4%
Pustules on hand
4%
Weight loss
4%
Lethargy
4%
Numbness
4%
Peripheral neuropathy
4%
Sciatica
4%
Sensory neuropathy
4%
Depression
4%
Insomnia
4%
Spotting vaginal
4%
Nasal dryness
4%
Wheezing
4%
Erythema
4%
Hidradenitis
4%
Hirsutism
4%
Itching
4%
Madarosis
4%
Rash papular
4%
Subcutaneous nodule
4%
Hyponatremia
4%
Iron deficiency
4%
Pain in extremity
4%
Peripheral sensory neuropathy
4%
Papular rash
4%
Astigmatism
4%
Taste alteration
4%
Anxiety
4%
Bronchitis viral
4%
Hypercalcemia
4%
Hypokalemia
4%
Headache
4%
Canker sores oral
4%
Colonic diverticulosis
4%
Opiate withdrawal symptoms
4%
Vertigo
4%
Tinnitus
4%
Chest pain
4%
Tympanic membrane scarring
4%
Ear wax
4%
Thyroid nodule
4%
Tympanic membrane disorder
4%
Abdominal distension
4%
Abdominal tenderness
4%
Ascites
4%
Hernia abdominal wall
4%
Edema
4%
Drug allergy
4%
Stomach ache
4%
Umbilical hernia
4%
Hepatic steatosis
4%
Joint stiffness
4%
Leg pain
4%
Swollen ankles
4%
Dry cough
4%
Dyspnea exertional
4%
Lymphadenopathy cervical
4%
Thrombocytopenia
4%
Night blindness
4%
Dry heaves
4%
Biliary dilatation
4%
Cholelithiasis
4%
Excoriation
4%
Incision site pain
4%
Creatinine increased
4%
INR increased
4%
LDH increased
4%
Reticulocyte count increased
4%
Weight gain
4%
Groin discomfort
4%
Rib pain
4%
Irritability
4%
Kidney stone
4%
Urethral burning on micturition
4%
Urination pain
4%
Pelvic pain
4%
Contact dermatitis
4%
Eczema
4%
Rosacea
4%
Facial flushing
4%
Hot flashes
4%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group A (Vigil™)
Group B (Observational - Standard of Care)

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
~10 spots leftby Sep 2025
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