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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
Study Summary
This trial is testing an autologous tumor cell vaccine called Vigil™ given monthly for up to 12 doses as maintenance therapy for ovarian cancer. Tumor will be harvested at the time of surgical debulking and patients will be stratified for surgical stage and post-op chemotherapy.
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
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 • NCT0130923071%
Injection site reaction
29%
Fatigue
25%
Abdominal pain
18%
Diarrhea
14%
Constipation
14%
Urinary tract infection
14%
Back pain
11%
Abdominal bloating
11%
Sinus congestion
11%
Abdominal discomfort
11%
Upper respiratory infection
11%
Upper respiratory tract infection viral NOS
11%
Arthralgia
11%
Foot pain
11%
Myalgia
11%
Cough
11%
Rash
7%
Sinus infection
7%
Dizziness
7%
Epistaxis
7%
Nasal congestion
7%
Anemia
7%
Ear pain
7%
Nausea
7%
Edema extremities
7%
Seasonal allergy
7%
Incision site tenderness
7%
Hyperglycemia
7%
Arthritis
7%
Leg cramps
7%
Neck pain
7%
Erythematous rash
7%
Pruritus
4%
Sciatica
4%
Wheezing
4%
Tympanic membrane scarring
4%
Vertigo
4%
Abdominal tenderness
4%
Peripheral neuropathy
4%
Thyroid nodule
4%
Hidradenitis
4%
Bloating
4%
Headache
4%
Lethargy
4%
Hirsutism
4%
Nasal dryness
4%
Tinnitus
4%
Tympanic membrane disorder
4%
Ascites
4%
Itching
4%
Night blindness
4%
Peripheral sensory neuropathy
4%
Numbness
4%
Opiate withdrawal symptoms
4%
Dry cough
4%
Bronchitis viral
4%
Lymphadenopathy cervical
4%
Thrombocytopenia
4%
Ear wax
4%
Astigmatism
4%
Abdominal distension
4%
Canker sores oral
4%
Colonic diverticulosis
4%
Dry heaves
4%
Hernia abdominal wall
4%
Stomach ache
4%
Toothache
4%
Umbilical hernia
4%
Vomiting
4%
Chest pain
4%
Edema
4%
Weakness
4%
Biliary dilatation
4%
Cholelithiasis
4%
Hepatic steatosis
4%
Hyperbilirubinemia
4%
Drug allergy
4%
Diverticulitis
4%
Gastrointestinal viral infection
4%
Oral thrush
4%
Otitis
4%
Pustules on hand
4%
Excoriation
4%
Incision site pain
4%
Creatinine increased
4%
INR increased
4%
LDH increased
4%
Reticulocyte count increased
4%
Weight gain
4%
Weight loss
4%
Hypercalcemia
4%
Hypokalemia
4%
Hyponatremia
4%
Iron deficiency
4%
Groin discomfort
4%
Joint stiffness
4%
Leg pain
4%
Pain in extremity
4%
Rib pain
4%
Swollen ankles
4%
Sensory neuropathy
4%
Taste alteration
4%
Anxiety
4%
Depression
4%
Insomnia
4%
Irritability
4%
Kidney stone
4%
Urethral burning on micturition
4%
Urination pain
4%
Pelvic pain
4%
Spotting vaginal
4%
Dyspnea exertional
4%
Contact dermatitis
4%
Eczema
4%
Erythema
4%
Madarosis
4%
Papular rash
4%
Rash papular
4%
Rosacea
4%
Subcutaneous nodule
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
John Nemunaitis, MDStudy DirectorGradalis, Inc.
11 Previous Clinical Trials
347 Total Patients Enrolled
4 Trials studying Ovarian Cancer
146 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is Vigil™ a reliable option for individuals?
"Certified clinical data has been collected to verify some level of safety, so Vigil™ received a score of 2. However, efficacy is yet to be confirmed in any studies."
Answered by AI
How widely-distributed is the trial for this research endeavor within this state?
"This research endeavour is inviting patients to join from Texas Oncology - Sammons Cancer Center in Dallas, Washington, Cancer Care Northwest in Spokane, Florida, Mary Crowley Cancer Research Centers in West Palm Beach and 6 other centres."
Answered by AI
Is this clinical trial still accepting new participants?
"Clinialtrials.gov has reported that this trial, which was initially posted on February 1st 2011, is no longer accepting candidates as of February 9th 2022. Nonetheless, 677 other studies are actively recruiting participants at present."
Answered by AI
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