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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

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.

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

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 • NCT01309230

71%

Injection site reaction

29%

Fatigue

25%

Abdominal pain

18%

Diarrhea

14%

Back pain

14%

Constipation

14%

Urinary tract infection

11%

Sinus congestion

11%

Foot pain

11%

Myalgia

11%

Arthralgia

11%

Cough

11%

Abdominal bloating

11%

Abdominal discomfort

11%

Upper respiratory infection

11%

Upper respiratory tract infection viral NOS

11%

Rash

Neck pain

Incision site tenderness

Arthritis

Dizziness

Erythematous rash

Nasal congestion

Leg cramps

Seasonal allergy

Pruritus

Anemia

Ear pain

Nausea

Edema extremities

Epistaxis

Sinus infection

Hyperglycemia

Peripheral sensory neuropathy

Biliary dilatation

Edema

Tinnitus

Spotting vaginal

Joint stiffness

INR increased

Lethargy

Groin discomfort

Wheezing

Weakness

Excoriation

LDH increased

Reticulocyte count increased

Nasal dryness

Vertigo

Hyponatremia

Contact dermatitis

Leg pain

Insomnia

Madarosis

Rash papular

Dry heaves

Iron deficiency

Weight gain

Facial flushing

Peripheral neuropathy

Numbness

Depression

Pain in extremity

Weight loss

Hot flashes

Hepatic steatosis

Dry cough

Opiate withdrawal symptoms

Dyspnea exertional

Eczema

Thrombocytopenia

Toothache

Lymphadenopathy cervical

Thyroid nodule

Canker sores oral

Bronchitis viral

Bloating

Tympanic membrane disorder

Pelvic pain

Tympanic membrane scarring

Astigmatism

Night blindness

Abdominal distension

Abdominal tenderness

Colonic diverticulosis

Hernia abdominal wall

Stomach ache

Umbilical hernia

Chest pain

Cholelithiasis

Hyperbilirubinemia

Drug allergy

Gastrointestinal viral infection

Diverticulitis

Otitis

Pustules on hand

Incision site pain

Hypercalcemia

Swollen ankles

Hypokalemia

Erythema

Rib pain

Sciatica

Urethral burning on micturition

Anxiety

Sensory neuropathy

Taste alteration

Irritability

Urination pain

Kidney stone

Papular rash

Subcutaneous nodule

Hidradenitis

Hirsutism

Itching

Rosacea

Hypertension

Headache

Vomiting

Creatinine increased

Oral thrush

Ear wax

Ascites

100%

80%

60%

40%

20%

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

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