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PD-L1 Inhibitor
Atezolizumab for Ovarian Cancer
Phase 2
Waitlist Available
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 from baseline (prior to treatment) up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for ovarian cancer.
Eligible Conditions
- Gynecological Cancers
- Ovarian Cancer
- Cervical Cancer
- Uterine Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (prior to treatment) up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (prior to treatment) up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Treatment-emergent AEs of Vigil + Atezolizumab
Secondary outcome measures
Immune Response Rate
Overall Survival (OS)
Radiographic Overall Response Rate (ORR)
+1 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 3: Atezo OnlyExperimental Treatment1 Intervention
Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days
Group II: Part 2: Vigil first then combination Vigil + AtezoExperimental Treatment2 Interventions
After Part 1 participants completed completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence (Vigil administered first, followed 30 minutes later by atezolizumab)
Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 107 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil
1 cycle = 21 days
Group III: Part 2: Atezo first then combination of Vigil + AtezoExperimental Treatment2 Interventions
After Part 1 participants completed completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence (Vigil administered first, followed 30 minutes later by atezolizumab).
Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 107 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. 1 cycle = 21 days
Group IV: Part 1: Vigil + AtezoExperimental Treatment2 Interventions
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vigil
2016
Completed Phase 3
~250
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Gradalis, Inc.Lead Sponsor
15 Previous Clinical Trials
460 Total Patients Enrolled
4 Trials studying Ovarian Cancer
250 Patients Enrolled for Ovarian Cancer
Roche-GenentechIndustry Sponsor
24 Previous Clinical Trials
3,660 Total Patients Enrolled
Luisa Manning, MDStudy DirectorGradalis, Inc.
7 Previous Clinical Trials
155 Total Patients Enrolled
2 Trials studying Ovarian Cancer
92 Patients Enrolled for Ovarian Cancer
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