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Enzyme

Drug: ADI-PEG 20 plus Pem Platinum for Mesothelioma (ATOMIC Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Polaris Group
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 18 months

Summary

This trial is testing ADI-PEG 20, an enzyme that breaks down arginine, in patients with malignant pleural mesothelioma. The goal is to starve the cancer cells by removing a nutrient they need to grow. ADI-PEG20 has been studied for various cancers.

Eligible Conditions
  • Mesothelioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Overall Survival Phase 3 Interim Analysis
Response Rate
Secondary study objectives
Progression Free Survival

Side effects data

From 2022 Phase 2 & 3 trial • 249 Patients • NCT02709512
53%
Fatigue
52%
Nausea
43%
Constipation
27%
Anemia
21%
Decreased Appetite
5%
Dyspnoea
5%
Acute Kidney Injury
4%
Pneumonia
4%
Pyrexia
3%
Atrial Fibrillation
2%
Anaphylactic Reaction
2%
Fall
1%
Sepsis
1%
Musculoskeletal Testing
1%
Cerebrovascular Accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Drug: Placebo Plus Pem Platinum
Drug: ADI-PEG 20 Plus Pem Platinum

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: ADI-PEG 20 plus Pem PlatinumExperimental Treatment1 Intervention
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication
Group II: Drug: Placebo plus Pem PlatinumPlacebo Group1 Intervention
Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADI-PEG 20 plus Pem Platinum
2017
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Polaris GroupLead Sponsor
24 Previous Clinical Trials
3,112 Total Patients Enrolled
1 Trials studying Mesothelioma
85 Patients Enrolled for Mesothelioma
John S Bomalaski, MDStudy DirectorPolaris Group
1 Previous Clinical Trials
60 Total Patients Enrolled
~30 spots leftby Nov 2025
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