MesotheliomaPhase 2/3ATOMICNCT02709512
Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
A Phase 2/3 study testing ADI-PEG 20 plus Pem Platinum in people with Mesothelioma, run by Polaris Group at 45 sites in 5 countries.
Trial summary
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- ADI-PEG 20 plus Pem Platinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 45 sitesin 5 countries
- Study dates
- 1 Aug 2017to 15 Aug 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven unresectable MPM of biphasic or sarcomatoid histology
- Naïve to chemotherapy or immunotherapy
- ECOG PS 0-1
- Expected survival of at least 3 months
- Age 18 years or over (there is no upper age limit)
- Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
- Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
- Adequate hematologic, hepatic, and renal function
Who cannot join
- Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
- History of unstable cardiac disease
- Ongoing toxic manifestations of previous treatments
- Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
Trial locations and contacts
45 sites in 5 countries.
45 sites in 5 countries
United Kingdom14 sites
Wansbeck General Hospital
Ashington, Northumberland, NE63 9JJ
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB20QQ
Velindre Cancer Centre
Cardiff, CF14 2TL
Edinburgh Cancer Centre
Edinburgh, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
St James's University Hospital
Leeds, LS9 7TF
University Hospitals Leicester
Leicester, Leicestershire, LE1 5WW
Centre for Experimental Cancer Medicine (CECM)
London, England, EC1M 6BQ
St Bartholomew's Hospital
London, EC1A 7BE
University Hospital of South Manchester
Manchester, M23 9LT
Oxford Cancer and Haematology Centre, The Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
Plymouth Hospitals (Derriford Hospital)
Plymouth, Devon, PL6 8DH
Scunthorpe General Hospital
Scunthorpe, North Lincolnshire, DN15 7BH
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
United States10 sites
University of Maryland, Marlene & Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
University of Chicago
Chicago, Illinois, 60637
Henry Ford Hospital
Detroit, Michigan, 48202
MD Anderson Cancer Center
Houston, Texas, 77030
UCLA Hematology & Oncology - Santa Monica
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco Helen Diller Comprehensive Cancer Center
San Francisco, California, 94115
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Italy9 sites
SS. Antonio e Biagio e Cesare Arrigo Hospital
Alessandria, AL, 15121
Humanitas Gavazzeni
Bergamo, BG, 24125
Ospedale Villa Scassi
Genova, GE, 16149
European Institute of Oncology
Milan, MI, 20141
Fondazione IRCCS - Istituto Nazionale dei Tumori Milano
Milan, 20133
Azienda Ospedaliera San Gerardo - Monza, Chirurgia Toracica
Monza, MB, 20900
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124
Australia6 sites
Southern Adelaide Local Health Network, Inc.
Bedford Park, South Australia, 5042
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Austin Health
Heidelberg, Victoria, 3084
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Tweed Hospital (NNSW LHD)
Tweed Heads, New South Wales, 2486
Princess Alexandria Hospital and Health Services
Woolloongabba, Queensland, 4102
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang Gung Medical Foundation Kaohsiung
Kaohsiung City, 83301
Taichung Veterans General Hospital
Taichung, 407
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 112
Chang Gung Memorial Foundation LinKou Branch
Taoyuan, 33305
About this study
Official title: Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
- Conditions
- Mesothelioma
- Being tested
- ADI-PEG 20 plus Pem Platinum, Placebo plus Pem Platinum
- Keywords
- Malignant Pleural Mesothelioma
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADI-PEG 20 plus Pem PlatinumDrug
Also called Pemetrexed, Cisplatin, Carboplatin
Investigational Drug in combination approved standard of care treatment for this indication
Placebo plus Pem PlatinumOther
Also called Pemetrexed, Cisplatin, Carboplatin
Placebo in combination approved standard of care treatment for this indication
| Study group | Role | What they receive |
|---|---|---|
| Drug: ADI-PEG 20 plus Pem Platinum | Experimental | 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 Receives: Drug: ADI-PEG 20 plus Pem Platinum |
| Drug: Placebo plus Pem Platinum | Placebo comparator | 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 Receives: Other: Placebo plus Pem Platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation.
To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid).
Measured: approximately 18 months
Overall Survival Phase 3 Interim Analysis
The primary analysis of OS Phase 3 was performed at the interim analysis. This was performed once 50% of the planned OS events for phase 3 have occurred (ie, 169 of the 338 planned OS events). This interim analysis will evaluate OS in the ITT population in an unblinded manner. The OS data at the second interim analysis will be analyzed to support the following decisions:
Futility stopping: Terminate the study due to futility at the interim analysis. Sample size re-estimation: Increase the target number of OS events after the second interim analysis.. The treatment effect on OS will be evaluated using the stratified log-rank test (stratified by tumor histology).
Measured: Approximately 18 months
Overall Survival
Overall survival is defined as the time from randomization until death. In the event that no death was documented prior to study termination or analysis cutoff, OS was censored at the last known date the subject was known to be alive, either through completion of on-study visits or through survival follow-up contact.
The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology).
The Kaplan-Meier curves were also plotted. A Cox proportional hazard model with an adjustment for tumor histology (biphasic vs sarcomatoid) was used to compute the estimated hazard ratio and two-sided 95% CI. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The significance level to be used in the OS analysis at the final analysis was based on α = 0.04999 (two-sided).
Measured: 18 months
Secondary outcomes (1)
Progression Free Survival
The key secondary endpoint for the phase 3 portion is PFS, which will be analyzed only if the analysis of OS is statistically significant at the final analysis, with alpha level of 0.05 (two-sided) using the same statistical methodologies as applied to OS.
Measured: approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start1 Aug 2017
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polaris Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John S Bomalaski, MD, Study director, Polaris Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709512
- Sponsor's protocol ID
- POLARIS2015-003
- Acronym
- ATOMIC
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2016
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Szlosarek PW, Creelan BC, Sarkodie T, Nolan L, Taylor P, Olevsky O, Grosso F, Cortinovis D, Chitnis M, Roy A, Gilligan D, Kindler H, Papadatos-Pastos D, Ceresoli GL, Mansfield AS, Tsao A, O'Byrne KJ, Nowak AK, Steele J, Sheaff M, Shiu CF, Kuo CL, Johnston A, Bomalaski J, Zauderer MG, Fennell DA; ATOMIC-Meso Study Group. Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural Mesothelioma: The ATOMIC-Meso Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):475-483. doi: 10.1001/jamaoncol.2023.6789.
PubMed 38358753Szlosarek PW, Phillips MM, Pavlyk I, Steele J, Shamash J, Spicer J, Kumar S, Pacey S, Feng X, Johnston A, Bomalaski J, Moir G, Lau K, Ellis S, Sheaff M. Expansion Phase 1 Study of Pegargiminase Plus Pemetrexed and Cisplatin in Patients With Argininosuccinate Synthetase 1-Deficient Mesothelioma: Safety, Efficacy, and Resistance Mechanisms. JTO Clin Res Rep. 2020 Sep 3;1(4):100093. doi: 10.1016/j.jtocrr.2020.100093. eCollection 2020 Nov.
PubMed 34589965Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2. No abstract available.
PubMed 33358660
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
- ClinicalTrials.gov ID
- NCT02709512
- Acronym / sponsor ID
- ATOMIC / POLARIS2015-003
- Conditions
- Mesothelioma
- Keywords
- Malignant Pleural Mesothelioma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Polaris GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: ADI-PEG 20 plus Pem Platinum | Experimental | Drug: ADI-PEG 20 plus Pem PlatinumDose: 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 |
| Drug: Placebo plus Pem Platinum | Placebo comparator | Other: Placebo plus Pem PlatinumDose: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven unresectable MPM of biphasic or sarcomatoid histology
- Naïve to chemotherapy or immunotherapy
- ECOG PS 0-1
- Expected survival of at least 3 months
- Age 18 years or over (there is no upper age limit)
Key exclusion criteria (5 listed)
- Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
- History of unstable cardiac disease
- Ongoing toxic manifestations of previous treatments
- Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADI-PEG 20 plus Pem PlatinumAlso: Pemetrexed, Cisplatin, CarboplatinInvestigational Drug in combination approved standard of care treatment for this indication | Drug | Drug: ADI-PEG 20 plus Pem Platinum |
| Placebo plus Pem PlatinumAlso: Pemetrexed, Cisplatin, CarboplatinPlacebo in combination approved standard of care treatment for this indication | Other | Drug: Placebo plus Pem Platinum |
Primary outcome
Response Rate
Time frame: approximately 18 months
Objective Response Rate is calculated as the proportion of subjects whose best tumor response from all post-baseline tumor assessments is complete response (CR) or partial response (PR). The best tumor response is the best response recorded from the start of the treatment until the end of treatment taking into account any requirement for confirmation. To test Objective Response Rate significance, a Relative Risk Ratio (ADI-PEG 20 / Placebo) was calculated as the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology (biphasic versus sarcomatoid).
Overall Survival Phase 3 Interim Analysis
Time frame: Approximately 18 months
The primary analysis of OS Phase 3 was performed at the interim analysis. This was performed once 50% of the planned OS events for phase 3 have occurred (ie, 169 of the 338 planned OS events). This interim analysis will evaluate OS in the ITT population in an unblinded manner. The OS data at the second interim analysis will be analyzed to support the following decisions: Futility stopping: Terminate the study due to futility at the interim analysis. Sample size re-estimation: Increase the target number of OS events after the second interim analysis.. The treatment effect on OS will be evaluated using the stratified log-rank test (stratified by tumor histology).
Overall Survival
Time frame: 18 months
Overall survival is defined as the time from randomization until death. In the event that no death was documented prior to study termination or analysis cutoff, OS was censored at the last known date the subject was known to be alive, either through completion of on-study visits or through survival follow-up contact. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The Kaplan-Meier curves were also plotted. A Cox proportional hazard model with an adjustment for tumor histology (biphasic vs sarcomatoid) was used to compute the estimated hazard ratio and two-sided 95% CI. The treatment effect on OS was evaluated using the stratified log-rank test (stratified by tumor histology). The significance level to be used in the OS analysis at the final analysis was based on α = 0.04999 (two-sided).
1 secondary outcome
Progression Free Survival
Time frame: approximately 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38358753Szlosarek PW, Creelan BC, Sarkodie T, Nolan L, Taylor P, Olevsky O, Grosso F, Cortinovis D, Chitnis M, Roy A, Gilligan D, Kindler H, Papadatos-Pastos D, Ceresoli GL, Mansfield AS, Tsao A, O'Byrne KJ, Nowak AK, Steele J, Sheaff M, Shiu CF, Kuo CL, Johnston A, Bomalaski J, Zauderer MG, Fennell DA; ATOMIC-Meso Study Group. Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural Mesothelioma: The ATOMIC-Meso Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):475-483. doi: 10.1001/jamaoncol.2023.6789.
- Derived from this study: PubMed 34589965Szlosarek PW, Phillips MM, Pavlyk I, Steele J, Shamash J, Spicer J, Kumar S, Pacey S, Feng X, Johnston A, Bomalaski J, Moir G, Lau K, Ellis S, Sheaff M. Expansion Phase 1 Study of Pegargiminase Plus Pemetrexed and Cisplatin in Patients With Argininosuccinate Synthetase 1-Deficient Mesothelioma: Safety, Efficacy, and Resistance Mechanisms. JTO Clin Res Rep. 2020 Sep 3;1(4):100093. doi: 10.1016/j.jtocrr.2020.100093. eCollection 2020 Nov.
- Derived from this study: PubMed 33358660Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Bomalaski, MD study director
Polaris Group
45 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ADI-PEG 20 plus Pem Platinum in people with Mesothelioma, run by Polaris Group at 45 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United Kingdom, United States, Italy, Australia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: approximately 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709512, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.