Clinical trial NCT02709512: Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mesothelioma
Keywords: Malignant Pleural Mesothelioma
Lead sponsor: Polaris Group
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Response Rate
timeFrame: approximately 18 months
measure: Overall Survival Phase 3 Interim Analysis
timeFrame: Approximately 18 months
measure: Overall Survival
timeFrame: 18 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: approximately 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology & Oncology - Santa Monica
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Helen Diller Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Marlene & Stewart Greenebaum Comprehensive Cancer Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Tweed Heads
country: Australia
facility: Tweed Hospital (NNSW LHD)
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandria Hospital and Health Services
state: Queensland
city: Bedford Park
country: Australia
facility: Southern Adelaide Local Health Network, Inc.
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Alessandria
country: Italy
facility: SS. Antonio e Biagio e Cesare Arrigo Hospital
state: AL
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
state: BG
city: Genova
country: Italy
facility: Ospedale Villa Scassi
state: GE
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo - Monza, Chirurgia Toracica
state: MB
city: Milano
country: Italy
facility: European Institute of Oncology
state: MI
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: PV
city: Milan
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale dei Tumori Milano
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Foundation LinKou Branch
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals (Derriford Hospital)
state: Devon
city: London
country: United Kingdom
facility: Centre for Experimental Cancer Medicine (CECM)
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
state: Leicestershire
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
state: North Lincolnshire
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
state: Northumberland
city: Oxford
country: United Kingdom
facility: Oxford Cancer and Haematology Centre, The Churchill Hospital
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
Study officials:
affiliation: Polaris Group
name: John S Bomalaski, MD
role: STUDY_DIRECTOR
References:
citation: Szlosarek 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.
citation: Uprety 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.