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Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin - (ATOMIC-Meso Phase 2/3 Study)

Studio Clinico

Patologia: Mesotelioma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: II Randomizzato, III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

1. Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor
2. Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
3. MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients) and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.
4. Measurable disease as assessed by modified RECIST for MPM for thoracic disease (Appendix A) and RECIST 1.1 for extra-thoracic disease (Appendix B).
5. ECOG performance status of 0 - 1 (Appendix C).
6. Predicted life expectancy of at least 12 weeks.

Criteri di esclusione: 

1. Radiotherapy (except for palliative reasons) the previous two weeks before.
2. Ongoing toxic manifestations of previous treatments.
3. Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
4. Major thoracic or abdominal surgery from which the patient has not yet recovered.
5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.
6. Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required

Trattamento sperimentale: 

ADI-PEG 20 plus Pem Cis

Trattamento di controllo: 

Placebo plus Pem Cis

Obiettivi primari dello studio: 

Response Rate [Time Frame: approximately 18 months]

Obiettivi secondari dello studio: 

Progression Free Survival [Time Frame: approximately 18 months]

Centri partecipanti

Nord Italia

SC Oncologia ASO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL

Riferimento: Dr.ssa Federica Grosso
Telefono: 0131206967


Cliniche Humanitas Gavazzeni
Via Gavazzeni 21 - 24125 Bergamo - BG


Azienda Sanitaria 3 genovese - Villa Scassi
Corso Scassi 1 - 16149 Genova-Sanpierdarena - GE


IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI


Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof. Filippo De Marinis
Telefono: 0257489773


A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB


Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR


IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV


Centro Italia

AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI

Informazioni Generali


Numero di iscrizione a registro: 2015-004281-28/NCT02709512

Data di inserimento: 29.10.2018

Data di aggiornamento: 09.10.2019


Polaris Group



Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Prof. Filippo De Marinis

Telefono: 0257489773


Localita: Milano


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