Efficacy of a Maintenance Treatment With TALAzoparib Following First Line Platinum-based Chemotherapy in Malignant MESOthelioma

Inclusion Criteria

• •Patients older than 18 years old
• •Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• •Histologically - or cytologically - confirmed malignant mesotheliomas: epithelioid, sarcomatoid, biphasic
• •Developed from pleura (cohort A) or from peritoneum (cohorts B1 and B2)
• •Previously treated with first-line platinum based-chemotherapy (including minimum one cycle of pemetrexed) for 4 to 6 cycles, with no sign of disease progression during chemotherapy.
• •No previous treatment with bevacizumab and PARP inhibitor
• •Minimum 6 weeks and maximum 8 weeks interval between last chemotherapy cycle and talazoparib start
• •For pleural mesotheliomas (cohort A), primary or interval debulking surgery with or without hyperthermic intrapleural or intrathoracic chemotherapy (HITHOC) will be authorized, in the case of non-complete cytoreductive surgery only
• •For peritoneal mesotheliomas
• •* In cohort B1, primary or interval debulking surgery ± hyperthermic intraperitoneal chemotherapy (HIPEC) will be authorized in the case of non-complete cytoreductive surgery (CC2 or CC3) only. This cohort will also include patients with non-operated diseases
• •* In cohort B2, complete macroscopic (CC0 or CC1) primary or interval debulking surgery ± HIPEC will be required.
• •Intraperitoneal treatment with pressurized intraperitoneal aerosol chemotherapy sessions (PIPAC) are not allowed.
• •Measurable or non-measurable (but radiologically evaluable) disease as per modified RECIST version 1.1 on computed tomography (CT) scan (within 28 days of talazoparib initiation)
• •Availability at the study site of a representative FFPE tumor sample in a block or at least 30 unstained slides from biopsy or surgery specimen, aged less than 6 months.
• •Patients with adequate bone marrow function measured within 28 days prior to administration of study treatment as defined below:
• •Absolute neutrophil count ≥1.0 x 109 /L
• •Platelet count ≥50 x 109 /L
• •Haemoglobin ≥8.0 g/dL (may have been blood transfused)
• •Patients with adequate renal function:
• •Calculated Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2 according to CKD-EPI formula
• •Patients with adequate hepatic function
• •Total bilirubin ≤ 1 × upper limit of normal \[ULN\] and aspartate aminotransferase (AST) \> ULN
• •Total bilirubin \> 1.0 to1.5 × ULN and any AST
• •Patients must have a life expectancy ≥16 week.
• •Confirmation of non-childbearing status (pregnancy test) for women of childbearing potential.
• •A highly effective method of contraception is required for female patients during treatment of talazoparib, and for at least 7 months after completing therapy. Advise male patients with female partners of reproductive potential and pregnant partners to use a condom, during treatment with talazoparib and for at least 4 months after the final dose.
• •Patients who gave its written informed consent to participate to the study.
• •Patients affiliated to a social insurance regime.
• •Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.