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Title

Niraparib Efficacy in patients with unResectable MesotheliOma: A randomised phase II trial of Niraparib versus active symptom control in patients with previously treated mesothelioma

Description

Personalised therapy for mesothelioma is lacking. Based on published single agent activity, inhibition of Poly-ADP ribose polymerase is a promising treatment strategy warranting further study. Accordingly, NERO is a randomised phase II study designed to evaluate the efficacy of PARP inhibition in mesothelioma.

Mesothelioma patients with any histological subtype (epithelioid or non-epithelioid) and any site (pleural or peritoneal) who have previously received approved systemic therapy containing platinum will be randomised between Active Symptom Control (ASC)+Niraparib and ASC. Patients will be randomised in a 2:1 ratio to the Niraparib arm. Randomisation will be stratified by histology and best response to platinum therapy. NERO aims to recruit 84 patients (56 in the intervention arm and 28 in the control arm) from approximately 10 UK sites.

Objectives

Primary:

• To determine the efficacy of Active symptom control+ Niraparib versus active symptom control (ASC) in patients who have relapsed after previously receiving platinum based systemic therapy.

Secondary:

To determine whether Niraparib (over ASC)

• Increases overall survival
• Improves best objective response ORR
• Improves 12 and 24 week Disease Control Rate (DCR)
• Exhibits durable response
• Has good safety/tolerability
• Shows compliance to treatment

Translational:

• To correlate homologous recombination gene alterations and clinical outcome.
• To identify causes of acquired resistance to Niraparib in a subset of patients undergoing optional re-biopsy at disease progression.

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Trial Design

A multicentre, two arm, open-label UK randomised phase II trial in patients with mesothelioma of any histological subtype and any site who have previously received an approved systemic therapy containing platinum.

Trial Status

Closed to recruitment / In follow-up

Population

Mesothelioma patients with any histological subtype (epithelioid or non-epithelioid) and any site (pleural or peritoneal mesothelioma) who have previously received an approved systemic therapy containing pemetrexed-platinum. NERO is not restricted by line of therapy.

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This trial is funded by Asthma and Lung UK, with additional support from Cancer Research UK