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The University of Southampton
Southampton Clinical Trials Unit

NERO

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).

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.

 

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

Open to recruitment

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.

 

 

British LUng Foundation logo

This trial is funded by the British Lung Foundation, with additional support from Cancer Research UK

Senior Trial Manager:

Zina Eminton

Trial Manager:

Daniel Griffiths

Trial Coordinator:

Abigail Morgan-Fox

Data Manager:

Lucy Johnson

 

Contact Information for trial queries

Email: NERO@soton.ac.uk

Phone: 023 8120 5154

SAE Reporting

Email: ctu@soton.ac.uk

 

Essential Trial Documents

NERO - Protocol, v4.0 13-Oct-2022

NERO - Summary PIS, v1.0 29-Apr-2022

NERO - PIS, v3.0 25-Aug-2022

NERO - Site Training Log Template, v1.0 16-May-2022

NERO - Consent Form, v2.0 29-Apr-2022

NERO - GP Letter, v1.0 09-Mar-2022

NERO - Patient Drug Diary v1.0 09-Mar-2022

NERO - Patient Information Card v1.0 16-May-2022

NERO - Site Delegation Log v1.0 16-May-2022

NERO - Pregnancy Consent Form V1.0 31-May-22

NERO - Pregnancy IS V1.0 31-May-22

 

Investigator Site Files

NERO - Investigator Site File Index, v1 18-May-2022

NERO - Screening Log, v1 16-May-2022

NERO - Site Training Log Template, v1 16-May-2022

NERO - iMedidata Contact Sheet, v1 16-May-2022

NERO - Site Visit Log, v1 16-May-2022

NERO - Master Patient List, v1 16-May-2022

NERO - PI Protocol Acknowledgement, v2 25-Oct-22

NERO - eCRF Completion Guidance, v1 30-Jun-2022

NERO - TENALEA User Manual, v1 27-Jun-2022

 

Laboratory Documents

NERO - Laboratory Manual, v1 19-May-2022

NERO - Blood Storage and Shipment Logs, v1 16-May-2022

NERO - Tissue Tracking Log Samples sent by site to Central Lab, v1 16-May-2022

 

Pharmacy Site Files

NERO - Pharmacy Manual v1.0 09-Mar-2022

NERO - PRANCER user manual_TESARO IST Program - Site User Manual v1.0.

NERO Niraparib Destruction Log V1 16-May-2022

NERO Niraparib Returns Log V1 16-May-2022

NERO - Temperature Excursion form

 

Safety Documents

NERO - Instructions for Adverse and Serious Adverse Event Reporting V1 16-May-2022

NERO - Serious Adverse Event V1 16-May-2022

NERO - SAE - SUSAR Follow-up Form V1 16-May-2022

NERO - IB-2022-V14 GSK3985771 Niraparib Tosylate Monohydrate

Press releases, video clips and other external websites:

(University of Southampton cannot accept responsibility for external websites)

 

NERO opening, July 2022

NERO trial explainer video

 

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