Related Experiment Video
Updated: Jul 10, 2025
Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
Published on: July 25, 2020
Evaluating niraparib versus active symptom control in patients with previously treated mesothelioma (NERO): a study
Dean Fennell1, Daniel Griffiths2, Zina Eminton3
1Mesothelioma Research Programme, Department of Genetics and Genome Biology, University of Leicester & University Hospitals of Leicester NHS Trust, Leicester, UK.
Background:
Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.
Methods:
NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.
Ethics And Dissemination:
The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.
Trial Registration Number:
ISCRTN16171129; NCT05455424.
Insights
The NERO trial investigates niraparib, a PARP inhibitor, for relapsed malignant mesothelioma. This study aims to improve treatment options for patients with this aggressive cancer.
Area of Science:
- Oncology
- Clinical Trials
- Cancer Therapeutics
Background:
- Malignant mesothelioma is a rare but aggressive cancer with limited treatment options.
- Previous research (MiST1 trial) showed promise for Poly (ADP-ribose) polymerase (PARP) inhibitors in mesothelioma.
- There is a critical need for effective therapies in relapsed mesothelioma patients.
Purpose of the Study:
- To evaluate the efficacy and safety of niraparib, a PARP inhibitor, in patients with relapsed malignant mesothelioma.
- To assess the benefit of niraparib in combination with active symptom control (ASC) versus ASC alone.
Main Methods:
- NERO is a phase II, multicentre, randomized trial recruiting 84 patients with relapsed mesothelioma.
- Patients are randomized 2:1 to receive niraparib plus ASC or ASC alone, stratified by histology and response to prior platinum-based chemotherapy.
- The primary endpoint is progression-free survival, with secondary endpoints including overall survival and safety.
Main Results:
- This section is not applicable as the abstract does not contain results yet.
- The study is currently recruiting patients.
- Data will be analyzed and published upon completion.
Conclusions:
- If NERO demonstrates niraparib's safety and efficacy, it could pave the way for larger, late-phase trials.
- This research may lead to a new therapeutic option for patients with relapsed mesothelioma.
- The findings could significantly impact the management of malignant mesothelioma.
More Related Videos
04:04Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
09:31Orthotopic Implantation and Peripheral Immune Cell Monitoring in the II-45 Syngeneic Rat Mesothelioma Model
Published on: October 2, 2015
Related Concept Videos
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...
02:50Combination Therapies and Personalized Medicine
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
01:28Chemotherapy-Induced Nausea and Vomiting: Neurokinin-1 Receptor Antagonists