Title |
CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial
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Published in |
Trials, April 2018
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DOI | 10.1186/s13063-018-2602-y |
Pubmed ID | |
Authors |
Dean A. Fennell, Emma Kirkpatrick, Kelly Cozens, Mavis Nye, Jason Lester, Gerard Hanna, Nicola Steele, Peter Szlosarek, Sarah Danson, Joanne Lord, Christian Ottensmeier, Daniel Barnes, Stephanie Hill, Mihalis Kalevras, Tom Maishman, Gareth Griffiths |
Abstract |
Mesothelioma is an incurable, apoptosis-resistant cancer caused in most cases by previous exposure to asbestos and is increasing in incidence. It represents a growing health burden but remains under-researched, with limited treatment options. Early promising signals of activity relating to both PD-L1- and PD-1-targeted treatment in mesothelioma implicate a dependency of mesothelioma on this immune checkpoint. There is a need to evaluate checkpoint inhibitors in patients with relapsed mesothelioma where treatment options are limited. The addition of 12 months of nivolumab (anti-PD1 antibody) to standard practice will be conducted in the UK using a randomised, placebo-controlled phase III trial (the Cancer Research UK CONFIRM trial). A total of 336 patients with pleural or peritoneal mesothelioma who have received at least two prior lines of therapy will be recruited from UK secondary care sites. Patients will be randomised 2:1 (nivolumab:placebo), stratified according to epithelioid/non-epithelioid, to receive either 240 mg nivolumab monotherapy or saline placebo as a 30-min intravenous infusion. Treatment will be for up to 12 months. We will determine whether the use of nivolumab increases overall survival (the primary efficacy endpoint). Secondary endpoints will include progression-free survival, objective response rate, toxicity, quality of life and cost-effectiveness. Analysis will be performed according to the intention-to-treat principle using a Cox regression analysis for the primary endpoint (and for other time-to-event endpoints). The outcome of this trial will provide evidence of the potential benefit of the use of nivolumab in the treatment of relapsed mesothelioma. If found to be clinically effective, safe and cost-effective it is likely to become the new standard of care in the UK. EudraCT Number: 2016-003111-35 (entered on 21 July 2016); ClinicalTrials.gov, ID: NCT03063450 . Registered on 24 February 2017. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 14 | 78% |
Unknown | 4 | 22% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 13 | 72% |
Practitioners (doctors, other healthcare professionals) | 5 | 28% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 72 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 9 | 13% |
Researcher | 9 | 13% |
Student > Doctoral Student | 6 | 8% |
Student > Ph. D. Student | 6 | 8% |
Student > Master | 5 | 7% |
Other | 11 | 15% |
Unknown | 26 | 36% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 12 | 17% |
Nursing and Health Professions | 7 | 10% |
Pharmacology, Toxicology and Pharmaceutical Science | 7 | 10% |
Biochemistry, Genetics and Molecular Biology | 5 | 7% |
Business, Management and Accounting | 3 | 4% |
Other | 11 | 15% |
Unknown | 27 | 38% |