A Phase 3 British clinical trial will test whether the immune checkpoint inhibitor Opdivo (nivolumab) can help mesothelioma patients whose disease relapsed after platinum-based chemotherapy.
The CONFIRM trial (NCT03063450), funded by Cancer Research UK, has begun enrolling patients. The goal is to have 304 participants at 20 sites in London, Southampton, Leicester, and other cities.
The University of Southampton Centre for Cancer Immunology, the first British facility devoted solely to cancer immunology research, will be conducting the trial.
Bristol-Myers Squibb and Ono Pharmaceutical are marketing Opvido. Ono and Medarex developed the drug. Bristol-Myers acquired Medarex in 2009.
“The UK has one of the world’s highest incidences of mesothelioma, and currently there aren’t many ways to treat it,” Professor Gareth Griffiths, the study’s co-chief investigator, said in a press release. “Boosting the immune system by releasing killer T-cells that have previously been blocked could offer us a new way to treat more patients with this devastating disease,” said Griffiths, who is with the Southampton Clinical Trials Unit at the University of Southampton.
“Preliminary studies targeting PD-1 in mesothelioma have shown promising activity,” said Professor Dean Fennell of the University of Leicester, who will lead the study. “CONFIRM aims to definitively assess the true benefit of nivolumab for patients with relapsed mesothelioma in a setting where there is an unmet need. Critically, we aim to understand why patients respond (or not) to this drug, and identify biomarkers to ensure that we can personalise therapy to maximize the benefit for patients.”
The randomized, double-blind, placebo-controlled trial will run for four years, with the last patients receiving a minimum of six months follow-up. The participants will be mesothelioma patients who have had at least three relapse after platinum-based chemo.
Participants will be randomized to receive either 240 mg Opdivo or a placebo every two weeks for 12 months or until their disease progresses. Twice as many patients will receive Opdivo as the placebo.
The University of Southampton Centre for Cancer Immunology will be operational in the summer of 2018. It will bring world-leading cancer scientists together under the same roof to develop life-saving immunotherapies.
The University of Southhampton is raising the £25 million needed to open the facility. That’s equivalent to $32.4 million.
“The university has made major advances in tumour immunology and immunotherapy over the past 40 years, and we enjoy a strong reputation for our ‘bench to bedside’ approach,” said Professor Tim Elliott, director of the Centre for Cancer Immunology. “The new centre will go a long way in helping many more people with cancer become free of the disease, and we hope this new trial to fight a particularly sinister type of cancer will be the first of many successful trials.”
