The CONFIRM mesothelioma clinical trial showed that the immunotherapy drug, nivolumab, could be a useful treatment for people whose mesothelioma has returned after chemotherapy.
A patient who participated in the study reports:
“I can go out and walk my dogs, I split logs for my wood burner, and I do my garden… I just get on with enjoying my life.”
The groundbreaking results offer the first-ever improvement in overall survival for patients with relapsed mesothelioma.
CONFIRM Phase III Clinical Trial Shows First-Ever Improvement For Relapsed Mesothelioma
The CONFIRM study, short for Checkpoint Blockade For Inhibition of Relapsed Mesothelioma, is a phase III clinical trial for the drug, nivolumab.
CONFIRM was a United Kingdom-based study that ran from 2017-2020. It was sponsored by the University of Southampton and looked at nivolumab as a treatment for mesothelioma that had come back after chemotherapy.
“The CONFIRM trial was the first-ever phase III in the relapse setting to meet a primary endpoint of improved survival.”
– Dean Fennell, MD, University of Leicester in England
The promising results of CONFIRM offer new hope to patients whose relapsed mesothelioma leaves them with very few options.
What Is a Phase III Mesothelioma Clinical Trial?
Clinical trials are studies performed on volunteers to ensure experimental medications or medical devices are safe and effective before they reach the general public.
Clinical trials begin as small and early (phase I) studies and continue over time to large and late-stage (phase III) studies.
The phases follow a typical series:
- Phase I: Lasts several months and involves 20-100 volunteers with the aim of studying safety and dosage. Approximately 70% of drugs move to the next phase.
- Phase II: Lasts up to 2 years and involves several hundred volunteers. The purpose is to study how effective a drug is and any side effects it may cause. Approximately 33% of drugs move to the next phase.
- Phase III: This is the final phase before FDA approval. Up to 3,000 volunteers are studied for anywhere between 1-4 years. Approximately 25-30% of drugs move to the next phase.
- Phase IV: This phase happens after a drug is already on the market in an ongoing effort to monitor the safety of a new drug.
Mesothelioma clinical trials are critical because most patients with the condition relapse after first-line treatment, which has historically been chemotherapy.
Sadly, there is currently no standard second-line therapy. Rather, it is common to try the first-line regimen again when a patient’s mesothelioma comes back.
The only other phase III clinical trial aimed at improving progression-free survival (PFS) in relapsed mesothelioma patients was PROMISE1. This trial, unfortunately, showed no improvement in PFS as compared with standard chemotherapy.
The positive outcome of CONFIRM is welcome news for mesothelioma patients and their loved ones.
Details of the CONFIRM Mesothelioma Clinical Trial
The drug being studied, nivolumab, is an immunotherapy treatment. Immunotherapy as a standard treatment for cancer is at a crucial stage. It is being approved more and more for non-small cell lung cancer.
However, first-line treatment options for mesothelioma remain limited and have historically relied on chemotherapy and radiation. The goal of CONFIRM was to find a way to change that.
Who Were the Participants?
The CONFIRM mesothelioma clinical trial involved 332 volunteers. To participate in the study, volunteers must have received at least two prior lines of therapy.
The mesothelioma patients who participated were:
- A median age of 70
- 75% male
- All but 5% of patients had pleural mesothelioma
Because mesothelioma patients who have relapsed often have little chance of survival, participating in a mesothelioma clinical trial such as CONFIRM gives them new hope. It is also a way to help advance the search for a cure.
As one CONFIRM volunteer put it, “I think it is so important for patients to be involved in research. When I was offered the chance to be part of the CONFIRM trial at Bournemouth Hospital, I jumped at it. It’s wonderful knowing that you are not only potentially helping yourself, but also helping improve treatment for more patients in the future.”
What Were the Findings?
The results of the CONFIRM mesothelioma clinical trial show clear evidence of improved survival.
Highlights of the CONFIRM study include:
- Median overall survival increased by almost 40%
- 12-month survival was 39.5% versus 26.9% with placebo
- Median PFS was 3 months versus 1.8 months with placebo
- 12-month PFS was 14.5% versus 4.9% with placebo
According to the Director of Clinical Trials at Cancer Research UK, these results mark a major breakthrough in the treatment of mesothelioma.
New Hope, But Some Questions Remain
Mesothelioma treatment options have made very little progress over the years. CONFIRM could be a major breakthrough that gives mesothelioma patients precious extra time with their loved ones.
“Nivolumab is deemed a safe and effective treatment and should be considered the new treatment option for patients with relapsed mesothelioma.”
– Dean Fennell, MD, University of Leicester in England
It is important to remember, however, that this is not a cure. Additionally, nivolumab did not improve overall survival in patients with non-epitheliod tumors.
CONFIRM also leaves doctors with unanswered questions that include:
- Is nivolumab better than chemotherapy as a first-line treatment?
- If it is, what would be the best second-line therapy for patients who received nivolumab as their initial treatment?
- What do we need to understand about predictive biomarkers to develop new second-line therapies?
While the CONFIRM study is a major breakthrough in treating relapsed mesothelioma, research should not end here. There is an urgent need for continued clinical trials to study and ultimately cure such an aggressive and deadly cancer.
What Does This News Mean for Mesothelioma Patients?
Mesothelioma clinical trials may help patients live longer. They may also give mesothelioma patients access to new and effective treatments before they reach the general public.
If you are interested in being in a mesothelioma clinical trial, it is very important to look at your options without delay. There may be a trial happening near you right now that you are eligible to join.
If you need assistance finding information, our team can talk with you about accessing and affording treatments — get a free case review and learn more.