Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma (NCT02863055) | Clinical Trial Compass
TerminatedPhase 2
Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma
Stopped: lack of scientific relevance (change in the treatment landscape) and poor recruitment
Belgium, Italy, United Kingdom37 participantsStarted 2018-02-04
Plain-language summary
This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological diagnosis of unresectable Malignant Pleural Mesothelioma (MPM);
* Response or Stable disease according to modified RECIST criteria \[48\] after first line platinum-pemetrexed chemotherapy for 4-6 cycles;
* Last platinum chemotherapy dose administered within 60 days (i.e. randomization must occur within 60 days from the last dose of the last cycle of platinum-pemetrexed chemotherapy);
* Age \>18 years;
* ECOG performance status (PS) 0-2;
* Life expectancy of at least 12 weeks in the opinion of the investigator;
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose
Exclusion Criteria:
* prior systemic anticancer therapy including cytotoxic therapy or immune-checkpoint inhibitor, for MPM, other than first line platinum-based doublet chemotherapy;
* previous extra-pleural pneumonectomy (other forms of previous surgery eg pleurectomy are acceptable);
* previous Vascular Endothelial Growth Factor (VEGF) inhibitors (eg bevacizumab, sorafenib, etc);
* treatment with other investigational drugs or treatment in another clinical interventional trial within the past 4 weeks before start of therapy or concomitantly with the trial;
* patients that, in the opinion of the investigator, have reduced performance status by 2 ECOG levels (e.g. PS 0 to 2 or PS 1 to 3) from beginning to completion of 1st line chemotherapy;
* radiotherapy (with the excepti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you find out why it was stopped early, and does that affect what we know about whether nintedanib is safe or effective for my mesothelioma?
2Since this was a Phase 2 trial measuring progression-free survival, does the available data give any meaningful signal about whether nintedanib actually slows disease progression, or is the evidence still too limited to draw conclusions?
3Nintedanib is described here as a 'switch maintenance' treatment given after first-line chemotherapy — is that the right timing in my treatment plan, and are there other maintenance options we should be comparing it against?
4Because the trial was terminated, would there be any other active studies or approved treatments for pleural mesothelioma that might be a stronger option for me right now?
5Given that recruitment was terminated, is nintedanib available to me at all outside of a clinical trial, and would my diagnosis and treatment history even make me a candidate worth discussing with a specialist?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival
Timeframe: 6 months
Trial details
NCT IDNCT02863055
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC