Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
Status:
Completed
Trial end date:
2019-09-06
Target enrollment:
Participant gender:
Summary
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine
versus vinorelbine in progression free survival in patients with stage IV mesothelin
overexpressing malignant pleural mesothelioma (MPM).
210 eligible patients will be randomized to receive either anetumab ravtansine every three
weeks or weekly vinorelbine.
Treatment will continue until centrally confirmed disease progression or until another
criterion is met for withdrawal from the study. Patients will enter follow up phase to
capture safety and endpoint data as required.
Efficacy will be measured by evaluating progression free survival from randomization.
Radiological tumor assessments will be performed at defined time points until the patient's
disease progresses.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival
or fresh biopsy tissue may also be collected for central pathology review and biomarkers.