Phase II anetumab ravtansine as 2nd line treatment for MPM
Research type
Research Study
Full title
A randomized, open-label, active-controlled, Phase II study of intravenous anetumab\nravtansine (BAY 94-9343) or vinorelbine in patients with advanced or metastatic\nmalignant pleural mesothelioma overexpressing mesothelin and progressed on first line\nplatinum/pemetrexed-based chemotherapy
IRAS ID
187884
Contact name
James Spicer
Contact email
Eudract number
2012-003650-88
Duration of Study in the UK
1 years, 11 months, 1 days
Research 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). \n210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine. \nTreatment will continue until centrally confirmed disease progression (PD) 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. \nEfficacy 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. \nBlood 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. \n \n
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0473
Date of REC Opinion
20 Nov 2015
REC opinion
Further Information Favourable Opinion