NCT02610140 (Clinical Trials/ ANETUMAB RAVTANSINE/ BAY-94-9343)

Study Title
Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM). NCT02610140

Trial Description
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 (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.

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.

This trial is sponsored by Bayer®.

Study Data

  • Condition: Mesothelioma
  • Interventions:
    • Drugs used in this trial
      • Anetumab ravtansine (BAY 94-9343)
      • Vinorelbine
  • Phase: II
  • Enrollment: 248
  • Start: December 2015
  • Estimated Completion: July 2019
  • Last verified: July 2017
  • Last Updated: July 2017

Study Schematic

Image 1.0: A phase II trial with anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM) – NCT02610140. The main purpose of the trial was 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).

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Last Editorial review: July 27, 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.