Clinical Trials Search
Clinical Trial 18517
Cancer Type: Thoracic
Interventions:Anetumab Ravtansine (BAY 94-9343); Navelbine (Vinorelbine); Vinorelbine
Study Type: Treatment
Phase of Study: Phase II
A Randomized, Open-Label, Active-Controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients with Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-Based Chemotherapy
The main purpose of the 15743 study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in mesothelioma patients with mesothelin overexpression.
The primary objective of this study is to: Test the superiority of anetumab ravtansine monotherapy over vinorelbine in progression-free survival (PFS). The secondary objectives of this study are to: Test overall survival (OS). Evaluate pulmonary function. Evaluate patient-reported outcomes(PROs), symptom burden and health-related quality of life. Evaluate other indicators of treatment efficacy (indicators of tumor response). Evaluate safety. The other objectives of this study are to evaluate the: Pharmacokinetics (PK). Immunogenicity. Biomarkers.