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Brief Title Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
Official Title 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
Principal Investigator Kindler, Hedy
Brief 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). 183 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.
Gender Both
Ages 18 Years
Enrollment 183
Accepts Healthy Volunteers No
Lead Sponsor BayerIndustry
Collaborator ImmunoGen and MorphoSysOther
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Mesothelioma
Detail for Health Professional (on clinicaltrials.gov)
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