Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
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.
|Mesothelioma||Drug: Anetumab ravtansine (BAY 94-9343) Drug: Vinorelbine||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- Progression Free Survival [ Time Frame: Approx. 22 months ]Defined as time from randomization until disease progression or death. Patients not experiencing death or progression will be censored at the last tumor assessment.
- Overall survival (OS) [ Time Frame: Approx. 42 months ]Defined as time from randomization until death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored at the last known alive date.
- Patient-reported outcomes (PROs) [ Time Frame: Approx. 22 months ]PROs: Time to worsening of symptoms characteristic of mesothelioma, time to worsening of pain, time to improvement of symptoms characteristic of mesothelioma and time to improvement of pain. Symptoms will be assessed using the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma (MDASI-MPM) and the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso).
- Objective response rate (ORR) [ Time Frame: Approx. 22 months ]A patient is a responder if the patient has a confirmed tumor response on-study of (complete response) CR or PR, as determined by the central radiological reviewer per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria for MPM. The ORR in each arm is the number of responders divided by the number of randomized patients.
- Duration of response (DOR) [ Time Frame: Approx. 42 months ]Defined as proportion of patients achieving CR, PR, or (Stable disease) SD per mRECIST criteria, as determined by the central radiological reviewer.
- Number of participants with treatment emergent adverse events as a measure of safety and tolerability [ Time Frame: Approx. 22 months ]
- Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Approx. 22 months ]
- Disease control rate (DCR) [ Time Frame: Approx. 22 months ]Defined as proportion of patients achieving CR, PR, or (Stable disease) SD per mRECIST criteria, as determined by the central radiological reviewer.
- Durable Response Rate (DRR) [ Time Frame: Approx. 42 months ]Defined in responders as a responder with a duration of response of 180 days or more as determined by the central radiological reviewer.
|Actual Study Start Date:||December 3, 2015|
|Estimated Study Completion Date:||July 29, 2019|
|Estimated Primary Completion Date:||June 15, 2017 (Final data collection date for primary outcome measure)|
Experimental: BAY 94-9343
Drug Anetumab ravtansine given Intravenously (IV)
Drug: Anetumab ravtansine (BAY 94-9343)
Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
Active Comparator: Vinorelbine
Drug Vinorelbine given Intravenously
Starting dose: 30mg/m² administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02610140
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|Study Director:||Bayer Study Director||Bayer|