Clinical Trials /

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

NCT02610140

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 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.

Related Conditions:
  • Pleural Mesothelioma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant <span class="go-doc-concept go-doc-disease">Pleural Mesothelioma</span> (MPM)

Title

  • 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
  • Clinical Trial IDs

    NCT ID: NCT02610140

    ORG ID: 15743

    NCI ID: 2012-003650-88

    Trial Conditions

    Mesothelioma

    Trial Interventions

    Drug Synonyms Arms
    Anetumab ravtansine (BAY 94-9343) BAY 94-9343
    Vinorelbine Vinorelbine

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    BAY 94-9343 Experimental Drug Anetumab ravtansine given Intravenously (IV) Anetumab ravtansine (BAY 94-9343)
    Vinorelbine Active Comparator Drug Vinorelbine given Intravenously Vinorelbine

    Eligibility Criteria

    Inclusion Criteria:

    - Histological documentation of malignant pleural mesothelioma (MPM) overexpressing
    mesothelin

    - Unresectable locally advanced or metastatic MPM after locally confirmed progression
    on 1st line treatment with platinum in combination with pemetrexed.

    - Patients must have measurable disease

    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

    - Life expectancy of at least 3 months.

    - Adequate bone marrow, liver and renal function

    - Left ventricular ejection fraction (LVEF) 50% or the lower limit of normal (LLN)
    according to local institution ranges of normality.

    Exclusion Criteria:

    - More than 1 previous systemic anti-cancer therapy line

    - Patients with corneal epitheliopathy or any eye disorder that may predispose the
    patients to this condition at the discretion of the ophthalmologist.

    - Symptomatic brain metastases or meningeal tumors or other uncontrolled metastases in
    the central nervous system

    - Evidence of history of bleeding diathesis.

    - Ongoing or active infection (bacterial, fungal, or viral) of National Cancer
    Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03
    Grade > 2.

    - Pre-existing cardiac conditions.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Overall survival (OS)

    Patient-reported outcomes (PROs)

    Objective response rate (ORR)

    Duration of response (DOR)

    Number of participants with treatment emergent adverse events as a measure of safety and tolerability

    Number of participants with serious adverse events as a measure of safety and tolerability

    Disease control rate (DCR)

    Trial Keywords