A Study of Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma

Overview

About this study

The main purpose of this study is to assess the effectiveness and safety of treatment with anetumab ravtansine versus vinorelbine  for progression free survival in patients with stage IV mesothelin overexpressing type of malignant pleural mesothelioma. 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20260185

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