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

Completed · Phase 2

Conditions studied: Mesothelioma

In brief

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.

Key facts

Study ID

NCT02610140

Run by

Bayer

People needed

248

Starts

2015-12-03

Expected to finish

2019-09-06

Last updated by the study team

2020-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 investigator in consultation with the ophthalmologist.
• Brain metastases, meningeal tumours or other 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

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Norwich, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Bethesda, Maryland, United States
• Study site — Rochester, Minnesota, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — St Leonards, New South Wales, Australia
• Study site — Woolloogabba, Queensland, Australia
• Study site — Adelaide, South Australia, Australia
• Study site — Richmond, Victoria, Australia
• Study site — Nedlands, Western Australia, Australia
• Study site — Bruxelles - Brussel, Belgium
• Study site — Edegem, Belgium
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Liège, Belgium
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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