NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
Currently, there are no regulatory-approved or widely accepted treatment options for
patients failing a standard pemetrexed-based chemotherapy regimen.
For this reason, the best supportive care (BSC) alone might be considered as a standard
reference for a randomized phase III trial in this setting.
However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or
vinorelbine) with a well-documented safety profile and antitumor activity are also used in
Therefore, the best investigator's choice (BIC) between either best supportive care alone or
combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine,
or vinorelbine) might be considered as an acceptable reference arm as well in this setting.
The current phase III study aims to show a superior efficacy in terms of overall survival
duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM
patients progressing after a standard pemetrexed-based chemotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall Survival (OS)
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
every 6-12 weeks
Antonio Lambiase, MD
Italy: Ethics Committee
|Columbia University||New York, New York 10032-3784|
|University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|Wilshire Oncology Medical Group||Glendora, California 91741|
|Johns Hopkins||Baltimore, Maryland 21231|
|City of Hope-Comprehensive Cancer Cente||Duarte, California 91010|
|H. Lee Moffitt ancer Center and Research Institute||Tampa, Florida 33612|
|UTsouthwestern medical center||Dallas, Texas 75390|