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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)

Phase 3
18 Years
Open (Enrolling)
Malignant Pleural Mesothelioma

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Trial Information

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
clinical practice.

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.

Inclusion Criteria:

- Age ≥ 18 years

- Histologically or cytological confirmed malignant pleural mesothelioma of any of the
following subtype: epithelial, sarcomatoid, mixed, or unknown

- Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen
administered for advanced or metastatic disease. Prior use of a biological agent in
combination with a pemetrexed-based regimen and prior administration of intrapleural
cytotoxic agents are allowed. Patients who have previously received anthracyclines
should not receive doxorubicin

- ECOG Performance Status 0 - 2

- Life expectancy of ≥ 12 weeks

- Adequate baseline bone marrow, hepatic and renal function, defined as follows:

1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL

2. Bilirubin ≤ 1.5 x ULN

3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in
presence of liver metastasis

4. Serum creatinine < 1.5 x ULN

- Measurable or non-measurable disease according to MPM-modified RECIST criteria

- Patients may have had prior therapy providing the following conditions are met:

1. Surgery: wash-out period of 14 days

2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days

- Patients must give written informed consent to participate in the study

Exclusion Criteria:

- Patients must not receive any other investigational agents while on study

- Patients with myocardial infarction within the last six months, unstable angina, New
York Heart Association (NYHA) grade II or greater congestive heart failure, or
serious cardiac arrhythmia requiring medication

- Uncontrolled hypertension

- QTc interval (congenital or acquired) > 450 ms

- History or evidence upon physical examination of CNS disease unless adequately
treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with
standard medical therapy, or history of stroke)

- Patients with active or uncontrolled systemic disease/infections or with serious
illness or medical conditions, which is incompatible with the protocol

- Known hypersensitivity/allergic reaction to human albumin preparations or to any of
the excipients

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol

- Pregnancy or lactation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Description:

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

Outcome Time Frame:

every 6-12 weeks

Safety Issue:


Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.


Italy: Ethics Committee

Study ID:




Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Malignant Pleural Mesothelioma
  • MPM
  • NGR-hTNF
  • NGR-hTNF plus BIC
  • Randomized double-blind phase III study
  • Mesothelioma



Columbia UniversityNew York, New York  10032-3784
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Wilshire Oncology Medical GroupGlendora, California  91741
Johns HopkinsBaltimore, Maryland  21231
City of Hope-Comprehensive Cancer CenteDuarte, California  91010
H. Lee Moffitt ancer Center and Research InstituteTampa, Florida  33612
UTsouthwestern medical centerDallas, Texas  75390