Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma

Completed · Phase 1

Conditions studied: Malignant Pleural Mesothelioma

In brief

This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such as mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.

Key facts

Study ID: NCT01675765
Run by: Aduro Biotech, Inc.
People needed: 60
Starts: 2014-09-03
Expected to finish: 2019-08-19
Last updated by the study team: 2020-09-30

Who can join

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

You may qualify if…

Have histologically confirmed epithelial or biphasic MPM not amenable to potentially curative surgical resection (subjects with biphasic tumors that have a predominantly (≥50%) sarcomatoid component will be excluded)
Be at least 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have an anticipated life expectancy of greater than 6 months
For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
Be willing and able to give written informed consent, and be able to comply with all study procedures
Have adequate organ function as defined by specified laboratory values

You may not qualify if…

A candidate for curative surgery
Surgery within 2 weeks prior to dosing
Prior radiotherapy or biologic therapy
Treatment with an investigational agent within 4 weeks before dosing
Prior systemic chemotherapy
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Documented and ongoing brain metastases
Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
Have clinically significant and/or malignant pleural effusion
Known or suspected allergy or hypersensitivity to yeast or any other component of CRS-207 (e.g., glycerol), Platinol or platinum-containing compounds, or pemetrexed
Used any systemic steroids within 28 days of study treatment
Use more than 3 g/d of acetaminophen
An artificial (prosthetic) joint or other artificial implant or device that cannot be easily removed (with some exceptions for dental and breast implants and biliary stents and mediports)
Infection with HIV or hepatitis B or C at screening
Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
Be a woman who is pregnant or breastfeeding
Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Where it is running

University of California at San Francisco — San Francisco, California, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
University of Chicago Medical Center — Chicago, Illinois, United States
National Cancer Institute — Bethesda, Maryland, United States
University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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