Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (MPM)

Stopped early · Phase 2

Conditions studied: Malignant Pleural Mesothelioma

In brief

The purpose of this study is to evaluate whether CRS-207 with pembrolizumab is safe and effective in adults with MPM who have failed prior anti-cancer therapy.

Key facts

Study ID

NCT03175172

Run by

Aduro Biotech, Inc.

People needed

10

Starts

2017-05-31

Expected to finish

2018-01-31

Last updated by the study team

2019-04-04

Who can join

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

You may qualify if…

• Histologically-confirmed epithelial or biphasic MPM; biphasic tumors must have a predominantly (≥50%) epithelial component
• No more than 2 prior lines of anti-cancer therapy, one of which must have included pemetrexed and a platinum.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate organ and marrow function
• Adequate lung function; forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) ≥ 45% of predicted value as measured by spirometry; and oxygen saturation ≥ 90% on room air

You may not qualify if…

• Pleurodesis within 14 days prior to first dose of study drug
• Receiving tumor necrosis factor (TNF) pathway inhibitors, PI3 kinase inhibitors, systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
• Active secondary malignancy
• Prior anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug, or not recovered from adverse effects due to agents administered more than 4 weeks earlier
• Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug
• History of (non-infectious) pneumonitis that required steroids or current pneumonitis
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or agents targeting other checkpoint pathways (e.g. CTLA-4)
• Prior immunotherapy with CRS-207 or any other Listeria-based agent, therapeutic cancer vaccine, or adoptive T cell immunotherapy
• Implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g., Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.

Where it is running

• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• NIH National Cancer Institute — Bethesda, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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