Skip to main content

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Thierry M Jahan

Description

Summary

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.

Official Title

A Phase 2 Single-arm Study to Evaluate Safety and Efficacy of CRS-207 With Pembrolizumab in Adults With Previously-Treated Malignant Pleural Mesothelioma

Details

The population for this study will consist of approximately 35 adults with histologically-confirmed MPM (epithelial or biphasic) whose disease has progressed after 1-2 prior anti-cancer therapies.

Keywords

Malignant Pleural Mesothelioma Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Histologically-confirmed epithelial or biphasic MPM; biphasic tumors must have a predominantly (≥50%) epithelial component
  2. No more than 2 prior lines of anti-cancer therapy, one of which must have included pemetrexed and a platinum.
  3. Measurable disease as defined by modified RECIST for MPM (Byrne and Nowak, 2004)
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  5. Adequate organ and marrow function
  6. 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 CAN'T join if...

  1. Pleurodesis within 14 days prior to first dose of study drug
  2. Receiving 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
  3. Active secondary malignancy
  4. 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
  5. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of study drug
  6. History of (non-infectious) pneumonitis that required steroids or current pneumonitis
  7. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or agents targeting other checkpoint pathways (e.g. CTLA-4)
  8. Prior immunotherapy with CRS-207 or any other Listeria-based agent, therapeutic cancer vaccine, or adoptive T cell immunotherapy
  9. 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.

Locations

  • University of Chicago Medical Center accepting new patients
    Chicago, Illinois, 60637, United States
  • H. Lee Moffitt Cancer Center accepting new patients
    Tampa, Florida, 33612, United States
  • NIH National Cancer Institute not yet accepting patients
    Bethesda, Maryland, 20892, United States
  • Abramson Cancer Center of the University of Pennsylvania accepting new patients
    Philadelphia, Pennsylvania, 19104, United States
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone accepting new patients
    New York, New York, 10016, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aduro Biotech, Inc.
ID
NCT03175172
Phase
Phase 2
Lead Scientist
Thierry M Jahan
Study Type
Interventional
Last Updated
July 1, 2017
I’m interested in this study!