Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (MPM)
Condition: Malignant Pleural Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: CRS-207; Pembrolizumab
Intervention description: Administered by IV infusion over approximately 1 hour.; Administered by IV infusion over approximately 30 minutes.
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          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. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          4. Adequate organ and marrow function

          5. 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

        Exclusion Criteria

          1. Pleurodesis within 14 days prior to first dose of study drug

          2. 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

          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.