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A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Published: November 15, 2019

Primary Outcome Measures

1. number of patients going to operating room for surgical resection [ Time Frame: 30 days of the initially planned date ]

Patients who experience a greater than 30 day toxicity induced delay of surgery will be counted as a failure for the primary feasibility endpoint.

Inclusion Criteria

  • Age ≥ 18 years
  • Karnofsky performance status > 70%
  • Pathologic diagnosis of malignant pleural mesothelioma.
  • At least one measurement must be >1.5 cm.
  • Potentially resectable by pleurectomy/decortication, as assessed by thoracic surgeon
  • Negative serum pregnancy test in women of childbearing potential
  • Female patients of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 5 months after the last administration of nivolumab and at least 6 months after last administration of pemetrexed, whichever is longer
  • Male patients with female partners of childbearing potential must agree to use a highly effective form of contraception for the duration of the study and for at least 7 months after the last administration of nivolumab and at least 3 months after the last administration of pemetrexed, whichever is longer
  • Adequate archival or fresh tissue for correlative analyses within 60 days prior to starting treatment as long as there was no interval cancer-directed therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required.
  • Absolute neutrophil count ≥ 1000/mcL
  • Total bilirubin ≤ 1.5 mg/dl
  • AST and ALT ≤ 3.0 x upper limit of normal
  • Creatinine ≤ 1.5 x upper limit of normal
  • Negative HIV serology blood test

Exclusion Criteria

  • Prior treatment with chemotherapy or immunotherapy for mesothelioma
  • Autoimmune disease requiring systemic immune modulating treatment during the past two years
  • Pregnant or lactating women
  • Known active hepatitis B or hepatitis C
  • Current use of systemic prednisone at dose ≥ 10 mg daily (or the equivalent dose with another corticosteroid)
  • Serious concurrent medical illness or another active cancer requiring treatment
  • Active pneumonitis
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