A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

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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