A Study of Nivolumab and Chemotherapy Followed by Surgery for Mesothelioma

Prior treatment

• Prior treatment with chemotherapy or immunotherapy for mesothelioma
• 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

Other illness

• Autoimmune disease requiring systemic immune modulating treatment during the past two years
• Known active hepatitis B or hepatitis C
• Active pneumonitis

Other

• Pregnant or lactating women

• Age ≥ 18 years
• Karnofsky performance status \> 70%
• Pathologic diagnosis of malignant pleural mesothelioma.
• 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 analysis. Archival tissue will be deemed acceptable as long as their was no interval therapy prior to cycle 1 day 1 of protocol therapy. If sufficient archival or fresh tissue is not available, then a repeat biopsy at baseline prior to starting study treatment will be required as long as medically safe and feasible
• 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