Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

Inclusion Criteria:

• Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma

• Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNMClassification of Malignant Tumours 8th edition

• Measurable disease or non-measurable disease as defined

• No prior treatment which would be considered treatment for the primary neoplasm orimpact the primary endpoint

• No treatment with hormones or other chemotherapeutic agents except for hormonesadministered for non-disease-related conditions (e.g., insulin for diabetes and orhormonal therapy for breast, prostate cancer etc.)

• Not pregnant and not nursing, because this study involves an investigational agentwhose genotoxic, mutagenic and teratogenic effects on the developing fetus andnewborn are unknown

• Therefore, for women of childbearing potential only, a negative pregnancy testdone =< 14 days prior to registration is required

• Age >= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky >= 60%

• Absolute neutrophil count (ANC) >= 1,000/mm^3

• Leukocytes >= 2,000/mm^3

• Platelet count >= 100,000/mm^3

• Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 40 mL/min

• Total bilirubin =<1.5 x ULN, except patients with Gilbert Syndrome who can havetotal bilirubin < 3.0 mg/dl

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN

• Alkaline (alk) phosphatase (phos) =< 3.0 x ULN

• No active, known or suspected autoimmune disease except for vitiligo, type Idiabetes mellitus, residual hypothyroidism due to autoimmune condition onlyrequiring hormone replacement, psoriasis not requiring systemic treatment, orconditions not expected to recur in the absence of an external trigger

• No active systemic infection requiring therapy, as well as positive tests forhepatitis B surface antigen or hepatitis C antibody

• No history of any other condition that may require the initiation of anti-tumornecrosis factor alpha (TNFalpha) therapies or other immunosuppressant medicationsduring the study

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviraltherapy with undetectable viral load within 6 months are eligible for this trial

• Patients with known history or current symptoms of cardiac disease, or history oftreatment with cardiotoxic agents, should have a clinical risk assessment of cardiacfunction using the New York Heart Association Functional Classification. To beeligible for this trial, patients should be class 2B or better

• Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial

• STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and nothave an unresolved adverse event that would preclude surgery

• STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would precluderesection

• STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =< 2 or Karnofsky >= 60%

• STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) > 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) > 35%

• STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no morethan 90 days after the last dose of neoadjuvant therapy

Exclusion Criteria:

• No patients deemed to be unresectable or poor surgical candidates

• No patients with chest wall invasion, peritoneal spread, contralateral pleuralinvolvement, mediastinal organ involvement, vertebral involvement, or metastases tocontralateral intrathoracic lymph nodes, or any supraclavicular nodes

• No patients with a history of symptomatic interstitial lung disease