Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
Pleural Biphasic Mesothelioma, Pleural Sarcomatoid Mesothelioma
About this trial
This is an interventional treatment trial for Pleural Biphasic Mesothelioma
Eligibility Criteria
Inclusion Criteria: Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification 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 or impact the primary endpoint No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.) Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 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 have total 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 I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection 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 more than 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 pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes No patients with a history of symptomatic interstitial lung disease
Sites / Locations
- Kingman Regional Medical CenterRecruiting
- PCR OncologyRecruiting
- Beebe South Coastal Health CampusRecruiting
- Beebe Medical CenterRecruiting
- Delaware Clinical and Laboratory Physicians PARecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana HospitalRecruiting
- Beebe Health CampusRecruiting
- Christiana Care Health System-Wilmington HospitalRecruiting
- Northwestern UniversityRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Christiana Care - Union HospitalRecruiting
- Carson Tahoe Regional Medical CenterRecruiting
- Cancer and Blood Specialists-HendersonRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- Comprehensive Cancer Centers of Nevada-Horizon RidgeRecruiting
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven HillsRecruiting
- Comprehensive Cancer Centers of Nevada-Southeast HendersonRecruiting
- GenesisCare USA - HendersonRecruiting
- Las Vegas Urology - Green ValleyRecruiting
- Las Vegas Urology - PebbleRecruiting
- Urology Specialists of Nevada - Green ValleyRecruiting
- Las Vegas Urology - PecosRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- University Medical Center of Southern NevadaRecruiting
- Hope Cancer Care of NevadaRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- Urology Specialists of Nevada - CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- Las Vegas Prostate Cancer CenterRecruiting
- Las Vegas Urology - SunsetRecruiting
- Urology Specialists of Nevada - SouthwestRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Ann M Wierman MD LTDRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- GenesisCare USA - Vegas TenayaRecruiting
- Las Vegas Urology - Cathedral RockRecruiting
- Las Vegas Urology - Smoke RanchRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Urology Specialists of Nevada - NorthwestRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- University Cancer CenterRecruiting
- Hope Cancer Care of Nevada-PahrumpRecruiting
- Renown Regional Medical CenterRecruiting
- Saint Mary's Regional Medical CenterRecruiting
- Radiation Oncology AssociatesRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Overlake Medical Center
- Valley Medical CenterRecruiting
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Treatment (nivolumab, ipilimumab, surgery)
Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.