RecruitingPleural Biphasic MesotheliomaPleural Sarcomatoid Mesothelioma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Sponsor: Alliance for Clinical Trials in Oncology

You may qualify if…

✓ 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

You may not qualify if…

✕ 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