This protocol applies to patients with newly diagnosed pleural mesothelioma whose histology is classified as nonepithelioid — either biphasic or sarcomatoid subtype — who have not received prior systemic therapy and have no medical contraindication to immunotherapy.
Nonepithelioid histology (biphasic or sarcomatoid) defines a distinct subpopulation within pleural mesothelioma. These patients are treatment-naive and are eligible for immunotherapy-based first-line treatment.
For this histologic subtype, first-line systemic therapy is immunotherapy-based. Chemotherapy alone is not the recommended approach when immunotherapy is feasible. The full protocol specifies the regimen, combination options, and duration guidance.
DOI: 10.1200/JCO-24-02425
In patients with newly diagnosed nonepithelioid mesothelioma, ipilimumab plus nivolumab immunotherapy should be offered as the recommended first-line treatment.
Ipilimumab plus nivolumab immunotherapy should be administered for a duration up to 2 years in the absence of disease progression or intolerable toxicity.
In patients with newly diagnosed pleural mesothelioma (epithelioid or nonepithelioid), chemoimmunotherapy with pembrolizumab and pemetrexed plus platinum-based chemotherapy may be offered as a first-line systemic treatment option.
In patients with nonepithelioid histology who have not received any prior systemic therapy, chemotherapy should not be offered unless there are medical contraindications to immunotherapy.
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