Spots Global Cancer Trial Database for Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

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Trial Identification

Brief Title: Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

Official Title: A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.

Study ID: NCT04749602

Conditions

Renal Cell Cancer Metastatic

Non-small Cell Lung Cancer Metastatic

Pleural Effusion, Malignant

Interventions

Nivolumab

Study Description

Brief Summary: Patients with advanced cancers who have pleural effusion, especially those requiring pleural evacuation, experienced poorer survival when treated with immunotherapy. The pleura also acts as a natural barrier that can limit the penetration of immune checkpoint inhibitors. In this multicenter phase 2 study, the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with immune-sensitive metastatic cancers will be accessed.

Detailed Description: Patients ≥18 years old who have large volume of pleural effusion, required evacuation, and received systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor) for metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) will be eligible. Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.