NCT04749602

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Kidney Cancer Research Bureau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Cancer Metastatic
• Non-small Cell Lung Cancer Metastatic
• Pleural Effusion, Malignant

Interventions

Type	Name	Description
DRUG	Nivolumab	40 mg of the nivolumab will be used intrapleurally (once).

Timeline

• Start date: 2020-08-10
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-02-11
• Last updated: 2023-03-08

Locations

5 sites across 1 country: Russia