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

• Status: Recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kidney Cancer Research Bureau
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Patients ≥18 years old

• Large volume of pleural effusion (1 liter and more), required evacuation

• Systemic therapy with a checkpoint inhibitor (monotherapy or combination with another checkpoint inhibitor)

• Metastatic cancers (renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC)

Exclusion Criteria:

• Autoimmune disorders

• Previous treatment for