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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma<br>Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. | Drug: Nivolumab<br>* 40 mg of the nivolumab will be used intrapleurally (once).<br>* Other names: Opdivo;|
| Experimental: Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer<br>Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. | Drug: Nivolumab<br>* 40 mg of the nivolumab will be used intrapleurally (once).<br>* Other names: Opdivo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month recurrence-free survival | Proportion of patients who will be without signs of radiographic recurrence after 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of any grade adverse events | Percentage of patients who will experience any grade adverse events (according to CTCAE criteria ver. 5.0) associated with intrapleural nivolumab use | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nivolumab, Intrapleural irrigation, Pleural carcinomatosis