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

Phase 2

Completed

• Conditions: Renal Cell Cancer Metastatic; Pleural Effusion, Malignant; Non-small Cell Lung Cancer Metastatic
• Interventions: Drug: Nivolumab

• Registration Number: NCT04749602
• Lead Sponsor: Kidney Cancer Research Bureau

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.

Study Timeline

• Study Start: 2020-08-10
• Study First Submitted: 2021-02-07
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-11
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer	Nivolumab	Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma	Nivolumab	Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Primary Outcome Measures

Name	Time	Method
3-month recurrence-free survival	3 months	Proportion of patients who will be without signs of radiographic recurrence after 3 months

Secondary Outcome Measures

Name	Time	Method
Rate of any grade adverse events	3 months	Percentage of patients who will experience any grade adverse events (according to CTCAE criteria ver. 5.0) associated with intrapleural nivolumab use

Trial Locations

Locations (5)

Medicine 24/7 clinic; 🇷🇺 Moscow, Russian Federation

Kidney Cancer Research Bureau; 🇷🇺 Moscow, Russian Federation

I.M. Sechenov First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation

Yauza clinical hospital; 🇷🇺 Moscow, Russian Federation

Medscan; 🇷🇺 Moscow, Russian Federation