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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04749602

Enrollment

Registered

2021-02-11

Start date

2020-08-10

Completion date

2023-03-01

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Nivolumab, Intrapleural irrigation, Pleural carcinomatosis

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.

Interventions

DRUGNivolumab

40 mg of the nivolumab will be used intrapleurally (once).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026