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OpenTrials
Completed

NCT Number: NCT04749602

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

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.

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Key information

Conditions

Renal Cell Cancer Metastatic Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Metastatic Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

I.M. Sechenov First Moscow State Medical University, Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

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

Other names: Opdivo

Primary outcomes

  1. 3-month recurrence-free survival

    Time frame: 3 months

    Proportion of patients who will be without signs of radiographic recurrence after 3 months

Secondary outcomes

  1. Rate of any grade adverse events

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Kidney Cancer Research Bureau

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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