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

February 10, 2021 updated by: Kidney Cancer Research Bureau

A Phase II Trial of 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • I.M. Sechenov First Moscow State Medical University
        • Contact:
      • Moscow, Russian Federation
        • Recruiting
        • Kidney Cancer Research Bureau
        • Contact:
      • Moscow, Russian Federation
        • Recruiting
        • Medicine 24/7 clinic
        • Contact:
      • Moscow, Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • Yauza clinical hospital
        • Contact:
          • Vladislav Kosyrev
          • Phone Number: +7 (495) 234-42-42
          • Email: info@yamed.ru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrapleural instillation of the nivolumab
Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
Drug: Nivolumab
40 mg of the nivolumab will be used intrapleurally (once).
Other Names:
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-month recurrence-free survival
Time Frame: 3 months
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
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kidney Cancer Research Bureau

Investigators

  • Principal Investigator: Ilya Tsimafeyeu, M.D., Kidney Cancer Research Bureau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCRB-Hadassah-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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