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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Nivolumab

About this trial

This is an interventional treatment trial for Renal Cell Cancer Metastatic focused on measuring Nivolumab, Intrapleural irrigation, Pleural carcinomatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

I.M. Sechenov First Moscow State Medical University
Kidney Cancer Research Bureau
Medicine 24/7 clinic
Medscan
Yauza clinical hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma

Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer

Arm Description

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Outcomes

Primary Outcome Measures

3-month recurrence-free survival

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04749602

First Posted

February 7, 2021

Last Updated

March 6, 2023

Sponsor

Kidney Cancer Research Bureau

1. Study Identification

Unique Protocol Identification Number

NCT04749602

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

August 10, 2020 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kidney Cancer Research Bureau

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Nivolumab, Intrapleural irrigation, Pleural carcinomatosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma

Arm Type

Experimental

Arm Description

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Arm Title

Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer

Arm Type

Experimental

Arm Description

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Description

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

Primary Outcome Measure Information:

Title

3-month recurrence-free survival

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Rate of any grade adverse events

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilya Tsimafeyeu, M.D.

Organizational Affiliation

Kidney Cancer Research Bureau

Official's Role

Principal Investigator

Facility Information:

Facility Name

I.M. Sechenov First Moscow State Medical University

City

Moscow

Country

Russian Federation

Facility Name

Kidney Cancer Research Bureau

City

Moscow

Country

Russian Federation

Facility Name

Medicine 24/7 clinic

City

Moscow

Country

Russian Federation

Facility Name

Medscan

City

Moscow

Country

Russian Federation

Facility Name

Yauza clinical hospital

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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