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

NCT04749602 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-03-08

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Nivolumab

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

Sponsors & Collaborators

  • Kidney Cancer Research Bureau

    lead OTHER

Principal Investigators

  • Ilya Tsimafeyeu, M.D. · Kidney Cancer Research Bureau

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749602 on ClinicalTrials.gov