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

Sponsor
Kidney Cancer Research Bureau
Study ID
NCT04749602
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    40 mg of the nivolumab will be used intrapleurally (once).

Study Details

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.

Key Dates

Start date
Aug 10, 2020
Status verified
Mar 2023
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma
    Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
  • Experimental: Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer
    Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Primary Outcome Measure

3-month recurrence-free survival [ Time Frame: 3 months ]

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