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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
40 mg of the nivolumab will be used intrapleurally (once).
I.M. Sechenov First Moscow State Medical University
Moscow, Russia
Kidney Cancer Research Bureau
Moscow, Russia
Medicine 24/7 clinic
Moscow, Russia
Medscan
Moscow, Russia
Yauza clinical hospital
Moscow, Russia
3-month recurrence-free survival
Proportion of patients who will be without signs of radiographic recurrence after 3 months
Time frame: 3 months
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
Time frame: 3 months
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