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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma | Experimental | Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. |
|
| Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer | Experimental | Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | 40 mg of the nivolumab will be used intrapleurally (once). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-month recurrence-free survival | Proportion of patients who will be without signs of radiographic recurrence after 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilya Tsimafeyeu, M.D. | Kidney Cancer Research Bureau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University | Moscow | Russia | ||||
| Kidney Cancer Research Bureau |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)
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|
| Moscow |
| Russia |
| Medicine 24/7 clinic | Moscow | Russia |
| Medscan | Moscow | Russia |
| Yauza clinical hospital | Moscow | Russia |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |