Non-small Cell Lung Cancer Metastatic Clinical Trial
Official title:
A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
Verified date | March 2023 |
Source | Kidney Cancer Research Bureau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | I.M. Sechenov First Moscow State Medical University | Moscow | |
Russian Federation | Kidney Cancer Research Bureau | Moscow | |
Russian Federation | Medicine 24/7 clinic | Moscow | |
Russian Federation | Medscan | Moscow | |
Russian Federation | Yauza clinical hospital | Moscow |
Lead Sponsor | Collaborator |
---|---|
Kidney Cancer Research Bureau |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-month recurrence-free survival | Proportion of patients who will be without signs of radiographic recurrence after 3 months | 3 months | |
Secondary | 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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