Clinical trial · Interventional
Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
A Phase II Trial of Intrapleural Instillation of the Nivolumab in Cancer Patients With Pleural Effusion.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
| Renal Cell Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma
- description
- Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
- interventionNames
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer
- description
- Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- 3-month recurrence-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available