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

Kidney Cancer Research Bureau

Status and phase: Completed; Phase 2

Conditions: Pleural Effusion, Malignant; Renal Cell Cancer Metastatic; Non-small Cell Lung Cancer Metastatic

Treatments: Drug: Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04749602

KCRB-Hadassah-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma

Experimental group

Description:

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Treatment:

Drug: Nivolumab

Cohort 2: Intrapleural Nivolumab in patients with non-small cell lung cancer

Experimental group

Description:

Drainage followed by nivolumab (40 mg, single intrapleural instillation) will be performed.

Treatment:

Drug: Nivolumab