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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion

NCT03597009

Malignant Pleural Effusion Stage IV Metastatic Cancer Lung Cancer

TERMINATED PHASE1/PHASE2

Ph I:Bevacizumab + Chemotherapy in Pts w/Malig Pleural Effusion Due to Adv NSCLC

NCT00250978

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE1

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

NCT02538666

Lung Cancer

COMPLETED PHASE3

A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT02574078

Non-Small Cell Lung Cancer

COMPLETED PHASE1/PHASE2

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT02477826

Non-Small Cell Lung Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cohort 1 (renal cell carcinoma / lung cancer) Cohort 2 (lung cancer)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: Intrapleural Nivolumab in patients with renal cell carcinoma

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

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

40 mg of the nivolumab will be used intrapleurally (once).

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

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

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

40 mg of the nivolumab will be used intrapleurally (once).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nivolumab

40 mg of the nivolumab will be used intrapleurally (once).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Opdivo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)