Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Pleural Effusion

Neoplasm Metastasis

Lung Neoplasms

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Talimogene laherparepvec

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab

Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab

Talimogene laherparepvec (TVEC)

Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort

Jared Weiss, MD

This is a Phase Ib/II clinical trial to evaluate the feasibility of administering talimogene laherparepvec into the intrapleural space of subjects with malignant pleural effusion through a pleurX catheter.

This is a phase 1b/II clinical trial that includes a safety run-in cohort to investigate the novel approach of administering intrapleural talimogene laherparepvec via a pleurX catheter in patients with known malignant pleural effusion (MPE).

In Phase Ib of this study, the safety of infusing talimogene laherparepvec directly into the pleural cavity of subjects diagnosed with MPE, through pleurX catheter, will be tested.

In Phase II of this study, after establishing the safety of the above mentioned approach, 24 subjects will enrolled and treated with intrapleural talimogene laherparepvec and IV nivolumab.

We will conduct a Phase Ib/II trial that includes a safety run-in period using 3 +3 dose escalation rules to evaluate the feasibility of administering talimogene laherparepvec into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter.

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

A Phase Ib/II Study of IV Nivolumab and Intrapleural Talimogene Laherparepvec for Patients With Malignant Pleural Effusion

Number of participants with treatment-related adverse events as assessed by the NCI Common Terminology Criteria for Adverse Events which is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

The rate of resolution of malignant pleural effusion following IV nivolumab combined with intrapleural injection of talimogene laherparepvec

Progression free survival from day 1 of treatment until death or progression. Per immune-related Response Evaluation Criteria in Solid Tumours (irRECIST), immune-related Progressive Disease (irPD)is defined as at least 20% and minimum 5 mm absolute increase in total measured tumor burden compared to nadir, or irPD for non-target or new un-measurable lesions.

Overall survival from day 1 of treatment until death

Response rate after treatment per Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) defined as the proportion of patients with reduction in tumor (immune-related Complete Response (irCR) or immune-related Partial Response (irPR)). irCR is a complete disappearance of all lesions (whether measurable or not) and no new lesions. Lymph nodes must decrease to \<10mm in short axis. irPR is a decrease in tumor burden ≥ 30%, in total measured tumor burden relative to baseline, non-target lesions are not in complete response (disappearance of all lesions) and not unequivocal progression or new non-measurable lesions.

Results from patient reports of the Modified Borg Scale of Perceived Dyspnea, measuring change in scale over time. The scale evaluates perceived level of shortness of breath ranging from 0 to 10, where 0 indicates the greatest success of the treatment.

CareFusion

Amgen

UNC Lineberger Comprehensive Cancer Center

Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab

Talimogene laherparepvec (TVEC): Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab

Nivolumab: Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort

Open-label, Single-arm Phase I

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study terminated early due to slow accrual and withdrawal of funding so only one participant was enrolled.

Robin Johnson

Phase I Number of Participants With Treatment-related Adverse Events

No participants were enrolled on the Phase II portion of the study

Phase II Resolution of MPE

Median Progression Free Survival

Overall Survival

Response Rate

No participants were enrolled in the Phase II portion of the study

Phase II Number of Participants With Treatment-related Adverse Events

Average Dyspnea Score

Overall Study

Patients in whom we use VATS-surgical pleurodesis for malignant pleural effusion.

Patients in whom we use tube drainage for malignant pleural effusion.

VATS-Surgical pleurodesis

Tube drainage for malignant pleural effusion

Tube Drainage

Kareem A Hosny, M.SC

Kareem Ahmed Hosny, Bachelor of medicine

Malignant Pleural Effusion (MPE) is considered to be a common presentation at malignant tumors representing 15% of all cancer cases. It carries a burden on our patients with dyspnea being the most common symptom in most of cases.

Management of symptomatic malignant pleural effusion remains to be a point of debate. Data available from literature shows conflicting results lacking high quality evidence which necsscitates further research work. Options differs to include chemical pleurodesis using medical or surgical talc poudrage or slurry. Surgical intervention with abrasion pleurodesis or pleurectomy using VATS approach has been used in many studies. Using indwelling pleural catheters (IPCs) has also proved comparable efficacy at many clinical trials. In this study we want to help answering this question so that we can add to the current knowledge aiming to offer the best care for those patients

Randomised Clinical Trial with 2 groups; Case group for VATS mechanical abrasion and Control group for tube drainage

Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)

patient reported outcome through a pre-prepared questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion	NCT03597009	Malignant Pleur... Stage IV Metast... Lung Cancer	Talimogene lahe... Nivolumab	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
Video Assisted Thoracoscopic Surgery (VATS) - Surgical Pleurodesis vs Tube Drainage in Management of Malignant Pleural Effusion (MPE)	NCT05872126	Malignant Pleur... Thoracic Cancer	VATS-Surgical p... Tube Drainage	5 Years - 90 Years	Assiut University

Spots Global Cancer Trial Database for pleurx

Every month we try and update this database with for pleurx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pleurx

Every month we try and update this database with for pleurx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pleurx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.