NCT03597009

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Pleural Effusion
• Stage IV Metastatic Cancer
• Lung Cancer

Interventions

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

Timeline

• Start date: 2019-03-06
• Primary completion: 2020-02-07
• Completion: 2020-02-12
• First posted: 2018-07-24
• Last updated: 2021-04-20
• Results posted: 2021-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study