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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03597009
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2019
Status verified
Mar 2021
Primary completion
Feb 7, 2020
Completion
Feb 12, 2020

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label, single-arm Phase I
    Talimogene laherparepvec (TVEC) administered into the intrapleural space of subjects with malignant pleural effusion (MPE) via a pleurX catheter with or without nivolumab

Primary Outcome Measure

Phase I Number of Participants With Treatment-related Adverse Events [ Time Frame: from day 1 of treatment to 30 days after the last dose of study medication (approximately 11 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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