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NCT03597009 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Terminated
Registry status
Phase 1
Development phase
1
Enrollment target

NCT03597009: Clinical Trial Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT03597009 is a Phase 1 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03597009, a Phase 1 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study 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.

Primary Outcome

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 instrumen

Interventions

  • DRUG Nivolumab
  • DRUG Talimogene laherparepvec (TVEC)

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2019-03-06
Est. Completion 2020-02-12
Phase Phase 1

Why NCT03597009 stopped before completion

NCT03597009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT03597009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03597009 about?

NCT03597009 is a clinical study titled "A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion". 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.

What is the current status of trial NCT03597009?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2019-03-06. Estimated completion is 2020-02-12.

What interventions are being tested in trial NCT03597009?

The interventions under investigation include: Nivolumab (DRUG), Talimogene laherparepvec (TVEC) (DRUG).

Who is sponsoring clinical trial NCT03597009?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03597009's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03597009, the US trial registry maintained by the National Library of Medicine. NCT03597009 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.