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NCT01161498 · ClinicalTrials.gov registry record · Phase 3

Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer

A Phase 3 study, sponsored by BioVex Limited.

Terminated
Registry status
Phase 3
Development phase
5
Enrollment target

NCT01161498: Clinical Trial Phase 3 study, sponsored by BioVex Limited.

NCT01161498 is a Phase 3 study that was terminated before completion, run by BioVex Limited. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01161498, a Phase 3 study, was terminated before completion, sponsored by BioVex Limited.

TERMINATED
Registry status
Phase 3
Development phase
5 participants
Enrollment target

Study Summary

This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide information on the usefulness of talimogene laherparepvec combined with chemoradiation as a future treatment for head and neck cancer.

Primary Outcome

Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.

Interventions

  • DRUG Cisplatin
  • RADIATION Radiation
  • BIOLOGICAL Talimogene Laherparepvec

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2011-02
Est. Completion 2011-10
Phase Phase 3
BioVex Limited

5 total trials

Why NCT01161498 stopped before completion

NCT01161498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.

NCT01161498 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01161498 about?

NCT01161498 is a clinical study titled "Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer". This study is being conducted to learn about the safety and risks of using talimogene laherparepvec to treat patients with head and neck cancer and to see if talimogene laherparepvec and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide in...

What is the current status of trial NCT01161498?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2011-02. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01161498?

The interventions under investigation include: Cisplatin (DRUG), Radiation (RADIATION), Talimogene Laherparepvec (BIOLOGICAL).

Who is sponsoring clinical trial NCT01161498?

This trial is sponsored by BioVex Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01161498's enrollment target sits among peer trials

5 1997th of 2000 higher than 3 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01161498, the US trial registry maintained by the National Library of Medicine. NCT01161498 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.