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

NCT01161498 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-02-08

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Talimogene Laherparepvec

Administered by intratumoral injection

RADIATION

Radiation

70 grays of radiation administered in 35 fractions over 7 weeks

DRUG

Cisplatin

Administered by intravenous infusion

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • BioVex Limited

    lead INDUSTRY

Principal Investigators

  • Kevin Harrington, MD · Royal Marsden, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01161498 on ClinicalTrials.gov