NCT01161498

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

A Phase 3 Randomized Trial of Concurrent Cisplatin & Radiotherapy With Or Without ONCOVEX^GM-CSF In Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: BioVex Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective is to evaluate the efficacy and safety of treatment with chemoradiation (CRT) plus talimogene laherparepvec compared to CRT alone in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) for which surgical resection is not clinical indicated. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to CRT alone.

Conditions

• Squamous Cell Carcinoma
• Head and Neck Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-07-13
• Last updated: 2016-02-08
• Results posted: 2015-12-17

Locations

6 sites across 2 countries: United States, United Kingdom