T-Vec in combination with Pembrolizumab in recurrent/metastatic SCCHN
Research type
Research Study
Full title
A Phase 1b/3 Multicenter, Randomized, Open-label Trial of Talimogene Laherparepvec in combination with Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
IRAS ID
190817
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2015-003011-38
Duration of Study in the UK
5 years, 10 months, 24 days
Research summary
The purpose of this study is to evaluate the safety and efficacy of talimogene laherparepvec in combination with pembrolizumab in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The study will be conducted in 2 parts (phase 1b and phase 3). In phase 1b talimogene laherparepvec will be administered in combination with pembrolizumab to subjects with recurrent or metastatic SCCHN to evaluate the safety and efficacy of the combination treatment. Phase 3 is a multicenter, open-label, randomized study to evaluate the efficacy, as assessed by progression free survival and overall survival, of treatment with talimogene laherparepvec in combination with pembrolizumab, as compared to pembrolizumab alone in subjects with recurrent or metastatic SCCHN. In Phase 3 subjects will receive either talimogene laherparepvec plus pembrolizumab or pembrolizumab alone. Treatment will continue until disappearance of injectable lesions, disease progression, intolerance of study treatment, or up to 24 months.
Radiographic imaging and tumour assessments will be performed throughout the study to assess the tumour response. Blood samples will also be collected during the study and analysed for safety, antibodies and pharmacokinetics and to explore biomarkers.
All subjects will complete a safety follow-up visit approximately 30 days after the last dose of study treatment, after which all subjects will enter the long-term follow-up. Subjects will be followed for survival, subsequent anticancer therapies and talimogene laherparepvec related adverse events every 12 weeks for approximately 36 months after the last subject is enrolled in phase 3.
Subjects who have received talimogene laherparepvec and completed the
protocol-specified follow-up period will be eligible to continue follow-up in a separate ongoing registry protocol which is in place for the long-term survival follow-up of subjects treated with talimogene laherparepvec in clinical trials.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0013
Date of REC Opinion
29 Feb 2016
REC opinion
Further Information Favourable Opinion