Biomarker Study with T-Vec in Unresected Stage IIIB to IVM1c Melanoma
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated with Talimogene Laherparepvec
IRAS ID
158013
Contact name
Sophie Papa
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2013-005552-15
Research summary
The purpose of this study is to evaluate biomarkers in subjects with unresected stage IIIB to IVM1c melanoma who are treated with talimogene laherparepvec.
All subjects will be treated with talimogene laherparepvec until the subject has achieved a complete response, all injectable tumours have disappeared, clinically significant disease progression beyond 6 months of treatment, or intolerance of study treatment, whichever occurs first.
Radiographic imaging assessments and clinical tumour measurements will be performed throughout the study to assess the tumour response. Blood and tumour tissue samples will be collected during the study and samples analysed to explore if the biomarker level at baseline and its change during treatment is correlated with the response rate in subjects.
Subjects will be followed for safety after the last dose of talimogene laherparepvec and for survival every 12 weeks for up to approximately 24 months after the last subject is enrolled.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1426
Date of REC Opinion
20 Oct 2014
REC opinion
Further Information Favourable Opinion