T-Vec with MK-3475 for Treatment of Stage IIIB to IVM1c Melanoma
Research type
Research Study
Full title
A Phase 1b/2, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With MK-3475 for Treatment of Previously Untreated, Unresected, Stage IIIB to IVM1c Melanoma
IRAS ID
159398
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2014-000185-22
Duration of Study in the UK
4 years, 2 months, 30 days
Research summary
Research Summary:
The purpose of this study is to find out more about talimogene laherparepvec in people with advanced melanoma when given in combination with MK-3475.The study will be conducted in 3 parts: Phase 1 of the study will see if talimogene laherparepvec in combination with MK-3475 is safe for people with advanced melanoma to take, Phase 2 Part 1 will see if talimogene laherparepvec in combination with MK-3475 is effective in people with advanced melanoma and Phase 2 Part 2 of the study will see if talimogene laherparepvec in combination with MK-3475 is effective in people with advanced melanoma after their cancer has worsened while they have received MK-3475 alone in Part 1 of Phase 2.
Subjects will be treated with talimogene laherparepvec in combination with MK-3475 or MK-3475 alone until 12 or 24 months from the date of the first dose of MK-3475 or until disappearance of injectable lesions, complete response, disease progression or intolerance of study treatment.
During Phase 1 and Phase 2 Part 1, subjects with a complete response who stop talimogene laherparepvec and MK-3475 or MK-3475 alone may be eligible for a second-course (retreatment) according to assigned treatment arm for up to 12 additional months of treatment at the investigator’s discretion if they experience subsequent disease progression.
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 for safety, antibodies and pharmacokinetics and to explore biomarkers.
Subjects will be followed for safety 30 days after the last dose of talimogene laherparepvec and for survival every 12 weeks for up to approximately 36 months after the last subject is enrolled in Phase 2.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1486
Date of REC Opinion
29 Oct 2014
REC opinion
Further Information Favourable Opinion