Study of Talimogene Laherparepvec with Pembrolizumab in Melanoma
Research type
Research Study
Full title
Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti-PD-1 Based Therapy
IRAS ID
270670
Contact name
Sophie Papa
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2019-001906-61
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 15 days
Research summary
Anti-programmed cell death-1 (PD-1) therapies, pembrolizumab and nivolumab, are
currently considered the standard of care for advanced melanoma in the first line
metastatic setting. For patients who fail anti-PD-1 therapy, treatment options are limited in advanced melanoma following disease progression during or after anti-PD-1 therapy, thus it is considered an unmet medical need. Additionally, with the recent availability of checkpoint inhibitors in the adjuvant setting, it remains to be understood how patients will be treated upon progression to metastatic disease.
This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec (T-VEC) in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting.
Subject must have received prior anti-PD-1 therapy for at least 2 to 3 consecutive cycles within an 8-week period (based on administration schedule) and have disease
progression. Approximately 100 subjects will be enrolled into 1 of 4 cohorts based on prior anti-PD-1 experience:
Cohort 1 – Locally Recurrent/Metastatic - Primary Resistance
Cohort 2 – Locally Recurrent/Metastatic - Acquired Resistance
Cohort 3 – Adjuvant Setting – Disease Free Interval < 6 months
Cohort 4 – Adjuvant Setting – Disease Free Interval ≥ 6 months
T-VEC and pembrolizumab are administered at a once every 3 weeks (Q3W) frequency.
Previous studies have shown that the combination of T-VEC and pembrolizumab changed the tumor microenvironment by increasing the CD8+ T cell infiltration. This study is intended to provide additional clinical data to support the combination of
T-VEC and pembrolizumab in patients with unresectable/metastatic IIIB-IVM1d melanoma who have progressed after receiving a checkpoint inhibitor.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1942
Date of REC Opinion
24 Apr 2020
REC opinion
Further Information Favourable Opinion