NCT03555032

TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion)

A Phase I/II Study of the Safety and Efficacy of Talimogene Laherparepvec (T-VEC) Delivered by Intra-tumoural Injection in Combination With Isolated Limb Perfusion With Melphalan and Tumour Necrosis Factor-α in Patients With Advanced Extremity Tumours Including Metastatic Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the safety and effects of combining a new drug called Talimogene Laherparepvec (T-VEC) with chemotherapy delivered by Isolated Limb Perfusion (ILP). The investigators want to find out whether these two treatments can be combined safely and whether T-VEC with ILP is better at treating your cancer than with ILP alone.

Detailed description

This is a non-randomised, single-centre Phase I/II study of the combination of the oncolytic virus, TVEC, administered by intra-tumoural (i.t.) injection in combination with isolated limb perfusion with melphalan and tumour necrosis factor in patients with advanced extremity tumours. The safety of T-VEC administered by i.t. injection followed by isolated limb perfusion will be assessed in an initial safety run in comprised of six subjects as described below. Cohort 1: The first subject will be recruited and will receive an initial dose of T-VEC 4-6 weeks prior to isolated limb perfusion. A further preoperative dose of i.t. T-VEC will be given at 2-3 weeks prior to isolated limb perfusion. A third dose will be given on the day of isolated limb perfusion. Following isolated limb perfusion, no further doses of TVEC shall be given. No further patients will be recruited until this patient has passed 30 days from the end of the study treatment. If this patient experiences a dose limiting toxicity (DLT), the Trial Steering Committee (TSC) will meet to consider termination of the study. Cohort 2: Assuming no DLTs in Cohort 1, two further patients will be recruited and receive the study treatment as described above. Once these patients have passed 30 days from the end of the study treatment, the TSC will meet and perform a safety assessment. Cohort 3: Assuming TSC approval following Cohort 2, three further patients will be recruited and receive the study treatment as described above. Once these patients have passed 30 days from the end of the study treatment, the TSC will meet and perform a safety assessment. Cohort 4: Open recruitment up to a maximum of 15 patients in total, unless otherwise indicated by the TSC. If more than 1 DLT is observed at any point in the study, the Chief Investigator will notify the TSC and recruitment will be suspended until further notification from the TSC.

Conditions

• Melanoma and Sarcoma

Interventions

Type	Name	Description
DRUG	Talimogene laherparepvec (T-VEC)	One dose of 1 x 106 PFU/mL. Two doses of 1 x 108 PFU/mL. Given by intra-tumoural (i.t.) injection.

Timeline

• Start date: 2018-06-26
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2018-06-13
• Last updated: 2021-08-18

Locations

1 site across 1 country: United Kingdom