TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion) (NCT03555032) | Clinical Trial Compass
CompletedPhase 1/2
TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion)
United Kingdom15 participantsStarted 2018-06-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females aged 18 years.
✓. A confirmed histological diagnosis of in-transit malignant melanoma with or without regional lymph node metastases or limited visceral metastatic disease (AJCC Stage IIIb/c and IVa/b) or locally advanced soft-tissue sarcoma with or without regional or distant metastases (T2a/b, N0/1, M0/1) suitable for isolated limb perfusion.
✓. Life expectancy of at least 3 months (as assessed, and documented by the Chief Investigator).
✓. ECOG Performance Score of 0 to 2.
✓. No continuing acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) Grade 1.
✓. Completed any previous chemotherapy at least 28 days before entry into the study.
✓. Have baseline laboratory results as follows:
✓. Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable
Exclusion criteria
✕. Known cerebral metastases.
✕. Have had concurrent immunotherapy during, and for the number of days equal to the half-life of that agent before or during, the study therapy.
✕. Evidence of immunosuppression for any reason:
What they're measuring
1
The number of dose limiting toxicities and adverse events when T-VEC administered by intratumoural injection is combined with Isolated Limb Perfusion [Safety and Tolerability]
Timeframe: From first T-Vec administration to 52 week follow up.
2
The percentage of patients achieving complete/partial response following treatment [Efficacy]
Timeframe: From T-Vec and ILP administration until 52 weeks follow up.
✕. A history of hypersensitivity to T-VEC or its excipients.
✕. Pregnant or breast-feeding female. Confirmation that women of childbearing potential are not pregnant with a negative serum and urine beta-human chorionic gonadotrophin (beta-hCG) pregnancy test results must be obtained within 7 days prior to treatment initiation (i.e. the 1st administration of T-VEC).
✕. Fertile males and females who are unwilling to employ highly effective means of contraception during study treatment and for 3 months after the last dose of study treatment.
✕. Previous treatment with T-VEC for active disease.