Long-term Extension for GEN701 and GEN702
Research type
Research Study
Full title
A Multi-Center, Open-Label Trial Investigating the Efficacy and Safety of Continued Treatment with Tisotumab Vedotin in Patients with Solid Tumors Known to Express Tissue Factor
IRAS ID
222308
Contact name
Johann S de Bono
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2016-004743-37
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is an open-label, multi-centre study to collect long-term safety and efficacy data and to provide ongoing access to tisotumab vedotin for patients with solid cancer tumours who have completed a tisotumab vedotin base study.
The tumours treated in this study are known to express a special protein (one of the building blocks of the body) on the surface of their tumour cells. This protein is called tissue factor. The study medication combines an antibody (a protein that selectively identifies and neutralises foreign substances) with a chemotherapeutic agent (a medication that kills tumour cells). Thereby the tumour cells can be selectively targeted, in that the antibody binds to the tissue factor on the tumour cells, delivers the chemotherapeutic agent and kills the tumour cells.Participants will be treated with the tisotumab vedotin dosing regimen followed by the participant in the base study. This will be through an intravenous infusion (medication administered through a vein in the arm) on either of the below treatment schemes:
•Day 1 of each 21-day cycle (once every three weeks)
•Or on Day 1, Day 8 and Day 15 of each 28-day cycle (three times every four weeks)Each participant’s dose will be calculated based on the participant’s weight. The intravenous administration will take between 30 minutes and 4 hours. Other study procedures include: medical history, vital signs, height and weight measurements, CT scans, blood pregnancy tests, skin and neuropathy toxicity assessments, bone scans (depending on the participant’s disease), blood test for cancer antibody 125 (dependent on disease) and ECGs.
Approximately 25 male and female participants aged 18 years and older will enter the study in research sites across the UK, Denmark and the US.
The study will continue until Marketing Authorisation is granted in the UK or the sponsor stops developing tisotumab vedotin.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0128
Date of REC Opinion
16 May 2017
REC opinion
Further Information Favourable Opinion