innovaTV 205
Research type
Research Study
Full title
A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC_ in combination with Other Agents in Subjects with Recurrent or Stage IVB Cervical Cancer
IRAS ID
255753
Contact name
Susana Banerjee
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2017-004758-40
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The purpose of this trial is to investigate the tolerability of the drug tisotumab vedotin in combination with either pembrolizumab, carboplatin or bevacizumab in patients with cervical cancer. The results of this trial will help in determine the maximum tolerated dose and recommended dose of the trial drugs.
Tisotumab vedotin is an investigational drug and has not been approved for sale in the UK. However it has been tested in humans previously, and has shown to be potentially effective and tolerable. Pembrolizumab, carboplatin and bevacizumab have been approved by the regulatory authority in the UK for the treatment of cervical cancer.
This trial will be conducted in 2 parts; dose escalation followed by dose expansion.
The trial will be a global, multi-center trial which anticipates to enrol approximately 50 patients in the dose escalation phase and approximately 90 patients in the dose expansion phase, with a total of 140 patients in the trial. The ideal patient population will be women over the age of 18 with cervical cancer, there is no upper age limit in this study.The study drug will be used in combination with each of the drugs mentioned above, in 3 different arms. the totality of data observed from the combinations will be used to inform future combinations.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/2102
Date of REC Opinion
31 Aug 2019
REC opinion
Further Information Favourable Opinion