Home Clinical trials For patients Ovary BGOG-ov58/TEDOVA

BGOG-ov56/TEDOVA

Randomized Phase II Study Comparing Neo-epitope Based Vaccine OSE2101 (TEDOPI®) With or Without Anti-PD1 (Pembrolizumab) Versus Best Supportive Care as Maintenance Treatment in Platinum-sensitive Recurrent Ovarian Cancer Patient With Controlled Disease After Platinum-based Chemotherapy

Open
Trial drug
OSE21001, Pembrolizumab
Grade
High grade, Low grade
Prior lines
1, 2, 3, 4, >4
Histology
Serous, Endometrioid Clear-cell Other (bv. mixed/rare)
Platin
Platinum sensitive
Phase
II

Treatment

This study consists of three different treatment options, depending on a test performed on your tumor tissue and a blood sample: 

  • In case you do not have the protein with which the study product reacts you will be followed within the scope of this trial while you receive a standard treatment or follow-up
  • In case you have the protein with which the study product reacts, three different groups are available. You will be randomly allocated to one of the treatment groups.:
    • Follow-up (without treatment)
    • OSE2101
    • OSE2101 + Pembrolizumab

OSE2101 is a vaccination administered once every three weeks (for the first 18 weeks), once per 6 weeks (for the next 30 weeks) or once every 12 weeks (after week 48). 
Pembrolizumab is administered intravenously every 6 weeks.

Treatment duration

The treatment with OSE2101 can continue until disease progression, unacceptable toxicities or until you decide to stop.
The treatment with Pembrolizumab can continue for maximum 24 months. The treatment will be stopped earlier in case of disease progression, unacceptable toxicity or in case you decide to stop.

Contact

To be able to give you the best information and care we do not give medical advice via mail. We kindly ask you to make an appointment via lgog@uzleuven.be.