Treatment
This trial consists of different options, depending on the patient's HLA-A2 status.
- HLA-A2 negative: follow-up of standard treatment and associated outcome
- HLA-A2 positive: randomization (1:1:2) to:
- Observation/best supportive care
- OSE2101
- OSE2101 + Pembrolizumab
OSE2101 is a vaccination administered one every three weeks (during the first 18 weeks), once every six weeks (the subsequent 30 weeks) or once every 12 weeks (from week 48 onward).
Pembrolizumab is administered intravenously once every six weeks.
Treatment duration
OSE2101 is administered until disease progression, unacceptable toxicity or withdrawal of consent.
Pembrolizumab is administered for maximum 24 months or until disease progression, unacceptable toxicity or withdrawal of consent, whichever comes earlier.
Eligibility
Main inclusion criteria:
- Histologically proven non-mucinous epithelial ovarian cancer
- ECOG Performance Status (PS) 0-1
- Clinical or radiological relapse of a platinum sensitive ovarian cancer regardless of the number of prior lines of platinum-based chemotherapy, as long as each prior line fulfilled the platinum sensitive criteria defined as complete response, partial response or stable disease according to RECIST 1.1 at the end of a platinum-based chemotherapy. Patient must have received at least 4 infusions of platinum during the last line of platinum-based chemotherapy
- Previously treated with a PARP inhibitor or not eligible to PARPi (i.e ineligibility due to not complete or partial response to chemotherapy)
- Prior therapy with bevacizumab or with contra-indication to bevacizumab (i.e arterial thromboembolic events, history of intestinal perforation, any other contra-indications according to the SmPC)
- Patient may have received prior immune checkpoint inhibitor (ICI), such as anti-PD-(L)1 or anti-CTLA-4 antibody and had a relapse after receiving the ICI without concomitant chemotherapy for at least 6 months (as treatment or maintenance)
- Randomization must be within 8 weeks of last dose of chemotherapy
Main exclusion criteria:
- Patient with contra-indications to immune therapies
- Use of any of the following immunomodulatory agents within 30 days prior to the first dose of study drug: Systemic corticosteroids (at dose higher than 10 mg/day equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start
- Prior cancer vaccine therapy
- Patient eligible for cytoreductive surgery at the time of inclusion
- Patient with clinical, radiological or biological progression (according GCIG criteria) at the end of last chemotherapy
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT04713514). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be