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BGOG-ov56/DOVACC

A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients With Recurrent Ovarian Cancer

Open
Grade
High grade, Low grade
Prior lines
1, 2, 3
Histology
Serous, Endometrioid Clear-cell Mucinous Other (bv. mixed/rare)
Platin
Platinum sensitive
Phase
II
IMP
UV1, Olaparib, Durvalumab
principal investigator
Prof. Dr. Els Van Nieuwenhuysen

Treatment

This trial consists of three different treatment options:

  • Olaparib
  • Olaparib + Durvalumab
  • Olaparib + Durvalumab + UV1

Olaparib is taken orally twice daily. 
Durvalumab is administered intravenously once per month. 
UV1 is a vaccination administered 4 times in the first 10 days and once monthly in the subsequent 4 months.

Patients should be BRCAwt to be eligible for this trial.
Patients are assigned randomly (1:1:2) to one of the treatment groups.

Treatment duration

Olaparib is taken until disease progression, unacceptable toxicity or withdrawal of consent.
Durvalumab is administered for maximum 24 months or until disease progression, unacceptable toxicity or withdrawal of consent, whichever comes earlier.
UV1 is only administered in the first five months of the trial.
 

Eligibility

Main inclusion criteria:

  • Histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer, excluding mucinous or low-grade serous histology
  • Radiological or histological confirmation of relapse disease ≥ 6 months after penultimate chemotherapy
  • Patients who are non-gBRCAmut or tBRCAwt
  • Have completed at least two lines, but no more than 3 lines of chemotherapy, which means that patients at first or second relapse with treatment free interval of more than 6 months on penultimate chemotherapy are eligible.
    • Subjects must have completed at least 4 cycles of the last platinum-containing chemotherapy
  • Be either:
    • PARPi naive
    • Earlier treated with PARPi and not progressed during 6 months of PARPi therapy
  • Must not, in the opinion of the investigator, have progressed on, or after, latest platinum-containing chemotherapy. This means that patients with CR, PR, SD or no evidence of disease (NED) are eligible.
  • Must be included in the study within 10 weeks of completion of the final dose of platinum-containing chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Main exclusion criteria:

  • Previous immunotherapy (for example anti-PD-1/L1, including durvalumab)
  • Patients with myelodysplastin syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML
  • Concomitant treatment with bevacizumab within the last 3 weeks

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT04742075). 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

More information on this trial (NCT04742075)