BGOG-ov89/DESTINY-Ovarian01

A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer

Open
Grade
High grade
Prior lines
Frontline
Histology
Serous, Mucinous Endometrioid Clear-cell Carcinocarcoma
Phase
III
IMP
Trastuzumab Deruxtecan
principal investigator
Prof. Dr. Els Van Nieuwenhuysen

Treatment

This study consists of two different treatment options:

  • Trastuzumab Deruxtecan + bevacizumab
  • Bevacizumab

The treatment is given every 3 weeks as first-line maintenance therapy. 

Treatment duration

Up to 16 cycles of maintenance therapy is allowed.

Eligibility

Main inclusion criteria:

  • Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
  • Is newly diagnosed FIGO Stage III or IV.
  • Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring by central testing
  • Has received standard of care bevacizumab in combination with front line platinum based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion

Main exclusion criteria:

  • Has a BRCA mutation as per local test.
  • Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06819007). 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