BGOG-ov84/TroFuse-022

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1
Histology
Serous, Endometrioid Clear-cell Carcinocarcoma
Platin
Platinum sensitive
Phase
III
IMP
Sacituzumab tirumotecan
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

  • Sacituzumab tirumotecan +/- bevacizumab versus standard of care as maintenance therapy.

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC).
  • Has platinum-sensitive epithelial OC.

 

Main exclusion criteria:

  • Has platinum-resistant OC or platinum-refractory OC
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06824467). 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