BGOG-ov85/TroFuse-021

A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
Frontline
Histology
Serous, Mucinous Endometrioid Clear-cell Carcinocarcoma
Phase
III
IMP
Sacituzumab Tirumotecan (sac-TMT)
principal investigator
Prof. Dr. Toon Van Gorp (ML)

Treatment

This study consists of two different treatment options:

  • Arm 1: sac-TMT +/- bevacizumab
  • Arm 2: Standard of Care (Observation or bevacizumab)

The treatment is given as maintenance therapy following first-line platinum-based chemotherapy.

Treatment duration

Up to 18 cycles of sac-TMT maintenance therapy is allowed. 

Eligibility

Main inclusion criteria:

  • Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
  • Has completed primary debulking surgery or interval debulking surgery.
  • Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.

Main exclusion criteria:

  • Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, or has current pneumonitis/ILD.

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT07318558). 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