BELLA

A Phase 2 Study of Relacorilant in Combination with Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer 

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1, 2
Histology
Serous, Endometrioid Clear-cell Carcinocarcoma
Platin
Platinum resistant
Secondary platinum refractory
Platinum sensitive
Primary platinum refractory
Phase
II
IMP
Relacorilant
principal investigator
Prof. Van Gorp/ER

Treatment

Study treatment will be comprised of relacorilant, combined with nab-paclitaxel

  • Nab-paclitaxel: intravenous, day 1, 8, 15 of each 28-day cycle
  • Relacorilant: oral administration

 

Treatment duration

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

Eligibility

Main inclusion criteria:

  • Stage III or IV, recurrent, or metastatic endometrial cancer
  • Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD[L]1) antibody
  • 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer

Main exclusion criteria:

  • Has progressed while receiving weekly paclitaxel or nab-paclitaxel
  • Bowel obstruction ≤12 weeks prior to study entry
  • Ascites or pleural effusions requiring therapeutic paracentesis

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06906341). 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