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
Prior lines
1, 2, 3
Histology
Serous, Endometrioid
Platin
Platinum resistant
Secondary platinum refractory
Phase
II
IMP
Relacorilant
principal investigator
Prof. Van Gorp/ER

Treatment

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

  • Nab-paclitaxel: intravenous, day 1, 8, 15 of each 28-day cycle
  • Bevacizumab: intravenous, day 1, 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:

  • Histologic diagnosis of high-grade serous/endometrioid, epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma
  • Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor
  • 1 to 3 lines of prior systemic anticancer therapy for ovarian cancer

Main exclusion criteria:

  • Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic
  • 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