A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

Protocol No

We will compare the two treatment regimens in people with ovarian cancer and see
which one slows tumor growth faster or better, and which one is safer (causes fewer problems).
Relacorilant + nab-paclitaxel is still experimental and is not approved by the U.S. Food and
Drug Administration. This combination of drugs may have advantages over routine treatments
for ovarian cancer, but we won’t know until we do more research studies.
We don’t know if this study will help you. Your condition may get better, but it could stay the
same or even get worse. We hope the information from this study will help us develop a better
treatment for ovarian cancer in the future.

The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
Participating Institutions
Froedtert Hospital