NRG Activates Phase II Study for AR-Positive Ovarian Granulosa Cell Tumors (NRG-GY033)

February 12 2024

NRG-GY033: A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination with Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumor

The NRG-GY033 clinical study activated to patient enrollment in January 2024. This trial will be accruing patients with recurrent ovarian granulosa cell tumors (AGCT) who have progressed on an aromatase inhibitor in a prior line of therapy. Trial participants will receive the drugs darolutamide, leuprolide acetate, and exemestane until disease progresses. The primary objective of this study is to determine the objective response rate of the patients receiving this drug combination.

“Since this is such a rare disease type, there is currently a lack of prospective trials available to provide the best, evidence-based treatment plan for patients with recurrent disease and there are limited treatment options available,” stated Elizabeth Hopp, MD, a Gynecologic Oncologist at the Medical College of Wisconsin and the Principal Investigator of the NRG-GY033 clinical trial. “NRG-GY033 was designed to address the need for a tolerable therapy that produces a measurable response in this patient population.”

Currently, chemotherapy with carboplatin/paclitaxel is the preferred treatment regimen for recurrent disease, but this is because of a lack of data available for a better alternative option in this specific population. Chemotherapy for women with AGCT typically incurs potential toxicities and lower response rates. Hormonal therapy is usually well-received by patients with recurrent disease and is a viable option for patients with AGCT based on tumor expression of hormonal receptors. The combination of darolutamide, leuprolide acetate, and exemestane was specifically selected for this trial in an effort to allow for a hormonal blockade and potential tumor response for AGCT patients.

Secondary objectives of NRG-GY033 include determining the duration of response, progression free survival, overall survival, and toxicities of the drug combination used on this study. An exploratory objective of the trial is to reveal biomarkers that are predictive of response to this drug combination.

Protocol documents and materials are located on the CTSU website

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