Trial reportGynecologic oncology2026
A phase II study of androgen receptor inhibition by darolutamide in combination with leuprolide acetate and exemestane in recurrent adult-type ovarian granulosa cell tumor.
Trial report in Gynecologic oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06169124 (A Phase II Study of Androgen Receptor), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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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
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Authors and funding
13 authors.
Funding
Abstract
objectiveTo determine the efficacy and safety of darolutamide, exemestane, and leuprolide acetate in recurrent adult-type ovarian granulosa cell tumor (AGCT).
methodsThis single-arm Phase II cooperative group study included patients with recurrent AGCT who had progressed on a prior aromatase inhibitor. The treatment regimen consisted of darolutamide 600 mg by mouth twice daily, exemestane 25 mg by mouth once daily, and leuprolide acetate 7.5 mg by intramuscular injection every four weeks. Patient accrual occurred from January 2024 to April 2024 with sample size determined using Simon's Optimal two-stage design. The primary measure of efficacy was objective response rate (ORR) measured by Response Evaluation Criteria in Solid Tumors 1.1. Secondary objectives included duration of response, progression-free survival (PFS), overall survival (OS), and safety of the treatment regimen.
resultsSeventeen patients were enrolled to complete target accrual of the first stage. Of the 16 evaluable patients, there was one partial response (ORR = 6.25%). The trial did not continue to the second stage as it did not meet its prespecified endpoint. Ten patients (62.5%) were confirmed to have stable disease and five patients (31.25%) were confirmed to have progressive disease. Median PFS was 8.5 months (95% CI: 3.1 months - 12.0 months). Median OS was not reached. There were no grade 4 or grade 5 adverse events attributable to the treatment regimen.
conclusionsThough the trial did not meet its primary endpoint, there was one partial response to the treatment regimen. Clinically meaningful PFS was demonstrated. Clinical Trial Registration Number NCT06169124.
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