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Adult Ovarian Granulosa Cell TumorPhase 2NCT06169124

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

A Phase 2 study testing Biospecimen Collection, Chest Radiography and Computed Tomography in people with Adult Ovarian Granulosa Cell Tumor, run by National Cancer Institute (NCI) at 66 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell tumors that have come back after a period of improvement (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Adult Ovarian Granulosa Cell Tumor
What is being tested?
Biospecimen Collection, Chest Radiography and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
66 sitesUnited States
Study dates
8 Feb 2024to 28 Sep 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Physicians should consider the following when evaluating if the patient is appropriate for this protocol:
  • Patients must have adequate health that permits completion of the study requirements and required follow up
  • For patients with known human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection:
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Show all 27Show fewer
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • In addition:
  • The effects of the combination of darolutamide, leuprolide acetate, and exemestane on the developing human fetus are unknown. For this reason, and because androgen receptor inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 1 month following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately
  • Submission of tissue is required. Investigators should check with their pathology department regarding release of tissue before approaching patients about participation in the trial
  • Histologically confirmed diagnosis of recurrent adult-type granulosa cell tumor
  • Patient must have measurable disease. Measurable disease is defined in the protocol per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
  • Patient must have had ≥1 treatment regimen
  • Subject must have progressed on an aromatase inhibitor (letrozole, exemestane, anastrozole) in a prior treatment line
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Not pregnant and not nursing
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 8 g/dl
  • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • No active infection requiring parenteral antibiotics
  • Patients with current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Who cannot join

  • Prior treatment with AR inhibitors
  • Known hypersensitivity to the study drugs or their ingredients

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Community Medical Center

    Missoula, Montana, 59804

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: 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

This phase II trial tests how well darolutamide in combination with leuprolide acetate and exemestane works in treating patients with ovarian granulosa cell tumors that have come back after a period of improvement (recurrent). Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Leuprolide acetate is in a class of medications called gonadotropin-releasing hormone agonists. It works by decreasing the amount of certain hormones in the body. Exemestane is in a class of medications called aromatase inhibitors which has anti-estrogen and anticancer activities. Exemestane binds to and inhibits the enzyme aromatase, thereby blocking the conversion of androgens to estrogens. This lowers estrogen levels in the blood circulation causing the tumor cells to grow more slowly or stop growing completely. The combination of darolutamide, leuprolide acetate, and exemestane may be an effective approach to shrinking or stabilizing recurrent ovarian granulosa cell tumors or preventing them from coming back.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the objective response rate of darolutamide, leuprolide acetate, and exemestane in recurrent adult-type granulosa cell tumors of the ovary (AGCT).

SECONDARY OBJECTIVES:

  1. To determine duration of response of darolutamide, leuprolide acetate, and exemestane in recurrent adult-type granulosa cell tumors of the ovary (AGCT).

II. To determine progression-free survival of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

III. To determine overall survival of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

IV. To elucidate the toxicities of darolutamide, leuprolide acetate, and exemestane when used in recurrent adult-type granulosa cell tumors of ovary (AGCT).

EXPLORATORY OBJECTIVE:

  1. To determine biomarkers predictive of response to darolutamide, leuprolide acetate, and exemestane.

OUTLINE:

Patients receive exemestane orally (PO) once daily (QD) and darolutamide PO twice daily (BID) starting on days -14 to -7 prior to cycle 1, day 1 (C1D1) and then on days 1-28 of each cycle. Patients receive leuprolide acetate intramuscularly (IM) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo chest computed tomography (CT) or chest x-ray and CT, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT as well as blood sample collection throughout the study. Patients undergo collection of archived tissue during screening.

Upon completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Biospecimen Collection, Chest Radiography, Computed Tomography, Darolutamide, Exemestane
Medical subject headings
Granulosa cell tumor of the ovary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo archived tissue and blood sample collection

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT and/or PET/CT

  • DarolutamideDrug

    Also called Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788

    Given PO

  • ExemestaneDrug

    Also called Aromasin, FCE-24304

    Given PO

  • Leuprolide AcetateDrug

    Also called A 43818, A-43818, A43818, Abbott 43818

    Given IM

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT06169124
Study groupRoleWhat they receive
Treatment (exemestane, darolutamide, leuprolide acetate)ExperimentalPatients receive exemestane PO QD and darolutamide PO BID starting on days -14 to -7 prior to C1D1 and then on days 1-28 of each cycle. Patients receive leuprolide acetate IM on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo chest CT or chest x-ray and CT, MRI, or PET/CT as well as blood sample collection throughout the study. Patients undergo collection of archived tissue during screening.
Receives: Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Computed Tomography; Drug: Darolutamide; Drug: Exemestane; Drug: Leuprolide Acetate; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Defined as a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report.

    Measured: Within 9 months of initiating study treatment

Secondary outcomes (4)

  1. Duration of Response

    The duration of overall response is measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that recurrence or progressive disease is objectively documented. Only one patient experienced a partial response (PR) within the 9-month response window. Therefore the 95% confidence interval for the duration of response was not estimated.

    Measured: Within 9 months of initiating study treatment

  2. Progression-free Survival (PFS)

    Progression-free survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact with known progression-free status if neither progression nor death has occurred. Patients with no follow-up will be censored 1 day after enrollment. Will be graphed using Kaplan-Meier methods. Median PFS will be estimated with corresponding 95% confidence intervals.

    Measured: up to 22 months

  3. Overall Survival (OS)

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. Patients with no follow-up will be censored 1 day after enrollment. Will be graphed using Kaplan-Meier methods. Median OS will be estimated with corresponding 95% confidence intervals.

    The OS was not reached due to the study early termination for futility. Thus the death rate was reported instead of survival time.

    Measured: up to 22 months

  4. Incidence of Adverse Events

    Common Terminology Criteria for Adverse Events version 5 will be used to grade and categorize adverse events. Safety will be assessed beginning with the initial dose of any treatment. Descriptive statistics, including frequencies of maximum grade of adverse events by term and category will be reported. Adverse events categorized as grade 5 will be individually reported.

    Measured: Adverse Events were assessed up to 9 months, All Cause Mortality was assessed up to 22 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start8 Feb 2024
  3. Primary completion10 Feb 2026
  4. Study completion28 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06169124
Sponsor's protocol ID
NCI-2023-06524
Other IDs
NCI-2023-06524, NRG-GY033, NRG-GY033, U10CA180868
Status last verified
Oct 2026
First submitted
7 Dec 2023
Last updated
3 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Hopp EE, Enserro D, Campos S, Chitiyo V, Huang G, Lankes H, Crane EK, Hoekstra A, Siedel J, Richardson DL, Aghajanian C, Rader JS, Covens A. 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. Gynecol Oncol. 2026 Aug 10;212:98-105. doi: 10.1016/j.ygyno.2026.07.017. Online ahead of print.

    PubMed 42574969

  • Erfani H, Martynova A, Matsuzaki S, Matsuo K, Roman LD, Sood AK, Kurnit KC, Westin SN. Androgen receptor as a therapeutic target in endometrial cancer: a narrative review. Int J Gynecol Cancer. 2026 Jun;36(6):104698. doi: 10.1016/j.ijgc.2026.104698. Epub 2026 Apr 11.

    PubMed 42070324

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Chest Radiography and Computed Tomography in people with Adult Ovarian Granulosa Cell Tumor, run by National Cancer Institute (NCI) at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Within 9 months of initiating study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06169124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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