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New hope for rare ovarian cancer: Triple-Drug trial targets recurrent tumors

NCT ID NCT06169124

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This phase II trial is testing a combination of three drugs—darolutamide, leuprolide acetate, and exemestane—in 37 people with recurrent ovarian granulosa cell tumors. The drugs work by blocking hormones that may fuel tumor growth. The goal is to see if the combination can shrink or stabilize the tumors and prevent them from coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
darolutamide, leuprolide acetate, exemestane
What this could lead to
If successful, this combination could offer a new treatment option to shrink or stabilize recurrent ovarian granulosa cell tumors, potentially delaying disease progression.
What could go wrong
This is a small phase II trial with only 37 participants, so results may not apply to all patients. The combination may cause side effects and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * Prior treatment with AR inhibitors * Known hypersensitivity to the study drugs or their ingredients

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Conditions

The condition(s) this trial relates to.

maligant granulosa cell tumor of ovary ovarian granulosa cell tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult ovarian granulosa cell tumor

Contacts and locations

Locations

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260, United States

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025, United States

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009, United States

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405, United States

  • Billings Clinic Cancer Center

    Billings, Montana, 59101, United States

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715, United States

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017, United States

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007, United States

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503, United States

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401, United States

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938, United States

  • Carle at The Riverfront

    Danville, Illinois, 61832, United States

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711, United States

  • Community Medical Center

    Missoula, Montana, 59804, United States

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503, United States

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085, United States

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677, United States

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503, United States

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503, United States

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Hurley Medical Center

    Flint, Michigan, 48503, United States

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854, United States

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864, United States

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814, United States

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210, United States

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062, United States

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686, United States

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713, United States

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141, United States

  • Miami Valley Hospital South

    Centerville, Ohio, 45459, United States

  • Munson Medical Center

    Traverse City, Michigan, 49684, United States

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030, United States

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045, United States

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560, United States

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706, United States

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605, United States

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687, United States

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914, United States

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911, United States

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118, United States

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197, United States

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444, United States

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106, United States

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

  • University of Michigan Health - West

    Wyoming, Michigan, 49519, United States

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304, United States