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New drug shows promise for rare ovarian cancer in early trial

NCT ID NCT05348356

Disease control Sponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 3 times

Summary

This phase 2 trial tested the drug nirogacestat in 53 people with recurrent ovarian granulosa cell tumors, a rare type of ovarian cancer. The goal was to see if the drug could shrink tumors or slow the disease. Participants took nirogacestat orally, and researchers measured how many responded to treatment and how long they lived without the cancer getting worse.

What this could mean

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

Active substance
nirogacestat (a gamma secretase inhibitor oral tablet)
What this could lead to
If it works, this could offer a new treatment option for people with recurrent ovarian granulosa cell tumors, potentially shrinking tumors or delaying progression.
What could go wrong
This is a small phase 2 trial with only 53 participants, so results may not apply to everyone. The drug may not work as hoped, and side effects are possible.

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

53 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Key Inclusion Criteria: * Has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment * Have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1.1 criteria * Have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values Key Exclusion Criteria: * Has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat * Has had a major cardiac or thrombo-embolic event within 6 months of signing informed consent * Has abnormal QT interval at Screening, or has congenital or acquired long QT syndrome or a history of additional risk factors for Torsades de Pointes * Has current or chronic history of liver disease or known hepatic or biliary abnormalities * Has received bevacizumab treatment or other monoclonal antibody therapy with targeted anti-angiogenic activity for OvGCT within 28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment; * Has received treatment for OvGCT including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment: hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment

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Conditions

The condition(s) this trial relates to.

maligant granulosa cell tumor of ovary ovarian cancer ovarian granulosa cell tumor

As listed by the trial registrant

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

Ovarian cancer Ovarian granulosa cell tumor Ovarian granulosa-stromal tumor

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • David C. Pratt Cancer Center

    St Louis, Missouri, 63141, United States

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204, United States

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Jagiellonian Innovation Centre Clinical Research Centre

    Krakow, 30-348, Poland

  • Maria Sklodowska-Curie Bialystok Oncology Center

    Bialystok, 15-027, Poland

  • Maria Sklodowska-Curie National Institute of Oncology-National Research Institute, Clinic of Oncological Gynecology

    Warsaw, 02-781, Poland

  • Memorial Sloan Kettering Cancer Institute

    New York, New York, 10065, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • UCLA-JCCC Dept. of OBGYN - Women's Health Clinical Research Unit

    Los Angeles, California, 90095, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UW/Fred Hutch Cancer Center

    Seattle, Washington, 98109, United States

  • University Teaching Hospital Poznan, Department of Oncological Gynaecology

    Poznan, 60-569, Poland

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87102, United States

  • Women's Cancer Care

    Covington, Louisiana, 70433, United States

  • Women's Cancer Center at Kettering

    Kettering, Ohio, 45429, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.