A Study of Relacorilant Combined with Different Treatments for Gynecological Cancers

The purpose of this study is to learn how well relacorilant works and how safe it is when used with other treatments for gynecological cancers, such as ovarian and endometrial cancer.


Why this Research Matters

Sometimes cancer stops responding to chemotherapy. When this happens, the cancer may continue to grow or spread. One reason this may happen is because cancer cells can use a natural body hormone called cortisol to help protect themselves from treatment. Relacorilant is a study drug that blocks the effects of cortisol. By doing this, it may help chemotherapy work better against cancer. If you decide to join this study, you will first have tests to find out if you qualify. These tests may take place in one day or over many days. During these visits, you will have a physical exam. The study team will measure your blood pressure, heart rate, breathing rate, temperature, height, and weight. You will be asked questions about your health and the medicines you take. Blood and urine samples will be collected. You will also have a heart test called an ECG, which checks how your heart is working. You may also have imaging tests, such as a CT scan or MRI, so doctors can look inside your body. If you qualify, you will be placed into 1 of 3 groups based on your type of cancer. You will take relacorilant by mouth and receive nab-paclitaxel through an IV, a tube placed into a vein. Depending on your study group, you may also get bevacizumab through an IV. During the study, you will have many of the same tests and answer similar questions as before. You will also keep a diary to record when you take the study drug each day. Your participation in this study will last about 12 to18 months, depending on your type of cancer. You will have 3 treatment visits, 1 end of treatment visit, and 1 follow up visit about 30 days after your last dose of the study drug. The study team may also ask you to take part in long-term follow-up visits so they can continue to check your health. New treatment groups may be added to the study if new cancer treatments become available. You and your insurance will cover the costs of your regular medical care. However, you will not be charged for study-related tests, procedures, office visits, or study drugs. You may get up to $90 for each study visit you complete.


Who can Participate

Adult

You may be able to join the study if you are 18 years old or older and have ovarian cancer or endometrial cancer. You must have a life expectancy of at least 3 months, be able to swallow and keep down pills, and have received cancer treatment in the past. If you can become pregnant, you must have a negative pregnancy test before joining the study. You cannot join the study if you had surgery within the 4 weeks before starting. You also cannot have a health condition that needs corticosteroid treatment, were diagnosed with another type of cancer within the past 3 years or received a live vaccine within 30 days before starting the study. The study doctor or someone from the study team will review all study requirements with you to determine whether you qualify.


Study ID

Protocol Number: 26-0057

More information available at ClinicalTrials.gov: NCT06906341


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Marisa Moroney, MD

Principal Investigator