Ongoing Clinical Trials for Peritoneal Neoplasm
There are currently 2 ongoing clinical trials investigating new treatment options for peritoneal neoplasm, also known as peritoneal cancer. These studies are being conducted across multiple European countries and are testing combinations of medications including relacorilant, nab-paclitaxel, and bevacizumab for patients with advanced, platinum-resistant disease.
Clinical trial locations
- Belgium
- France
- Germany
- Hungary
- Italy
- Poland
- Spain
Study of Relacorilant, Nab-Paclitaxel, and Bevacizumab for Patients with Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
This trial is testing a three-drug combination treatment for patients with advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The study focuses on patients whose cancer has become resistant to platinum-based treatments, meaning their disease has progressed within six months of completing such therapy.
Who can participate:
To be eligible for this study, you must have a confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. Your disease must be platinum-resistant, meaning it progressed within 183 days after completing your last platinum-based treatment. You should have received at least one but no more than three previous cancer treatments, with at least one being platinum-based. If you have a known BRCA1/2 mutation, you should have been treated with a PARP inhibitor unless it was unsuitable, unavailable, or you declined it.
You must have at least one measurable tumor and a life expectancy of at least three months. Your general health should be good enough to carry out light work, measured by what doctors call an ECOG performance status of 0 or 1. You need to be able to swallow pills without problems and should not have uncontrolled vomiting.
Important lab requirements include having adequate blood cell counts without recent transfusions or growth factor support, liver function tests within acceptable ranges, and kidney function with a creatinine clearance of at least 35 mL/min. You should also have minimal protein in your urine.
If you are capable of becoming pregnant, you must have a negative pregnancy test and agree to use highly effective non-hormonal birth control methods during the study, as hormonal contraceptives are not allowed.
Who cannot participate:
This study is only for female patients with the specific types of cancer mentioned above. Male patients and those with other cancer types cannot participate. There may also be restrictions for vulnerable populations who might have difficulty giving informed consent.
What the trial involves:
The study is testing whether adding relacorilant to standard treatment with nab-paclitaxel and bevacizumab can improve outcomes for patients with platinum-resistant disease. Relacorilant is a medication that blocks the effects of cortisol, a stress hormone that may help cancer cells grow. By blocking cortisol, researchers hope to slow down or stop cancer growth.
Nab-paclitaxel is a chemotherapy drug that stops cancer cells from dividing and growing. It is combined with a protein called albumin that helps it enter cancer cells more effectively. Bevacizumab works differently by blocking the growth of new blood vessels that tumors need to survive and grow.
During the trial, you will receive relacorilant as an oral capsule that you take by mouth. Both nab-paclitaxel and bevacizumab will be given through intravenous infusion directly into your vein. The medical team will explain the exact schedule and dosages.
Throughout the study, your health will be closely monitored with regular check-ups and assessments. The primary goal is to measure progression-free survival, which means the time from starting treatment until the disease gets worse or any other health problems occur. The study will also evaluate how well the tumor responds to treatment, how long the response lasts, and what side effects may occur. This trial is expected to continue until 2027.
Study of Relacorilant and Nab-Paclitaxel for Patients with Advanced, Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer
This trial is comparing two treatment approaches for patients with advanced, platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer. One group will receive a combination of relacorilant and nab-paclitaxel, while the other will receive nab-paclitaxel alone.
Who can participate:
To join this study, you must have a confirmed diagnosis of high-grade ovarian, primary peritoneal, or fallopian tube cancer that has become resistant to platinum treatment. This means your cancer worsened less than six months after finishing platinum-based therapy. You must be female and at least 18 years old.
You should have received at least one but no more than three previous cancer treatments. Importantly, you must have tried at least one treatment containing both a platinum drug and bevacizumab.
Your overall health should be good, with an ECOG performance status of 0 or 1, meaning you can carry out normal daily activities or light work. You must have at least one measurable tumor and a life expectancy of at least three months. You need to be able to swallow pills and should not have uncontrolled vomiting.
Your organs must be functioning well based on specific lab tests. If you have a tumor tissue sample available from a previous biopsy, you should agree to provide it, or you may need to undergo a new biopsy.
If you can become pregnant, you must have a negative pregnancy test and agree to use effective non-hormonal birth control methods throughout the study, as hormonal contraceptives are not permitted.
Who cannot participate:
Only female patients with the specific types of cancer being studied can participate. Patients under 18 or over 65 years old cannot join the trial. Male patients and those with different cancer types are excluded. Vulnerable populations who may need special protection or have difficulty giving informed consent may also be excluded.
What the trial involves:
This study aims to determine whether adding relacorilant to nab-paclitaxel treatment provides better results than nab-paclitaxel alone. When you join the study, you will be randomly assigned to one of the two treatment groups.
Relacorilant is an investigational medication that blocks cortisol, a stress hormone. By blocking cortisol’s effects, relacorilant may help reduce cancer cell growth and improve the effectiveness of chemotherapy.
Nab-paclitaxel is a chemotherapy drug that works by stopping cancer cells from dividing. This helps prevent the cancer from growing and spreading. It is already used to treat various cancers, including breast and pancreatic cancer.
If you are assigned to the combination group, you will take relacorilant as an oral capsule. All participants will receive nab-paclitaxel through intravenous infusion. The study team will provide specific information about dosages and schedules.
Throughout the trial, you will undergo regular assessments including imaging tests to check how the cancer is responding to treatment, along with blood tests and other evaluations. Treatment will continue until your disease progresses, you experience unacceptable side effects, or you choose to withdraw from the study. The study is expected to conclude by December 31, 2025, though individual participation may end earlier depending on your response to treatment. After completing treatment, you will enter a follow-up period to monitor long-term effects and outcomes.
Summary
Both ongoing clinical trials for peritoneal neoplasm are investigating the use of relacorilant, an investigational drug that blocks cortisol, in combination with established chemotherapy treatments. These studies specifically target patients with platinum-resistant disease, meaning their cancer has stopped responding to standard platinum-based treatments.
The trials are being conducted across six European countries: Belgium, France, Germany, Hungary, Italy, Poland, and Spain. Both studies share similar eligibility criteria, requiring patients to have advanced disease that has progressed within six months of platinum-based therapy.
A notable difference between the two trials is that one study tests a three-drug combination including bevacizumab, while the other compares a two-drug combination against nab-paclitaxel alone. Both trials aim to determine whether adding relacorilant can improve outcomes for patients with this challenging form of cancer.
These studies represent important research efforts to develop new treatment options for patients whose cancer has become resistant to standard therapies. Participants will be closely monitored throughout the trials to assess both the effectiveness and safety of these treatment combinations.
