A novel peritoneal mesothelioma clinical trial is currently enrolling patients. It aims to investigate the effect of immunotherapy on peritoneal mesothelioma. The trial will use the combination of Opdivo® and Yervoy®. This combination treatment is approved for pleural mesothelioma.
The trial stands out among mesothelioma clinical trials because it focuses on peritoneal mesothelioma. Most registered mesothelioma trials study the more common form: pleural mesothelioma. As such, this trial provides an uncommon opportunity for peritoneal mesothelioma patients.
Peritoneal Mesothelioma Clinical Trial Details
The University of Chicago Medicine Comprehensive Cancer Center (UCMCCC) is hosting the trial. It aims to enroll a total of 37 patients. To qualify, participants must have a confirmed diagnosis of peritoneal mesothelioma. They also need to meet additional requirements, including:
Peritoneal mesothelioma occurs in the lining of the abdomen, called the peritoneum. It is the second most common form of mesothelioma.
- Being at least 18 years of age
- Having adequate health status
- Qualifying for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
Once enrolled, participants will undergo immunotherapy treatment before CRS and HIPEC. The immunotherapy will consist of Opdivo (nivolumab) and Yervoy (ipilimumab). Patients may also receive additional Opdivo and Yervoy after CRS and HIPEC.
Doctors hope to determine whether Opdivo and Yervoy will decrease the amount of cancer before surgery. They also want to learn if the drugs will extend the time it takes for mesothelioma to come back after treatment.
The study officially started in December 2021. It is expected to run through February 2025.
Understanding Checkpoint Inhibitors
Immune checkpoints are a safeguard within the immune system. These checkpoints prevent immune cells from attacking healthy cells. Cancer cells can use these checkpoints to avoid being attacked by the immune system.
Checkpoint inhibitors are a form of immunotherapy. They block cancer cells from exploiting immune checkpoints. This can allow the body’s immune cells to attack and kill cancer cells. Opdivo and Yervoy are checkpoint inhibitors.
Trial Includes Immunotherapy Combination Found Effective in Pleural Mesothelioma
The combination of Opdivo and Yervoy has already achieved success in pleural mesothelioma. Another clinical trial, called CheckMate 743, highlighted the combination’s efficacy. Participants received the immunotherapy drugs or standard chemotherapy. Opdivo and Yervoy extended survival by about four months versus chemotherapy.
Pleural mesothelioma occurs in the lining around the lungs, called the pleura. It is the most common form of mesothelioma.
Results from CheckMate 743 earned U.S. Food and Drug Administration (FDA) approval for Opdivo and Yervoy. Regulators approved the combination for inoperable pleural mesothelioma.
Peritoneal Immunotherapy Trial Differs From CheckMate 743
The new immunotherapy trial will investigate the same drug combination as CheckMate 743. However, the UCMCCC trial and CheckMate 743 have important differences.
- Different patient populations: CheckMate 743 involved pleural mesothelioma patients who did not qualify for surgery. The UCMCCC trial will enroll peritoneal mesothelioma patients who do qualify for surgery.
- Different treatment approaches: CheckMate 743 treated patients with Opdivo and Yervoy or chemotherapy. The UCMCCC trial will treat all participants with Opdivo and Yervoy, then surgery and HIPEC, then Opdivo and Yervoy, again.
These differences make it hard to estimate how the results of the two trials may compare. Any patient interested in the UCMCCC trial should discuss it with their oncologist. The doctor can help the patient understand the risks and potential benefits of the trial.
Opdivo® and Yervoy® Clinical Trial Allows Peritoneal Mesothelioma Patients to Help Future Patients
The UCMCCC trial provides an opportunity for peritoneal mesothelioma patients to help others. Immunotherapy has not been extensively studied in this form of cancer. Doctors do not yet know how effective Opdivo and Yervoy are for peritoneal cases. Trial participation can help provide this information.
Clinical trial data can improve the understanding of how Opdivo and Yervoy function in peritoneal mesothelioma. This knowledge can help doctors choose the most effective treatment option for future patients.
Any patient considering a clinical trial should discuss it with their oncology team. The healthcare providers can help the patient weigh their options and choose the best treatment approach.