New Opdivo / Yervoy Mesothelioma Clinical Trial Begins Soon
Research and clinical trials
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A new clinical trial involving the immunotherapy combination of Opdivo and Yervoy will soon open in Chicago. The aim is to study the effectiveness of drugs when added to surgery for patients with peritoneal mesothelioma cancer.
The single-center phase II clinical trial follows a recent report detailing the impressive three-year efficacy of the drug combination when used for unresectable pleural mesothelioma.
Bristol Myers Squibb manufactures Opdivo and Yervoy, generically called nivolumab and ipilimumab. The United States Food and Drug Administration approved the association for pleural mesothelioma in 2020, making it the first new systemic treatment for mesothelioma in 15 years. Health organizations around the world, including those in Japan, China and the European Union, have issued similar first-line treatment approval.
This latest clinical trial is expected to include nearly 40 patients and last at least three years. It was approved in September and is scheduled to begin Jan. 1 at the University of Chicago Medicine Comprehensive Cancer Center. Participation, including preoperative treatment, postoperative treatment and observation, will last for at least 18 months.
Researchers expand the use of immunotherapy
In the United States, approximately 1,000 people are diagnosed with peritoneal mesothelioma each year, which develops in the thin layer of tissue that lines the abdomen and often spreads throughout the abdominal cavity. Pleural mesothelioma develops in the tissues that line the lungs and chest cavity.
Although the pleural and peritoneal types of mesothelioma are molecularly and immunologically distinct, the growing success of the Opdivo / Yervoy combination with other cancers has led researchers to continue to expand its scope.
Opdivo and Yervoy are both known as checkpoint inhibitor drugs, but they work in different ways. When used with mesothelioma, they have shown an effective synergistic response with T cells, a type of white blood cell that is part of the immune system. Opdivo helps T cells discover the tumor, while Yervoy proliferates and activates T cells to kill tumor cells.
Peritoneal mesothelioma is most effectively treated today with a combination of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, also known as CHIP. The hope is that adding immunotherapy will make it even better.
Although the Opdivo / Yervoy combination is not FDA approved for peritoneal mesothelioma, the MD Anderson Cancer Center at the University of Texas at Houston recently reported some success with off-label use of the treatment for patients with the disease. of inoperable disease.
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Study to focus on the effectiveness of surgery
The objective of the Opdivo / Yervoy clinical trial is to determine whether giving the combination of immunotherapies before surgery decreases tumor burden and whether it delays cancer regrowth if given after surgery. This will be the first time that Opdivo and Yervoy will be used with patients who have also undergone surgery and HIPEC.
The trial’s principal investigator and surgical oncologist, Dr Kiran Turaga, did not respond to requests from the Mesothelioma Center for additional information.
Three-year data from the latest clinical trial, named CheckMate 743, was presented at the European Society for Medical Oncology conference last month. It involved patients with inoperable pleural mesothelioma and compared those receiving the combination immunotherapy with those receiving standard chemotherapy.
CheckMate 743 Clinical Trial Results
|Opdivo / Yervoy||Chemotherapy|
|Three-year survival rate||23%||15%|
|Sustainable response rate over three years||28%||0%|
|Median response time||11.6 months||6.7 months|
|Median overall survival||18.1 months||14.1 months|
“The results of the CheckMate 743 trial have changed the way doctors treat pleural mesothelioma,” said Dr Abderrahim Oukessou, Chest Cancer Development Manager for Bristol Myers Squibb. “We continue to see more evidence of the sustained survival benefits of dual immunotherapy on multiple tumors.”
The company said the Opdivo / Yervoy combination also showed significant improvement in survival in Phase III clinical trials in metastatic melanoma, non-small cell lung cancer, squamous cell carcinoma of the esophagus and advanced renal cell carcinoma.
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