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A novel clinical trial involving the immunotherapy combination of Opdivo and Yervoy will open soon in Chicago. The goal is to study the drugs’ efficacy 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 effectiveness of the drug combination when used for unresectable pleural mesothelioma.
Bristol Myers Squibb manufactures Opdivo and Yervoy, known generically as nivolumab and ipilimumab. The U.S. Food and Drug Administration approved the combination for pleural mesothelioma in 2020, making it the first new systemic mesothelioma treatment 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 close to 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 pre-surgery treatment, post-surgery treatment and observation, will last at least 18 months.
Researchers Expand Use of Immunotherapy
An estimated 1,000 people are diagnosed annually in the U.S. with peritoneal mesothelioma, which develops in the thin layer of tissue lining the abdomen and often spreads throughout the abdominal cavity. Pleural mesothelioma grows in the tissue lining the lungs and chest cavity.
Although the pleural and peritoneal types of mesothelioma are molecularly and immunologically distinct, the Opdivo/Yervoy combination’s growing success with other cancers has led researchers to continue expanding its reach.
Opdivo and Yervoy both are 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 the T cells discover the tumor, while Yervoy proliferates and activates the T cells to kill the tumor cells.
Peritoneal mesothelioma is being treated most effectively today with a combination of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, also known as HIPEC. The hope is that adding the immunotherapy will make it even better.
Although the Opdivo/Yervoy combination is not FDA-approved for peritoneal mesothelioma, the University of Texas MD Anderson Cancer Center in Houston has reported some success recently with off-label usage of the treatment for patients with inoperable disease.
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Study to Focus on Effectiveness with Surgery
The goal of the Opdivo/Yervoy clinical trial is to determine whether administering the immunotherapy combination before surgery decreases the tumor burden, and if it delays any cancer regrowth if given after surgery. It will be the first time Opdivo and Yervoy have been used together with patients also receiving surgery and HIPEC.
Trial principal investigator and surgical oncologist Dr. Kiran Turaga did not respond to requests from The Mesothelioma Center for additional insight.
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 immunotherapy combination with those receiving standard chemotherapy.
|Three-year Survival Rate||23%||15%|
|Three-year Durable Response Rate||28%||0%|
|Median Duration of Response||11.6 months||6.7 months|
|Median Overall Survival||18.1 months||14.1 months|
“Results from the CheckMate 743 trial have changed the way physicians treat pleural mesothelioma,” said Dr. Abderrahim Oukessou, thoracic cancers development lead for Bristol Myers Squibb. “We continue to see more evidence for the sustained survival benefits of dual immunotherapy across several tumors.”
The company said the Opdivo/Yervoy combination has also shown significant survival improvement in phase III clinical trials involving metastatic melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma and advanced renal cell carcinoma.
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