New clinical trials to investigate combination immunotherapy for treating advanced cancers

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City of Hope physician-scientists recently opened two clinical trials to investigate a combination of cytokines and immunotherapy that may be able to transform nearly-impossible-to-treat cancer into a disease that can be corralled into remission.

Daneng Li, M.D., is treating patients with advanced liver (hepatocellular) cancer, while Joseph Chao, M.D., is treating patients with advanced stomach and esophageal cancer (gastric and gastroesophageal junction adenocarcinoma). Both City of Hope medical oncologists are offering hope to patients who have tried chemotherapy and other treatments for their cancer without experiencing prolonged remission.

The studies are supported by Brooklyn ImmunoTherapeutics and use the biopharmaceutical company's experimental cytokine treatment, IRX-2, combined with either nivolumab (liver cancer study) or pembrolizumab (stomach and esophageal cancer study), both U.S. Food and Drug Administration-approved immune checkpoint antibodies.

"This combination therapy attempts to turbo boost the immune system so that it can attack cancer," said Chao, assistant clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope. "We are releasing the brakes and adding gas."

Both Li and Chao are principal investigators of the phase 1b clinical trials that are testing safety and efficacy of the combination treatment. If the first group of participants don't experience significant side effects, the trials will transition to the expansion part. In total, each physician expects to enroll about 20 patients in their respective clinical trials.

"We're trying to turn potentially 'cold tumors' - those with strong fortresses nearly impenetrable to the immune system - into 'hot tumors' that have walls equipped with ladders for immune T cells so that more patients can derive benefit from treatment with immunotherapy," said Li, assistant clinical professor in the Department of Medical Oncology & Therapeutics Research at City of Hope.

Sunil Sharma, M.D., director of the Applied Cancer Research and Drug Discovery Division at Translational Genomics Research Institute (TGen), is co-principal investigator in the phase 1b clinical trials. TGen, an affiliate of City of Hope, will perform DNA, RNA and protein sequencing of tumor tissue to potentially identify biomarkers that can help target the treatments.

"After successful laboratory testing, we are excited to offer this new therapeutic approach for our patients," Sharma said. "We hope this unique immunologic approach will storm the walls surrounding these cancers and defeat these malignancies."

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