Immunotherapy Clinical Trial Opens in Chicago
May 8, 2015
Internationally recognized mesothelioma specialist Dr. Hedy Kindler is recruiting patients for what could become a groundbreaking clinical trial at the University of Chicago Medicine’s Comprehensive Cancer Center.
Her expectations are high.
There are 90 different clinical trials in various stages around the country today testing pembrolizumab, the hottest new immunotherapy cancer drug, but only one trial involves malignant mesothelioma.
The University of Chicago has it.
“This is really exciting,” she told the Mesothelioma Applied Research Foundation last month. “This is an exciting class of drugs. Not only do they shrink the tumors, but they have a sustained and prolonged response. This is taking it to the next level.”
She believes her trial will build on the success of a smaller study completed recently by the University of Pennsylvania, where pembrolizumab shrank or stopped the growth of tumors in 19 of the 25 mesothelioma patients who received it.
“There was a very high response rate, and an even higher rate of disease control,” she said.
Pleural and Peritoneal Patients Are Eligible
Patients diagnosed with pleural and peritoneal mesothelioma are eligible for the Chicago trial, which is expected to include 65 participants and run through 2018.
Prospective participants already should have completed one or two rounds of chemotherapy and experienced disease progression. Exceptions will be made, though, for those who declined standard chemotherapy or were intolerant if they are clinically appropriate.
Because expectations for pembrolizumab have grown considerably in recent weeks, Kindler is expecting to attract patients from around the country.
“We’re in Chicago. It’s convenient for people to travel here. We have a great airport,” she said. “We designed [the study] this way because we know people will want to travel.”
Patients will receive pembrolizumab through a 30-minute intravenous procedure. They will be treated every 21 days for up to 24 months, in the absence of cancer progression or unacceptable toxicity.
They also will be eligible for an additional year of pembrolizumab if the mesothelioma progresses after completing the trial.
Side Effects Expected to Be Mild
Based on the earlier study, Kindler also believes the side effects will be minimal, which is typical with the immunotherapy class of drugs.
“[Pembrolizumab] appears to be pretty well tolerated. The side effects have been modest,” she said. “Anytime you rev up the immune system, you can get some funky side effects, but they have been well tolerated and reasonable.”
There currently are no FDA-approved second-line treatments for mesothelioma that have progressed beyond standard therapy. Pembrolizumab is being touted as the treatment that will potentially fill that void. Much will depend on results from this trial.
Pembrolizumab is designed to work by blocking PD-1 (programmed cell death), a protein that prevents a person’s own immune system from killing the tumor cells. By blocking this protein, pembrolizumab allows the immune system to recognize and destroy the tumor cells without harming healthy ones.
Pembrolizumab was approved by the FDA in 2014 for the treatment of melanoma, a form of skin cancer. It is being tested now, and with promising early results, for the potential treatment of numerous other diseases.
Another Clinical Trial Coming Soon
Kindler said the University of Chicago soon will be opening another mesothelioma clinical trial for patients who have yet to receive any therapy but are awaiting surgical resection. The tumors, which will be treated with pembrolizumab before surgery, will be analyzed closely after being removed.
“The thought is that the fewer lines of therapy you’ve had, the potential of it working is greater,” she said. “It’s a window of opportunity study. It also could help us tremendously to understand the biology of what this drug does to the tumor.”
The Mesothelioma Program in Chicago, which is one of the largest in the country, also includes renowned thoracic surgeon Dr. Wickii Vigneswaran.
“We really have a passion for this disease,” Kindler said.