A medical oncologist at Stephenson Cancer Center at OU Medicine was one of only 25 faculty members in North America selected to attend a prestigious workshop in clinical trial development.
The result is that Abhishek Tripathi, M.D., returned to Oklahoma with a fully vetted clinical trial that will soon begin enrolling patients to test a new combination drug therapy for the treatment of metastatic bladder cancer.
The workshop was organized by the American Society of Clinical Oncology and the American Association for Cancer Research. To compete for a spot in the workshop, Tripathi developed his own clinical trial concept and secured funding to conduct it, a process that took a year. After a rigorous selection process, his was among the concepts chosen.
The value of the workshop is that Tripathi worked with senior physicians, scientists and biostatisticians with decades of experience designing clinical trials. Their feedback helped him fine-tune the trial so that it would have the best chance of approval from the Food and Drug Administration. The workshop also included the input of patient advocates, who provided an important vantage point about the trial, such as how often patients would be required to come to the clinic, frequency of blood draws and number of treatments.
“The crucial advantage of this workshop is that it provides a 360-degree intensive look at the clinical trial protocol,” Tripathi said. “I received feedback from a scientific and statistical standpoint, as well as from a patient safety and patient advocacy perspective. All of that feedback combined enhances the potential for the trial to successfully answer the questions we are asking.”
The clinical trial will test the effectiveness of an existing immunotherapy medication, avelumab, combined with an investigational new drug. The new drug has already shown promise, by itself, in shrinking tumors in patients with ovarian cancer, Tripathi said. In his trial, the hope is that the new drug will work in concert with the immunotherapy drug to further stimulate the immune system to shrink and control the tumor cells in bladder cancer. The trial will be held at multiple sites around the United States, and Tripathi will serve as the national principal investigator over the entire trial.
In the United States, about 75,000 new cases of bladder cancer are diagnosed every year, and approximately 10,000 of those patients have advanced disease or cannot undergo surgery, Tripathi said. In years past, chemotherapy was the only treatment option for patients who could not tolerate surgery, but with the advent of immunotherapy, their outlook improved. Not everyone responds to immunotherapy, however, which drives oncologists like Tripathi to develop new drug combinations for metastatic cancer.
“I take care of most of the patients whose cancer has spread beyond the bladder, and those patients tend to have a very poor survival rate with existing therapies,” he said. “That’s why clinical trials are incredibly important to push the needle forward and develop promising new treatment options.”