To many people, the word "cancer" can be frightening. This was the case for Erma Wilson Muldrow who had been experiencing frequent urination, a condition that was not only getting worse but was soon accompanied by other symptoms such as stomach pain.
A urine specimen test by her primary care provider found that there was blood in her urine. She was referred to a local urologist for a scope and biopsy which confirmed Erma had bladder cancer.
Bladder cancer is the result of cells in the bladder changing and growing rapidly and uncontrollably. The mass that forms as a result of these cellular changes, called a tumor, can be harmless (benign), which means it is not likely to spread to other parts of the body. However, some tumors are deemed likely to spread (malignant) and cause significant health issues if left untreated.
While bladder removal surgery is the gold standard treatment for BCG unresponsive NMIBC, the trial’s aim is to find an alternative option to help patients keep their bladders while preventing cancers from coming back. It combines immune checkpoint inhibitors with an oncolytic virus, CG0070, that is genetically engineered to attack cancer cells. The solution containing the virus is infused into the bladder to ignite an immune response, and that response is in turn amplified by the immunotherapy treatment that releases the natural brakes on the immune system.
“The oncolytic virus is thought to work through a two-pronged attack,” said Dr. Roger Li, a genitourinary surgeon at Moffitt Cancer Center and the CORE1 trial’s principal investigator. “First by targeting and destroying the cancer cells, and secondly, to stimulate an anti-tumor immune response.”
Erma was referred to Moffitt where she was enrolled in a phase 1 study of CG0070 combined with Nivolumab in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC), MCC 20575. This is a six-week treatment followed by optional TURBT before proceeding to radical cystectomy. She also received an immune checkpoint inhibitor, Pembrolizumab, every six weeks until year two.
"This treatment is for patients who had previous experience with chemotherapy and were all very pleased with the lack of toxicity. There are no delays to surgical treatment seen, thus far," said Dr. Roger Li, a principal investigator of the study and urologist at Moffitt Cancer Center. "This trial is a good option for patients who are ineligible for chemotherapy due to various comorbidities such as renal insufficiency, hearing loss, peripheral neuropathy, heart failure, poor performance status or for those who refuse chemotherapy."
“We’re seeing very promising preliminary results from this study,” said Li. “In the first 18 patients enrolled, all but two had a complete response that was seen at their three-month cystoscopy.”
According to Li, of the six patients to have reached the one-year mark, all had a complete response confirmed by a random bladder biopsy under cystoscopic guidance.
“There’s been a lot of work behind the scenes on developing the guidelines surrounding clinical trials in this disease space,” said Li. “Since then, pembrolizumab remains the only drug that has received FDA approval, demonstrating a three-month complete response rate of around 40%. Our results compare very favorably to that.”
Erma is doing well and is ready to celebrate her one-year anniversary of remission. She credits her recovery to the wonderful team of providers at Moffitt.
"Dr. Sexton, Dr. Li and Dr. Jain were kind and caring," said Erma. "I can see that they care and respect their patients."
If you’d like to refer a patient to Moffitt Cancer Center, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.