Indiana University is leading enrollment in a national Phase 3 clinical trial exploring new treatment options for patients with a difficult-to-treat form of bladder cancer: non-muscle invasive bladder cancer.
Non-muscle invasive bladder cancer is cancer that has not grown into the muscle layer of the bladder. For patients with high-risk disease, Bacillus Calmette-Guérin, commonly known as BCG, is an established treatment delivered directly into the bladder. The Phase 3 ABLE-22 clinical trial is studying treatment options for patients with high-grade, BCG-unresponsive non-muscle invasive bladder cancer.
IU is currently the highest-enrolling institution in the trial and accounts for more than 20% of patients enrolled in the study to date. Hristos Kaimakliotis, MD, is the site principal investigator for the study at Indiana University. IU’s strong participation reflects the bladder cancer program’s focus on clinical trials and multidisciplinary patient care.
“We are focused on providing cutting-edge care for our patients and seeking new treatment opportunities,” Kaimakliotis said. “We are committed to doing this while providing exceptional care and prioritizing patient wishes, safety and long-term goals.”
The ABLE-22 trial is enrolling patients whose high-grade cancer no longer responds to BCG treatment. For these patients, clinical trials can offer treatment options outside of standard-of-care cystectomy, or bladder removal, or other second-line therapies.
“The opportunity to maintain their own bladder and remain disease-free” is an important goal for patients participating in the trial, Kaimakliotis said.
The national Phase 3 ABLE-22 trial plans to enroll approximately 250 participants and is sponsored by Ferring Pharmaceuticals.
ABLE-22 is currently enrolling eligible patients at IU.
Note: The author used ChatGPT to help explain complex research in plain language. This article has been reviewed by Hristos Kaimakliotis, MD.
