In an oral abstract session at the 2016 Genitourinary Cancers Symposium, Matthew Galsky, MD, reported on the HCRN GU10-148 study, a phase II trial of gemcitabine and cisplatin plus ipilimumab as first-line treatment for patients with metastatic urothelial carcinoma. Dr. Galsky (pictured), of the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, is sponsor-investigator of the multi-center trial.

Gemcitabine plus cisplatin (GC) is standard treatment for advanced urothelial cancer. Ipilimumab has shown activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The study authors hypothesized that the combination of gemcitabine and cisplatin plus ipilimumab could build on the chemosensitivity of urothelial carcinoma to produce more durable responses and improved outcomes.

Thirty-six patients with metastatic urothelial carcinoma (median age 60) were enrolled in the study. Patients received a median of five cycles of GC (range: 1-6) and three doses of ipilimumab (range: 1-8). Objective response was seen in 64% of patients (50% partial and 14% complete), while stable disease was observed in 31% and progressive disease in 6% of patients.

The study authors concluded, “a phased schedule of gemcitabine and cisplatin plus immune checkpoint blockade was feasible in patients with metastatic urothelial carcinoma. Ipilimumab induced immunomodulatory effects despite concurrent chemotherapy. Survival data are not mature. Ongoing analyses are exploring the impact of gemcitabine and cisplatin alone, and gemcitabine and cisplatin plus ipilimumab, on antigen-specific T cell immunity, and correlating such findings with ‘outlier’ survival times.”

See the abstract.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 150 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 4,600 subjects have participated in Hoosier Cancer Research Network clinical trials.