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GU10-148

Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Cancer Research Network GU10-148

Status: Closed to Accrual

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

  • Condition: Urothelial Carcinoma
  • Intervention:
    • Drug: Gemcitabine
    • Drug: Cisplatin
    • Drug: Ipilimumab
  • Phase: Phase 2

For full description, see www.clinicaltrials.gov.

Abstracts/Posters/Presentations:

  • BA Gartrell, NM Hahn, TE Hutson, G Sonpavde, RJ Hauke, A Starodub, AC Small, C-K Tsao, MD Galsky. Phase II trial of gemcitabine and cisplatin plus ipilimumab as first-line treatment for metastatic urothelial carcinoma: Hoosier Oncology Group GU10-148. Accepted as a Poster Presentation at the Trials in Progress Session at the ASCO Annual Meeting, June 1-5, 2012, Chicago, IL. J Clin Oncol 30, 2012 (suppl; abstr TPS4676)
  • Matt D. Galsky, Andrew V. Uzilov, Russell Bailey McBride, Huan Wang, Vaibhav G. Patel, John Sfakianos, Li Wang, Nicholas Akers, Gopa Iyer, David B. Solit, Takuro Saito, Mireia Castillo-Martin, Noah M. Hahn, Sumanta K. Pal, Mark T. Fleming, Ralph J. Hauke, Bojan Losic, Sacha Gnjatic, Rong Chen, Nina Bhardwaj; Icahn School of Medicine at Mount Sinai, New York, NY; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY; Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY; Genetics and Genomic Sciences, The Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY; Memorial Sloan Kettering Cancer Center, New York, NY; Johns Hopkins University, Baltimore, MD; City of Hope, Duarte, CA; US Oncology Research, Virginia Oncology Associates, Hampton, VA; Nebraska Cancer Specialists, Omaha, NE; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY. DNA damage response (DDR) gene mutations (mut), mut load, and sensitivity to chemotherapy plus immune checkpoint blockade in urothelial cancer (UC). Accepted to Poster Session B at the ASCO 2017 Genitourinary Cancers Symposium, February 16-18, 2017, Orlando, Fla. J Clin Oncol 35, 2017 (suppl 6S; abstract 300). See abstract.

Project Manager: Dana Musapatika, dmusapatika@hoosiercancer.org; (317) 634-5842, ext. 39.