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Title:
Randomized Phase II Study of Neoadjuvant Nivolumab with and without Urelumab in Patients with Cisplatin-Ineligible Muscle-Invasive Urothelial Carcinoma of the Bladder
Protocol Number:
J1682
Phase:
Phase II/III
Physician:
Noah Hahn
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To compare the post- treatment tumor infiltrating CD8+ T-cell density at cystectomy in cisplatin- ineligible MIBC patients treated with neoadjuvant Nivolumab plus Urelumab (Arm A) vs. Nivolumab alone (Arm B).
Eligibility:
Patients with histologically confirmed muscle- invasive urothelial carcinoma of the bladder defined as T2- T4 stage. Mixed histologies are acceptable provide urothelial carcinoma is the predominant histology ( greater than / equal to 50%)
Treatment:
The study population will include male and female patients over the age of 18 with muscle invasive urothelial carcinoma of the bladder (MIBC)who are not suitable for cisplatin- based chemotherapy, but are fit to undergo surgical resection of their cancer by cystectomy.A phase II clinical trial design randomizing patients with cisplatin- ineligible MIBC (stages T2- T4, N0-1, M0) to one of two treatment arms: Arm A- Nivolumab in combination with Urelumab of Arm B- Nivolumab monotherapy.
Population:
Adult
Last Update
03/05/2019 05:03 AM