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Title:
Randomized phase 2 trial of gemcitabine + carboplatin + nivolumab versus gemcitabine + oxaliplatin + nivolumab in cisplatin-ineligible patients with metastatic urothelial cancer (HCRN GU16-287)
Protocol Number:
J1897
Phase:
Phase II
Physician:
Jean Hoffman-Censits
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To estimate the objective response rate to treatment with gemcitabine + carboplatin + nivolumab and gemcitabine + oxaliplatin + nivolumab in those patients who are unable to receive cisplatin and have metastatic urothelial cancer.
Eligibility:
No previous chemo (within 12 months of enrollment). Must have adequate organ function of bone marrow, kidney and liver functions. Cannot have had a prior malignancy within 3 years except locally curable cancers. Patients cannot have any autoimmune disorders. No prior treatment with an anti-PD1, anti PD-L1, anti PD-L2, or anti CTLA-4 antibody. Positive testing for Hepatitis B known history of HIV, any significant cardiovascular disease. cannot have had an organ or tissue transplant including stem cell transplant.
Treatment:
Patients will be randomized to either Arm A gemcitabine plus carboplatin plus nivolumab versus Arm B: gemcitabine plus oxaliplatin plus nivolumab. Patients will receive treatment every 21 days for a total of 6 cycles and if stable without disease progression or toxicities can continue "maintenance" single agent nivolumab for up to 24 cycles.
Population:
Adult
Last Update
03/05/2019 05:03 AM