Randomized phase 2 trial of gemcitabine + carboplatin + nivolumab versus gemcitabine + oxaliplatin + nivolumab in cisplatin-ineligible patients with metastatic urothelial cancer (HCRN GU16-287)
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
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.
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.
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