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Immune Checkpoint Blockade for Kidney Transplant Recipients with Selected Unresectable or Metastatic Cancers
This study is to determine the safety and efficacy of nivolumab alone or with ipilimumab to treat cancer in patients who have received a kidney transplant.
Objective: 1. To estimate the percent of kidney transplant recipients with selected advanced cancers for whom standard therapies would be insufficient who, 16 weeks after administration of prednisone, tacrolimus, and nivolumab, experience complete response (CR), partial response (PR), or stable disease (SD) without allograft loss. 2. To estimate the objective response rate (ORR), rate of allograft loss, and durations of progression-free survival (PFS) and overall survival (OS) in the study population. 3. To estimate the ORR and rate of allograft loss in patients who experience progressive disease (PD) after administration of nivolumab and 1) receive ipilimumab and nivolumab, or 2) decrease or discontinue immunosuppression.
BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); Yervoy (Ipilimumab)