Phase 2 Study of Nivolumab and Ipilimumab with Sirolimus and Prednisone for Kidney Transplant Recipients Having Advanced Skin Cancers That Cannot Be Removed or Have Spread

What this Trial Is About

Researchers are evaluating the combination of immunotherapy drugs nivolumab and ipilimumab with the immunosuppressants sirolimus and prednisone to treat advanced skin cancers that cannot be removed by surgery or have spread in patients who have received kidney transplants. This phase II trial aims to assess whether this combination can control cancer while preserving kidney transplant health. The study also explores immune system changes, tumor environment effects, and markers related to transplant rejection. Participants take sirolimus and prednisone orally daily starting one week before immunotherapy begins. Nivolumab and ipilimumab are given intravenously in the first two cycles at specific days, followed by tumor assessments at six weeks. Those showing stable disease or better continue nivolumab every four weeks for up to 24 cycles unless disease worsens or side effects occur. If progression happens, participants may receive a short course of nivolumab plus ipilimumab every three weeks, followed by nivolumab alone if response is achieved. Imaging, biopsies, and blood tests are performed throughout the study to monitor cancer and transplant status. Participants undergo MRI scans during screening and may have biopsies of tumors or kidneys if needed. CT scans and blood samples are collected regularly to track disease and immune responses. After treatment ends, follow-up visits occur every 12 weeks for one year, then every 16 weeks in the second year, and every 20 weeks up to five years. Researchers measure cancer response without kidney transplant loss at 14 weeks as the main outcome, as well as longer-term survival, transplant rejection rates, and immune changes over time.

Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer