Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Summary

This phase I trial studies how well tacrolimus, nivolumab, and ipilimumab work in treating kidney transplant recipients with cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Tacrolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tacrolimus, nivolumab, and ipilimumab may work better in treating kidney transplant recipients with cancer compared to chemotherapy, surgery, radiation therapy, or targeted therapies.

Timeline

Start

2019-11-08

Primary completion

2022-10-11

Completion

2026-09-19

Publications

• Schenk KM, Deutsch JS, Chandra S, Davar D, Eroglu Z, Khushalani NI, Luke JJ, Ott PA, Sosman JA, Aggarwal V, Schollenberger MD, Sharfman WH, Bibee KP, Scott JF, Loss MJ, Wang H, Qi H, Sharon E, Streicher H, Chen HX, Woodward RN, Bagnasco SM, Taube JM, Topalian SL, Brennan DC, Lipson EJ. Nivolumab + Tacrolimus + Prednisone +/- Ipilimumab for Kidney Transplant Recipients With Advanced Cutaneous Cancers. J Clin Oncol. 2024 Mar 20;42(9):1011-1020. doi: 10.1200/JCO.23.01497. Epub 2024 Jan 22.
• Bonilla M, Gudsoorkar P, Wanchoo R, Herrmann SM, Jhaveri KD. Onconephrology 2022: An Update. Kidney360. 2023 Feb 1;4(2):258-271. doi: 10.34067/KID.0001582022. Epub 2022 Dec 9.
• Trager MH, Coley SM, Dube G, Khan S, Ingham M, Samie FH, Geskin LJ, McDonnell D, Brouder D, Saenger Y, Carvajal R. Combination checkpoint blockade for metastatic cutaneous malignancies in kidney transplant recipients. J Immunother Cancer. 2020 Jun;8(1):e000908. doi: 10.1136/jitc-2020-000908.

Drugs

Indications