← Klinické štúdie • Transplantácia obličky
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
A Phase 2 Study of Nivolumab and Ipilimumab in Combination With Sirolimus and Prednisone in Kidney Transplant Recipients With Selected Unresectable or Metastatic Cutaneous Cancers
Stručný súhrn
This phase II trial tests the combination of nivolumab and ipilimumab with sirolimus and prednisone for the treatment of skin (cutaneous) cancer that cannot be removed by surgery (unresectable) or that has spread from where it first started to other places in the body (metastatic) in kidney transplant recipients. Immunotherapy with nivolumab and ipilimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Sirolimus and prednisone are immunosuppressants that are given to keep the body from rejecting the transplanted kidney. Giving nivolumab and ipilimumab in combination with sirolimus and prednisone may kill more cancer cells, while also keeping the transplanted kidney healthy, in patients with unresectable or metastatic cutaneous cancer who have received a kidney transplant.
Základné údaje
| Ochorenia | Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Basal Cell Carcinoma, Metastatic Carcinoma in the Skin, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Unresectable Basal Cell Carcinoma, Unresectable Melanoma, Unresectable Merkel Cell Carcinoma, Unresectable Skin Squamous Cell Carcinoma |
|---|---|
| Intervencie |
PROCEDURE: Biopsy Procedure PROCEDURE: Biospecimen Collection PROCEDURE: Computed Tomography BIOLOGICAL: Ipilimumab PROCEDURE: Kidney Biopsy PROCEDURE: Magnetic Resonance Imaging BIOLOGICAL: Nivolumab DRUG: Prednisone DRUG: Sirolimus |
| Sponzor | National Cancer Institute (NCI) |
| Plánovaný počet | 16 |
| Začiatok | 2024-07-24 |
| Predp. ukončenie (primárne) | 2027-01-31 |
| Krajiny | United States |
| Posledná aktualizácia | 2026-06-15 |