Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT05896839
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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.
Interventions
-
Biopsy Procedure
(Procedure)
Undergo tumor biopsy
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
-
Computed Tomography
(Procedure)
Undergo CT scan
-
Ipilimumab
(Biological)
Given IV
-
Kidney Biopsy
(Procedure)
Undergo kidney biopsy
-
Magnetic Resonance Imaging
(Procedure)
Undergo MRI
-
Nivolumab
(Biological)
Given IV
-
Prednisone
(Drug)
Given PO
-
Sirolimus
(Drug)
Given PO
Eligibility criteria
Conditions
Locations
- UC San Diego Moores Cancer Center — La Jolla, California, United States
- Keck Medicine of USC Koreatown — Los Angeles, California, United States
- Los Angeles General Medical Center — Los Angeles, California, United States
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States
- University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Memorial Hospital East — Shiloh, Illinois, United States
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Siteman Cancer Center-South County — St Louis, Missouri, United States
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
- NYU Langone Hospital - Long Island — Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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