RecruitingPhase 1Phase 2NCT05896839

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


Sponsor

National Cancer Institute (NCI)

Enrollment

16 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy drugs (nivolumab and ipilimumab) along with prednisone and sirolimus for kidney transplant recipients who have developed serious skin cancers that cannot be removed with surgery. **You may be eligible if...** - You have had a kidney transplant with a working kidney (not on dialysis) - You are 18 or older - You have confirmed melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma that cannot be treated with standard surgery or radiation - Your cancer is inoperable or has spread **You may NOT be eligible if...** - Your transplanted kidney is no longer functioning (you are on dialysis) - You are under 18 years old - You have uveal melanoma (a type of eye cancer) - You have serious organ dysfunction that would make immunotherapy unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALIpilimumab

Given IV

PROCEDUREKidney Biopsy

Undergo kidney biopsy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given IV

DRUGPrednisone

Given PO

DRUGSirolimus

Given PO


Locations(26)

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

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT05896839


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