Actively Recruiting
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
16
Participants Needed
26
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be kidney transplant recipients with a functioning allograft who do not currently require dialysis
- Patients must be 18 years of age or older
- Diagnosed with non-uveal melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma not suitable for surgery or standard non-immunological treatments
- Patients with cutaneous squamous cell carcinoma or Merkel cell carcinoma may enroll without prior medical therapy
- For BRAF-mutant melanoma, prior BRAF/MEK inhibitor therapy required
- For basal cell carcinoma, prior hedgehog pathway inhibitor therapy required
- Measurable disease by RECIST 1.1 criteria with at least one lesion measurable in size
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky �360%)
- Leukocytes �3e= 2,000/mcL
- Absolute neutrophil count �3e= 1,500/mcL
- Platelets �3e= 50,000/mcL
- Total bilirubin �3c= 1.5 times institutional upper limit of normal (ULN)
- AST/ALT �3c= 2.5 times institutional ULN
- Serum creatinine �3c= 3 times ULN
- Donor-derived cell-free DNA (dd-cfDNA) �3c= 1.0% and �3c= 61% increase
- Women of childbearing potential must use contraception and have a negative pregnancy test before enrollment
- Patients with HIV on effective antiviral therapy with undetectable viral load are eligible
- Patients with controlled hepatitis B or C infection are eligible
- Ability to understand and provide informed consent or have a legally authorized representative to do so
You will not qualify if you...
- Patients who have received a liver, lung, heart, pancreas, allogeneic stem cell, or bone marrow transplant
- Patients unable or unwilling to undergo dialysis if kidney transplant fails
- Presence of donor-specific antibodies (HLA or non-HLA)
- History of antibody- or cell-mediated kidney transplant rejection within 3 months prior to study
- Unresolved significant adverse events from prior therapies
- Receipt of checkpoint antibodies targeting T-cell co-stimulation within 1 year prior to enrollment (except anti-PD-(L)1 therapy)
- Concurrent use of other investigational agents
- Presence of leptomeningeal metastases, more than 3 untreated brain metastases, or untreated brain metastases larger than 1 cm
- Requirement for high-dose steroids (>10 mg/day prednisone equivalent) for CNS symptoms
- History of severe allergic reactions to monoclonal antibodies or similar compounds
- Uncontrolled active infections or serious illnesses including symptomatic heart failure, unstable angina, cardiac arrhythmia
- Pregnant or breastfeeding women
- Active or potentially recurrent autoimmune diseases affecting vital organs without consultation
- History of Guillain-Barre syndrome, bullous skin disease, Stevens Johnson syndrome, or toxic epidermal necrolysis
- Active or acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or advanced abdominal cancer
- History of significant cardiac disease requiring evaluation prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
3
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
9
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
11
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States, 33181
Actively Recruiting
12
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
13
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
14
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
15
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
16
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
17
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
18
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
19
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
20
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
21
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
22
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
23
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
24
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
25
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
26
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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