Immunotherapy for Skin Cancer in Kidney Transplant Recipients
This study is testing a combination of nivolumab and ipilimumab (immunotherapy drugs that help your body's immune system fight cancer) with sirolimus and prednisone (medications to prevent kidney transplant rejection) for kidney transplant recipients. It's for people with skin cancer that can't be removed by surgery or has spread to other parts of the body. The goal is to see if this combination can control the cancer without causing the body to reject the transplanted kidney. Researchers will measure how many patients have their disease controlled at 14 weeks. You must be at least 18 years old and have a functioning kidney transplant to participate. The study plans to enroll 16 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 16 participants.
- What's involved
- You would undergo tumor biopsies, blood sample collections, CT scans, and potentially a kidney biopsy. You would also receive nivolumab and ipilimumab intravenously (through a vein).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome for disease control and allograft loss is measured at 14 weeks.
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NCT05896839
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~16 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyIpilimumabKidney BiopsyMagnetic Resonance Imaging
At a glance
Recruiting sites
25 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease control without allograft loss
Measured over At 14 weeks
Conditions
Where it's being run
26 sites across 11 statesFlorida7
Missouri5
California4
Illinois2
New York2
District of Columbia1
Georgia1
Kentucky1
Study leadership
- Evan J Lipson · PRINCIPAL_INVESTIGATOR · JHU Sidney Kimmel Comprehensive Cancer Center LAO
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be kidney transplant recipients with a functioning allograft who do not currently require dialysis
Patient's age must be \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of nivolumab and ipilimumab in kidney transplant recipients \<18 years of age, children are excluded from this study, but may be eligible for future pediatric trials
Patients must have histologically or cytologically confirmed non-uveal melanoma, basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma for which standard non-immunological medical, surgical, or radiation therapy would be insufficient (i.e., patients who are not surgical candidates). Patients with cutaneous squamous cell carcinoma or Merkel cell carcinoma may enroll without prior medical therapy (e.g., cetuximab or chemotherapy respectively). Non-immunologic standard therapies that patients must have received, refused or for which patients were ineligible include:
For patients with BRAF-mutant melanoma, prior therapies include BRAF/MEK inhibitors
For patients with Basal cell carcinoma, prior therapies include hedgehog pathway inhibitors
Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, i.e., at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm by chest x-ray or as \>= 10 mm with CT scan, magnetic resonance imaging (MRI), or calipers by clinical exam is preferred, but not required
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) performance status criteria
Leukocytes \>= 2,000/mcL
Absolute neutrophil count \>= 1,500/mcL
Platelets \>= 50,000/mcL
Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional ULN
Serum creatinine =\< 3 x ULN
dd-cfDNA =\< 1.0% and =\< 61% increase
The effects of nivolumab and ipilimumab on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential (WOCBP) receiving nivolumab must continue contraception for a period of 5 months after the last dose of nivolumab. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
Human immunodeficiency virus (HIV)-infected patients will be eligible for this trial if they are on effective antiretroviral regimens utilizing non-CYP-interactive agents and have an undetectable viral load. If there is evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated. If there is history of hepatitis C virus (HCV) infection, the patient must have been treated and have undetectable HCV viral load.
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion
Patients who have received a liver, lung, heart, or pancreas transplant; or allogeneic stem cell transplant; or any kind of bone marrow transplant
Patients unwilling or unable to undergo dialysis in the event of allograft failure
Patients with prior evidence of human leukocyte antigen (HLA) or non-HLA donor-specific antibodies (DSA)
Patients with a history of antibody- or cell-mediated allograft rejection within 3 months of study entry
Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment
Patients may have received prior anti-PD-(L)1 therapy; however, patients must not have any other checkpoint antibody targeting T-cell co-stimulation within 1 year of study enrollment. Prior history of adjuvant therapy is allowed if received over 1 year prior to enrollment. Prior receipt of oncolytic therapy (e.g., TVEC, RP1) is allowed
Patients must not be receiving any other investigational agents
Patients with leptomeningeal metastases, more than 3 untreated central nervous system (CNS) metastases, untreated brain metastases measuring \>1cm, or requiring treatment-dose steroids (\> 10 mg/day prednisone equivalents) for CNS-related symptoms. Exclusions are due to concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs. Patients with brain metastases meeting the above requirements are permitted to enroll
Patients must not have a history of severe hypersensitivity reaction to any monoclonal antibody
Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study
Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other significant condition(s) that would make this protocol unreasonably hazardous
Pregnant women are excluded from this study because nivolumab and ipilimumab have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with nivolumab or ipilimumab. These potential risks may also apply to other agents used in this study
Patients with autoimmune disease that is active or might recur and affect vital organ function will be eligible only after consultation with the study PI. Guillain-Barre (GB) syndrome, bullous skin disease, Stevens Johnson syndrome, or toxic epidermal necrolysis will be excluded
Patients must not have had evidence of active or acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study. In addition, patients with a history of cardiac disease including coronary artery disease (CAD), myocardial infarction (MI), cardiomyopathy, arrhythmia, heart block, should have an evaluation by history pulmonary embolism (PE) and appropriate testing to allow evaluation of any events that may occur on study. These may include troponin, electrocardiogram (EKG), echocardiogram (ECHO) as clinically indicated and may include results already in the medical record if available
What this trial measures
- Disease control without allograft lossAt 14 weeks
Defined as complete or partial response (CR; PR) or stable disease (SD), at 14 weeks per response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The percent of kidney transplant recipients who experience CR/PR/SD at 14 weeks and do not experience allograft loss after administration of nivolumab, ipilimumab, sirolimus, and prednisone will be calculated, along with the corresponding exact 95% confidence interval (CI).