New hope for kidney transplant patients with advanced skin cancer
NCT ID NCT05896839
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This study tests a combination of two immunotherapy drugs (nivolumab and ipilimumab) along with two anti-rejection medications (sirolimus and prednisone) in kidney transplant recipients who have advanced skin cancer that cannot be surgically removed or has spread. The goal is to see if this approach can control the cancer while keeping the transplanted kidney healthy. About 16 adults with functioning kidney transplants and certain types of skin cancer will participate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \[B-HCG\]) during the screening period. Follow-up evaluations will include interval sexual/menstrual histories as needed. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be considered postmenopausal. * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
25 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
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Locations
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Emory University Hospital/Winship Cancer Institute
ACTIVE_NOT_RECRUITINGAtlanta, Georgia, 30322, United States
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Huntsman Cancer Institute/University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
Contact Email: •••••@•••••
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Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITINGBaltimore, Maryland, 21287, United States
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Keck Medicine of USC Koreatown
RECRUITINGLos Angeles, California, 90020, United States
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITINGNew York, New York, 10016, United States
Contact Email: •••••@•••••
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Los Angeles General Medical Center
RECRUITINGLos Angeles, California, 90033, United States
Contact Email: •••••@•••••
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Memorial Hospital East
RECRUITINGShiloh, Illinois, 62269, United States
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NYU Langone Hospital - Long Island
RECRUITINGMineola, New York, 11501, United States
Contact Email: •••••@•••••
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
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Sibley Memorial Hospital
RECRUITINGWashington D.C., District of Columbia, 20016, United States
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Siteman Cancer Center at Christian Hospital
RECRUITINGSt Louis, Missouri, 63136, United States
Contact Email: •••••@•••••
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Siteman Cancer Center at Saint Peters Hospital
RECRUITINGCity of Saint Peters, Missouri, 63376, United States
Contact Email: •••••@•••••
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Siteman Cancer Center at West County Hospital
RECRUITINGCreve Coeur, Missouri, 63141, United States
Contact Email: •••••@•••••
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Siteman Cancer Center-South County
RECRUITINGSt Louis, Missouri, 63129, United States
Contact Email: •••••@•••••
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UC San Diego Moores Cancer Center
RECRUITINGLa Jolla, California, 92093, United States
Contact Email: •••••@•••••
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UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITINGAventura, Florida, 33180, United States
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UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITINGCoral Gables, Florida, 33146, United States
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITINGDeerfield Beach, Florida, 33442, United States
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UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITINGMiami, Florida, 33176, United States
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UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITINGPlantation, Florida, 33324, United States
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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USC / Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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University of Kentucky/Markey Cancer Center
RECRUITINGLexington, Kentucky, 40536, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
RECRUITINGNorth Miami, Florida, 33181, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
Contact Email: •••••@•••••
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