Cemiplimab for Advanced Skin Cancer in Kidney Transplant Patients
This study is looking at how well cemiplimab works for kidney transplant recipients who have advanced cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. We want to see if cemiplimab can fight the cancer without causing problems with your transplanted kidney. You would receive cemiplimab through an IV, along with other medications like prednisone and sirolimus, which help manage your immune system. Doctors will also monitor for a biomarker called MET. The main goal is to see how many participants have their cancer shrink or disappear. This study is for adults aged 18 and older with advanced CSCC that cannot be removed by surgery. The study is currently recruiting about 22 participants.
- Study design
- This is a Phase 2, single-arm study, meaning all participants receive the same treatment, and it is open-label, so you and your doctors will know what treatments you are receiving. It plans to enroll about 22 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for an estimated total of 36 months after starting cemiplimab treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07715734
Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~22 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:CemiplimabPrednisoneSirolimusCetuximab (EGFR inhibitor)
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- George Ansstas, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
- Naoka Murakami, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
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
Histologically confirmed locoregionally advanced and unresectable or recurrent/metastatic cutaneous squamous cell carcinoma (CSCC). Definitions that encompass unresectable disease include any of the following, after discussion at the multidisciplinary meeting:
Anatomically unresectable disease to include carotid artery encasement; invasion into the skull base, cavernous sinus, sagittal sinus; pre-vertebral fascia/vertebral body/vertebral artery; disseminated distant metastatic disease
Functionally unresectable disease resulting in the loss of sight, oral competency/speech/swallowing, or limb
Biologically unresectable disease to include satellitosis, in-transit/dermal metastasis, or disease which has failed 2 or more prior surgeries (by an experienced CSCC surgeon) or failed curative intent radiation therapy
Measurable disease per RECIST 1.1.
Received a kidney transplant. Must have a functioning allograft, be at least 6 months from last allograft transplantation, and have had no evidence of biopsy-proven allograft rejection (Banff 1A or above, requiring treatment) at any time. In order to be considered a functioning allograft, the following criteria must be met:
Estimated glomerular filtration rate (GFR) ≥ 30 mL/min (using the CKD-EPI equation either by Cr or Cystatin C based measurement) (Inker LA et al, 2021)
Baseline proteinuria \< 0.5 g/day (by spot urine protein-creatinine ratio or 24-hr urine collection, if available)
Not receiving antiproliferative immunosuppressive medications. If patients are on antiproliferative immunosuppressive medications, they must be discontinued for at least 7 days before initiation of C1D1 (i.e. at the screening visit and/or during the lead-in period)
At least 18 years of age.
ECOG performance status ≤ 2
Adequate bone marrow and organ function as defined below:
Leukocytes ≥ 2.2 K/cumm
Absolute neutrophil count ≥ 1.0 K/cumm
Platelets ≥ 90 K/cumm
Total bilirubin within normal institutional limits (except in cases where Gilbert syndrome is known or suspected, where total bilirubin should be \< 3 mg/dL)
AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
The effects of cemiplimab on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 4 months after last dose of cemiplimab.
Able to switch immunosuppression regimen to sirolimus and prednisone if not already receiving sirolimus and prednisone as SOC.
Able to understand and willing to sign an IRB approved written informed consent document and willing and able to comply with clinic visits and study-related procedures. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion
Received chemotherapy or radiotherapy within 2 weeks prior to C1D1. Note: prior cetuximab exposure is permitted, but it must have been discontinued at least 2 weeks prior to the start of cemiplimab.
Received prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CLTA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (including chimeric antigen receptor \[CAR\] T-cell therapies).
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
Currently receiving any other investigational agents.
Unable to swallow pills.
Currently receiving any medications or substances that are strong inhibitors or inducers of CYP3A4.
Receipt of a live vaccine within 28 days of C1D1.
Receipt of COVID-19 vaccination within 7 days of C1D1 or for which the planned COVID-19 vaccinations would not be completed 7 days prior to C1D1.
Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression and if they are at least 4 weeks out from treatment. They must also be asymptomatic and on stable doses of anti-epileptic drugs (AEDs) and oral corticosteroids at the time of enrollment
A history of allergic reactions attributed to or known hypersensitivity to cemiplimab or any of its components or other agents used in the study.
Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. Note: the following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded.
Any condition that requires ongoing/continuous corticosteroid therapy (\> 10 mg prednisone/day or anti-inflammatory equivalent) within 7 days prior to C1D1. Patients who require a brief course of steroids (up to 2 days in the week before C1D1) or physiologic replacement are not excluded.
Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring hospitalization or treatment with IV anti-infectives within 14 days prior to C1D1; NYHA heart failure classifications of Class II, III, or IV; myocardial infarction or acute coronary syndrome within 12 months prior to C1D1; unstable angina pectoris; cardiac arrhythmia; transient ischemic attack or stroke within 12 months prior to C1D1.
Known non-infectious pneumonitis or any history of interstitial lung disease.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
Uncontrolled infection with HIV, hepatitis B or C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent).
Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count \> 350 either spontaneously or on a stable antiviral regiment are eligible. For these participants, monitoring will be performed as per local standards.
Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of cemiplimab.
Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: if serum HBV DNA is above the limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.
Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are eligible.
What this trial measures
- Overall response rate (ORR)From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)
ORR is defined as the proportion of patients with Complete Response (CR) or Partial Response (PR). ORR will be assessed according to RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.