Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

NCT07715734 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 26-x257
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.

Conditions

Kidney Transplant Recipient; Cutaneous Squamous Cell Carcinoma (CSCC); Advanced Cutaneous Squamous Cell Carcinoma; Kidney Transplant

Keywords

Cutaneous squamous cell carcinoma; Advanced cancer; Kidney transplant

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  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.

  From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)

Secondary Outcomes (9)

• Incidence of adverse events as assessed by CTCAE v6.0

  Start of lead-in treatment through 90 days after discontinuation of cemiplimab (total estimated time 27 months and 2 weeks)

• Discontinuation of treatment due to treatment-related adverse events (AEs)

  Start of lead-in treatment through completion of treatment (total estimated time 24 months and 2 weeks)

• Kidney allograft rejection rate

  From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)

• Allograft loss rate

  Start of cemiplimab treatment through completion of follow-up (total estimated time 36 months)

• Overall Survival (OS)

  Start of cemiplimab treatment to death, whichever comes first (estimated time frame 36 months)

Study Arms (1)

Standard immunosuppression + Cemiplimab + Cetuximab (optional)

EXPERIMENTAL

Patients will receive standardized immunosuppression (sirolimus and prednisone) lead-in treatment for 7 to 14 days prior to starting treatment with cemiplimab. Cemiplimab is given IV on Day 1 of every 21-day cycle for a maximum of 24 months. Sirolimus is continued during cemiplimab, and dynamic prednisone is continued for the first 6 cycles. If patient progresses during treatment with cemiplimab, patients will be offered cetuximab as salvage therapy at the investigator's discretion and will be administered according to standard of care (SOC).

Drug: Cemiplimab; Drug: Prednisone; Drug: Sirolimus; Drug: Cetuximab (EGFR inhibitor)

Interventions

Cemiplimab DRUG

Cemiplimab is administered intravenously (IV) at a dose of 350mg over 30 minutes on Day 1 of each 21-day cycle.

Also known as: Libtayo

Standard immunosuppression + Cemiplimab + Cetuximab (optional)

Prednisone DRUG

Prednisone is administered orally and taken about the same time each day. Prednisone will be pulsed for Cycles 1-6 and continued to be pulsed or dose reduced for Cycles 7+. For Cycles 1-6: 40 mg dose will be administered the day before each cycle (Day -1 or Day 21) and Days 1-3, 20mg dose Days 4-6, and 10mg dose Days 7-20. For Cycles 7+: Dose will be administered pulsed as Cycles 1-6 or 10mg daily

Also known as: Rayos, Sterapred, Deltasone

Standard immunosuppression + Cemiplimab + Cetuximab (optional)

Sirolimus DRUG

Sirolimus will be taken orally once daily at dose prescribed to achieve a goal trough level of 4-6 ng/mL. It should be taken around the same time daily. Sirolimus will be administered daily throughout each cycle.

Also known as: Rapamune

Standard immunosuppression + Cemiplimab + Cetuximab (optional)

Cetuximab (EGFR inhibitor) DRUG

Cetuximab may be administered according to standard of care (SOC).

Also known as: Erbitux

Standard immunosuppression + Cemiplimab + Cetuximab (optional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Note: prior topical or intralesional immunotherapies (e.g., imiquimod, talimogene laherparepvec) are permitted.
• 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.
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

cemiplimab; Prednisone; Sirolimus; Cetuximab

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Lactones; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George Ansstas, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Naoka Murakami, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Ansstas, MD

CONTACT

314-362-5672; gansstas@wustl.edu

Naoka Murakami, MD, PhD

CONTACT

314-362-4137; naoka@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)