Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07715734
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Cemiplimab is administered intravenously (IV) at a dose of 350mg over 30 minutes on Day 1 of each 21-day cycle.
  • 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
  • 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.
  • Cetuximab (EGFR inhibitor) — DRUG
    Cetuximab may be administered according to standard of care (SOC).

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard immunosuppression + Cemiplimab + Cetuximab (optional)
    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).

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From start of cemiplimab treatment through completion of follow-up (total estimated time 36 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
George Ansstas, MD
[email protected]
314-362-5672
Naoka Murakami, MD, PhD
[email protected]
314-362-4137
George Ansstas, MD (PRINCIPAL_INVESTIGATOR)
Naoka Murakami, MD, PhD (PRINCIPAL_INVESTIGATOR)
Ningying Wu, PhD (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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