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Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

NCT07715734 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-07-20

No results posted yet for this study

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

Interventions

DRUG

Cemiplimab

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

DRUG

Prednisone

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

DRUG

Sirolimus

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.

DRUG

Cetuximab (EGFR inhibitor)

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

Sponsors & Collaborators

Principal Investigators

  • George Ansstas, MD · Washington University School of Medicine

  • Naoka Murakami, MD, PhD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2031-03-31
Completion
2031-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715734 on ClinicalTrials.gov