Cemiplimab for Skin Cancer in Kidney Transplant Recipients
(CONTRAC-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
George Ansstas, MD
Principal Investigator
Washington University School of Medicine
Naoka Murakami, MD, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults who have had a kidney transplant (with good kidney function) and now have advanced skin cancer (cutaneous squamous cell carcinoma) that can't be removed by surgery. Participants must be able to switch to certain immune-suppressing drugs, not be pregnant or breastfeeding, and meet specific health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lead-in Treatment
Participants receive standardized immunosuppression (sirolimus and prednisone) for 7 to 14 days prior to starting cemiplimab treatment
Cemiplimab Treatment
Participants receive cemiplimab IV on Day 1 of every 21-day cycle for a maximum of 24 months
Cetuximab Salvage Therapy (optional)
Participants who progress during cemiplimab treatment may receive cetuximab as salvage therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
Trial Overview
The study tests cemiplimab (an immunotherapy drug) given along with standard immune suppression using sirolimus and prednisone in people with advanced skin cancer after a kidney transplant. The goal is to see if this treatment can fight the cancer without causing organ rejection.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
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