In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous
squamous cell carcinoma in participants who have previously received an allogeneic
hematopoietic stem cell transplant or kidney transplant.
This research study involves the following drug(s):
Everolimus or Sirolimus
This an open-label, two cohort, phase I/II research study to evaluate the safety and
effectiveness of Cemiplimab as a treatment for advanced cutaneous squamous cell
carcinoma in participants who have received allogeneic hematopoietic stem cell or kidney
The research study procedures include screening for eligibility, study treatment,
participant evaluations and safety follow-up visits. It is expected that about 12 people
will take part in this research study.
Participants will be divided into two groups (cohorts) of allogeneic hematopoietic
stem cell recipients or kidney transplants recipients.
Allogeneic hematopoietic stem cell recipients will only receive the study treatment
drug of Cemiplimab.
Kidney transplant recipients will receive the study treatment drug of Cemiplimab
along with the immunosuppressant drugs of Everolimus or Sirolimus and Prednisone to
prevent kidney rejection.
The U.S. Food and Drug Administration (FDA) has approved Cemiplimab as a treatment option for
patients with advanced cutaneous squamous cell cancer, but the FDA has not approved the use
of Cemiplimab in participants who have received allogeneic hematopoietic stem cell
transplants or kidney transplants in the past.
-- Cemiplimab is a type of drug called a monoclonal antibody. Antibodies are proteins
naturally found in your blood that fight infections. A monoclonal antibody is a special kind
of antibody that is manufactured as a medication to target specific proteins in the body that
may be involved this type of cancer.
Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed
death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells
from destroying other cells. Blocking the receptor is expected to help immune cells attack
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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