Cemiplimab in AlloSCT/SOT Recipients With CSCC (NCT04339062) | Clinical Trial Compass
CompletedPhase 1/2
Cemiplimab in AlloSCT/SOT Recipients With CSCC
United States12 participantsStarted 2020-11-03
Plain-language summary
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):
* Cemiplimab
* Everolimus or Sirolimus
* Prednisone
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed, advanced or metastatic cutaneous squamous cell carcinoma (cSCC) with 1 or more measurable lesions (greater than or equal to 1 cm).
* A history of either (Cohort 1) allogeneic hematopoietic stem cell transplant (alloHSCT) and ≥ 2 years or 730 days from day 0 of their HSCT with adequate bone marrow function (see Section 3.1.6) and off of all systemic immunosuppression (topical agents permitted) for at least 3 months prior to enrollment; sequelae of chronic graft versus host disease (GVHD) is permitted (i.e. chronic dry eyes, sclerodermatous skin changes, etc.) if the patient is not on systemic immunosuppression, or (Cohort 2) a renal transplant with a functioning allograft (at least 6 months from allograft transplant) as determined by estimated glomerular filtration (GFR) rate (CKD-EPI equation \[40\], Appendix A) ≥30 mL/min, baseline proteinuria lower than 0.5 g/day (spot urine protein-creatinine ratio), and off antiproliferative immunosuppressive medications.
* Age 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix B).
* Participants must have adequate organ and marrow function as defined below:
* leukocytes ≥ 2,200/mcL
* absolute neutrophil count ≥ 1,000/mcL
* platelets ≥ 90,000/mcL
* total bilirubin within normal institutional limits (except in cases where Gilbert syndrome is known or suspected, where total bilirubin should be \< 3 m…
What they're measuring
1
Rate of Renal Transplant Rejection (Cohort 2) or GVHD (Cohort 1).
Timeframe: First dose of study treatment up to 100 days