Cemiplimab in AlloSCT/SOT Recipients With CSCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04339062
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Cemiplimab: via IV, flat predetermined dosage every 21 days.
  • Everolimus — DRUG
    Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab
  • Sirolimus — DRUG
    Sirolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab
  • Prednisone — DRUG
    40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapered dosing while receiving Cemiplimab

Study Details

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

Key Dates

Start date
Nov 3, 2020
Status verified
Apr 2025
Primary completion
Jun 12, 2023
Completion
Mar 1, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Cemiplimab
    Participants who received allogeneic hematopoietic stem cell transplant \-- Cemiplimab: via IV, flat predetermined dosage every 21 days
  • Experimental: Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone
    Participants who received a kidney transplant will receive * Cemiplimab via IV, flat predetermined dosage every 21 days * Everolimus or Sirolimus-least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab * Prednisone 40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapering doses while receiving Cemiplimab

Primary Outcome Measure

Rate of Renal Transplant Rejection (Cohort 2) or GVHD (Cohort 1). [ Time Frame: First dose of study treatment up to 100 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Dana Farber Cancer Institute· Boston, MA

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