MedTrace Logo

Cemiplimab in AlloSCT/SOT Recipients With CSCC

NCT04339062 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-04-23

Study results available
· View outcomes & findings →

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

Conditions

Interventions

DRUG

Cemiplimab

Cemiplimab: via IV, flat predetermined dosage every 21 days.

DRUG

Everolimus

Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab

DRUG

Sirolimus

Sirolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab

DRUG

Prednisone

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

Sponsors & Collaborators

Principal Investigators

  • Glenn J Hanna, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2023-06-12
Completion
2025-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04339062 on ClinicalTrials.gov