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Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome

NCT03617224 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-04-22

No results posted yet for this study

Summary

Hypothesis: Addition of low dose TSEBT to debulk MF/SS either before or during checkpoint blockade with anti-PD-1 pembrolizumab monoclonal antibody therapy will be safe and well tolerated.

Primary Objective:

• To determine the maximum tolerated dose (MTD) for the combination of total skin electron beam therapy (TSEBT) and pembrolizumab regimen.

Secondary Objectives:

* To determine the preliminary efficacy of the combination of TSEBT with pembrolizumab.
* To determine the impact on patient-reported health-related quality of life outcomes.

Conditions

  • Cutaneous T-Cell Lymphomas

Interventions

RADIATION

TSEBT

The regimen includes a rule-based "3+3" design for escalating regimen intensity of combined TSEBT and pembrolizumab.

DRUG

TSEBT and pembrolizumab

Dose regimens are sequential therapy of TSEBT with Pembrolizumab.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2022-07-24
Completion
2024-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03617224 on ClinicalTrials.gov