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BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma

NCT05538988 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-06-27

No results posted yet for this study

Summary

Background - Advanced cutaneous T-cell lymphoma (mycosis fungoides, MF) is an incurable extranodal mature lymphoma with poor prognosis. Currently available therapies provide only short-term remissions.

Rationale - MF is an immunogenic cancer and expresses a high number of neoantigens. therefore it it reasonable to assume that it would respond to immune checkpoint inhibitors.

Objectives - The primary objective is to test the clinical efficacy (objective response rate) of the immune checkpoint inhibitor cemiplimab in patients with advanced mycosis fungoides (MF) who failed first-line therapy, defined as the sum of complete and partial responses (where at least 50% reduction of mSWAT is achieved).

Conditions

  • Mycosis Fungoides

Interventions

DRUG

Cemiplimab

Cemiplimab is a recombinant human IgG monoclonal antibody known as a programmed cell death 1 (PD-1) immune checkpoint inhibitor. The PD-1 pathway is an immune system checkpoint that may be exploited by tumour cells to escape active T-cell surveillance. Cemiplimab binds to PD-1 on T cells and blocks the interaction with its ligands, PD-L1 and PD-L2. Inhibition of the receptor/ligand signaling restores the anti-tumour immune response

Sponsors & Collaborators

  • AHS Cancer Control Alberta

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-02-28
Completion
2026-03-31

Countries

  • Canada

Study Locations

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Entities

Drugs

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 NCT05538988 on ClinicalTrials.gov