NCT05538988

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

An Interventional, Single-arm, Open-label Phase I/II Study Investigating the Efficacy and Safety of Anti-PD1 Immunotherapy for the Treatment of Patients With Cutaneous T-cell Lymphoma (Mycosis Fungoides)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-02-01
• Completion: 2026-03-01
• First posted: 2022-09-14
• Last updated: 2025-06-27

Locations

1 site across 1 country: Canada