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

Sponsor
AHS Cancer Control Alberta
Study ID
NCT05538988
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Mycosis Fungoides

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    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

Study Details

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).

Key Dates

Start date
Dec 31, 2024
Status verified
Jun 2025
Primary completion
Feb 28, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab
    Study treatment includes administration of cemiplimab 350 mg intravenous every 21 days (+/﹣ 3 days)

Primary Outcome Measure

Objective Response Rate [ Time Frame: The analysis of the primary endpoint will occur 90 days after 16 patients complete week 27 assessments. ]

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