Cemiplimab for Cutaneous T-Cell Lymphoma

(BIOSELECT Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AHS Cancer Control Alberta

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Adults with advanced cutaneous T-cell lymphoma (mycosis fungoides) who have not responded to at least one prior therapy can join this trial. They must be able to consent, follow the study plan, and use effective birth control if of childbearing potential. People with certain organ dysfunctions or those taking immunosuppressants cannot participate.

Inclusion Criteria

I have tried at least one treatment before that didn't work.

My skin cancer (mycosis fungoides) is confirmed by a specialized board.

I am 18 years old or older.

Exclusion Criteria

I have recently used drugs that weaken my immune system.

I need radiation therapy along with other treatments.

I have a serious heart condition.

Treatment Details

Interventions

• Cemiplimab (Checkpoint Inhibitor)

Trial Overview The trial is testing cemiplimab's effectiveness in treating mycosis fungoides after other treatments have failed. It aims to see how well patients respond by measuring the reduction in their skin tumors.

Participant Groups

Group I: Cemiplimab Experimental Treatment 1 Intervention

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

Cemiplimab is already approved in Canada, Brazil for the following indications:

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+