Cemiplimab for Cutaneous T-Cell Lymphoma (BIOSELECT Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the immunotherapy drug cemiplimab can help to treat patients with mycosis fungoides who have failed first line therapy. The primary objective is to see what the response rate is for these patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Cemiplimab may cause immune-related side effects such as inflammation in various organs, allergic reactions during infusion into the body, tiredness, stomach issues, changes in blood cells count which could increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles)

This trial's timeline: 3 weeks for screening, Varies for treatment, and the euroqol-5d questionnaire will be administered at screening, cycle 1 (each cycle is 21 days) and every 12 weeks (cycle 5, 9, etc. )thereafter until end of treatment (max of 17 cycles) for reporting.