Cemiplimab for Mycosis Fungoides

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cross Cancer Institute, Edmonton, Canada
Mycosis Fungoides+3 More
Cemiplimab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions

  • Mycosis Fungoides

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mycosis Fungoides

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 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)

Week 99
Assessment of Treatment Safety
Week 12
Health Related Quality of Life (Dermatological Life Quality Index)
Week 12
Health Related Quality of Life (EuroQol-5D)
Week 12
Health Related Quality of Life (Brief Older People's Quality of Life)
Week 99
Assessment of Progression Free Survival (PFS)
Week 27
Objective Response Rate
Week 99
Duration of Objective Response to Therapy
Week 48
Reduction in mSWAT during Therapy.

Trial Safety

Safety Progress

1 of 3

Other trials for Mycosis Fungoides

Trial Design

1 Treatment Group

Cemiplimab
1 of 1
Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Cemiplimab · No Placebo Group · Phase 1 & 2

Cemiplimab
Drug
Experimental Group · 1 Intervention: Cemiplimab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 1
~400

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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)
Closest Location: Cross Cancer Institute · Edmonton, Canada
Photo of Edmonton  1Photo of Edmonton  2Photo of Edmonton  3
2011First Recorded Clinical Trial
2 TrialsResearching Mycosis Fungoides
401 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must be 18 years of age or older.\n
You have stage IIB disease.\n
Patients of childbearing/reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.