Pembrolizumab for Mycosis Fungoides

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Florida, Jacksonville, FLMycosis Fungoides+12 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well pembrolizumab works in treating patients with stage IB-IV mycosis fungoides.

Eligible Conditions
  • Mycosis Fungoides
  • Sezary Syndrome
  • Mycosis Fungoides and Sezary Syndrome

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Time from registration to CR, CR90 or PR, assessed up to 1 year

Day 21
Changes in mSWAT scores
Year 1
Time to response
Year 2
Overall survival
Year 5
Progression free survival
Up to 1 year
Biomarker analysis
Duration of response
Overall cutaneous response (cutaneous complete response [CR], cutaneous 90 response [CR90] or cutaneous partial response [PR])
Day 90
Incidence of adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Parkinsonism
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Inappropriate antidiuretic hormone secretion with 100%, Parkinsonism with 100%, Urinary tract infection with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab)
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (pembrolizumab)
Biological
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from registration to cr, cr90 or pr, assessed up to 1 year

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,949 Previous Clinical Trials
3,447,630 Total Patients Enrolled
8 Trials studying Mycosis Fungoides
434 Patients Enrolled for Mycosis Fungoides
National Cancer Institute (NCI)NIH
13,151 Previous Clinical Trials
41,162,770 Total Patients Enrolled
105 Trials studying Mycosis Fungoides
4,553 Patients Enrolled for Mycosis Fungoides
Jason C SluzevichPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
12 Total Patients Enrolled
Jason SluzevichPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 18 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You agree to give tissue samples for research purposes.

Frequently Asked Questions

What are some of the conditions that Pembrolizumab has been helpful in treating?

"Pembrolizumab is a medication used to treat various conditions, including malignant neoplasms, unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy." - Anonymous Online Contributor

Unverified Answer

Could you please list other instances in which Pembrolizumab has been studied?

"There are currently 1000 ongoing clinical trials involving pembrolizumab, with 122 of them being in Phase 3. Pembrolizumab studies are largely based out of Houston, Texas; however, there are 36030 medical sites running trials for this medication." - Anonymous Online Contributor

Unverified Answer

How many people are receiving care through this clinical trial?

"That is accurate. The clinicaltrials.gov website currently hosts information indicating that this study is still looking for participants. December 20th, 2018 was the first time this trial was posted and it has seen one update on March 22nd, 2022. This research project is only recruiting 28 individuals from a single location." - Anonymous Online Contributor

Unverified Answer

Has Pembrolizumab been cleared by the FDA?

"Pembrolizumab's safety is rated as a 2 since there is only limited data supporting its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Are researchers still looking for participants in this clinical trial?

"That is correct. Based on the information available from clinicaltrials.gov, this study appears to be open and recruiting patients. The listing for this trial was first posted on December 20th, 2018 with the most recent update occurring March 22nd, 2022. So far, 28 people have been enrolled at a single centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.