Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Pembrolizumab for Mycosis Fungoides
Phase 2
Waitlist Available
Led By Jason C Sluzevich
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Stage IIB-IV mycosis fungoides not previously treated with systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from registration to cr, cr90 or pr, assessed up to 1 year
Awards & highlights
Study Summary
This trial will study how well pembrolizumab works in treating patients with stage IB-IV mycosis fungoides.
Who is the study for?
Adults over 18 with stage IB-IV mycosis fungoides or Sezary syndrome, who have failed at least one skin-directed therapy or haven't had systemic treatment. Participants must be able to provide a recent biopsy and meet certain health criteria like adequate organ function. Pregnant women, nursing mothers, those with certain other cancers or infections, and individuals on immunosuppressive treatments are excluded.Check my eligibility
What is being tested?
The trial is testing pembrolizumab's effectiveness for patients with advanced stages of mycosis fungoides. Pembrolizumab is an immunotherapy drug that may boost the immune system's ability to fight cancer by blocking tumor growth.See study design
What are the potential side effects?
Pembrolizumab can cause side effects such as fatigue, skin reactions, inflammation in organs like lungs (pneumonitis), hormonal gland problems (like thyroid disorders), infusion-related reactions, and it might worsen autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My mycosis fungoides is between stages IIB-IV and hasn't been treated with systemic therapy.
Select...
I have a specific skin cancer (mycosis fungoides) at an early stage but it's severe and previous treatments haven't worked.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My hemoglobin level is above 9.0 g/dL without needing transfusions or EPO recently.
Select...
I have Sezary syndrome and haven't had systemic therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from registration to cr, cr90 or pr, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from registration to cr, cr90 or pr, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall cutaneous response (cutaneous complete response [CR], cutaneous 90 response [CR90] or cutaneous partial response [PR])
Secondary outcome measures
Changes in mSWAT scores
Duration of response
Incidence of adverse events
+3 moreOther outcome measures
Biomarker analysis
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 cycles or until complete response in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,659 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,362 Total Patients Enrolled
Jason C SluzevichPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to pembrolizumab or any of its ingredients.I have another cancer besides skin or early cervical cancer that needs treatment.I have not received a live vaccine in the last 30 days.I have Sezary syndrome and need urgent treatment to reduce cancer cells in my blood.I am of childbearing age and do not plan to use birth control.I am currently breastfeeding.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I've recovered from my last cancer treatment, except for mild neuropathy.I have or had lung inflammation treated with steroids.I am 18 years old or older.My mycosis fungoides is between stages IIB-IV and hasn't been treated with systemic therapy.I have a specific skin cancer (mycosis fungoides) at an early stage but it's severe and previous treatments haven't worked.I agree to provide a recent biopsy sample or, if not possible, an older sample with approval.I have Sezary syndrome and haven't had systemic therapy.I have stable brain metastases, not on steroids for 7 days, and no carcinomatous meningitis.I am fully active or restricted in physically strenuous activity but can do light work.My hemoglobin level is above 9.0 g/dL without needing transfusions or EPO recently.My kidney function, measured by creatinine or its clearance, is within the required range.My blood clotting tests are normal or managed if I'm on blood thinners.I agree to use birth control during and up to 120 days after the study.I am willing to give tissue samples for research.I am currently being treated for an infection.I have been diagnosed with HIV.I have an active tuberculosis infection.I am a man who can father children and will use birth control during and for 4 months after the study.I have taken a pregnancy test recently and it was negative.I have not needed strong medication for an autoimmune disease in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger