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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
Must not have
Sezary syndrome patients with high blood burden requiring immediate cytoreduction.
Men or women of childbearing potential who are unwilling to employ adequate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from registration to cr, cr90 or pr, assessed up to 1 year
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Sezary syndrome and need urgent treatment to reduce cancer cells in my blood.
Select...
I am of childbearing age and do not plan to use birth control.
Select...
I am currently breastfeeding.
Select...
I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
Select...
I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Select...
I have or had lung inflammation treated with steroids.
Select...
I am currently being treated for an infection.
Select...
I have been diagnosed with HIV.
Select...
I have an active tuberculosis infection.
Select...
I have not needed strong medication for an autoimmune disease in the last 2 years.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall cutaneous response (cutaneous complete response [CR], cutaneous 90 response [CR90] or cutaneous partial response [PR])
Secondary study objectives
Changes in mSWAT scores
Duration of response
Incidence of adverse events
+3 moreOther study objectives
Biomarker analysis - CD4 baseline to cycle 2
Biomarker analysis - CD4 pre and post pembrolizumab
Biomarker analysis - CD8 baseline to cycle 2
+6 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~3150
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,136 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,992 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.
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