Phase 2
N=9
Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides
Mycosis Fungoides · Sezary Syndrome · Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 · Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 · Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8
Bottom Line
View on ClinicalTrials.gov: NCT03695471 ↗Enrolled (actual)
9
Serious AEs
12.5%
Results posted
Aug 2025
Primary outcome: Primary: Proportion of Overall Cutaneous Responders at Their 9th or Final Cycle (Cutaneous Complete Response [CR], Cutaneous 90 Response [CR90] or Cutaneous Partial Response [PR]) — 0.25 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pembrolizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Overall Cutaneous Responders at Their 9th or Final Cycle (Cutaneous Complete Response [CR], Cutaneous 90 Response [CR90] or Cutaneous Partial Response [PR]) |
0.25 | — |
| SECONDARY Incidence of Adverse Events |
5; 4 | — |
| SECONDARY Percentage Change in mSWAT Score |
-5.015 | — |
| SECONDARY Progression Free Survival |
8.9 | — |
| SECONDARY Duration of Response |
7.6 | — |
| SECONDARY Time to Response |
2.04 | — |
| SECONDARY Median Overall Survival Time |
10.6 | — |
Summary
This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IV mycosis fungoides. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Eligibility Criteria
Inclusion Criteria
- Age >= 18 years
- Histological confirmation of one of the following:
- Stage IIB-IV mycosis fungoides not previously treated with systemic therapy
- Stage IB/IIA mycosis fungoides with Modified Severity Weighted Assessment Tool (mSWAT) >= 20 with high risk morphologic features defined as thick plaque disease and/or follicular involvement who have failed one form of skin-directed therapy.
- Sezary syndrome patients not previously treated with systemic therapy.
- Measurable disease based on mSWAT and/or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Note: Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to registration. Exception: Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Absolute neutrophil count (ANC) >= 1, 500 /mcL (obtained = = 100,000/mcL (obtained = = 9.0 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
- Serum total bilirubin = 1.5 ULN (obtained = 2.5 mg/dL (obtained = = 60 ml/min for subject with creatinine levels > 1.5 x institutional ULN (obtained =< 28 days prior to registration)
- Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT/INR or PTT is within therapeutic range of intended use of coagulants (obtained =< 28 days prior to registration)
- Negative urine or serum pregnancy test done =< 28 days prior to registration and =< 72 hours prior to receiving the first dose of study medication, for women of childbearing potential only.
- Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of the study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Male subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of the study medication.
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Willing to provide tissue samples for correlative research purposes.
Exclusion Criteria
- Any of the following because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Is currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device =< 4 weeks prior to registration.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =< 7 days prior to registration.
- Has a known history of active TB (Bacillus tuberculosis).
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) =< 4 weeks prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy =< 2 weeks prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent.
- Note: Subjects with =< grade 2 neuropathy are an e
Data sourced from ClinicalTrials.gov (NCT03695471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.