Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

NCT03695471 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: MC1788NCI-2018-0202317-010349
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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; Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IVA1 Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IVA2 Mycosis Fungoides and Sezary Syndrome AJCC v8; Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v8

Outcome Measures

Primary Outcomes (1)

• Proportion of Overall Cutaneous Responders at Their 9th or Final Cycle (Cutaneous Complete Response [CR], Cutaneous 90 Response [CR90] or Cutaneous Partial Response [PR])

  Will be assessed by the Modified Severity Weighted Assessment Tool (mSWAT). All calculated values will use the last-observation-carried forward for any participants who withdraw, are lost to follow up, or exit the study per protocol. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients will be analyzed using Mann-Whitney U for nonparametric data and the student t-test. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. mSWAT is calculated using body surface area (BSA) of each MF lesion (palm plus fingers of the patient ≈ 1% BSA) in each of 12 areas of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch=1, plaque=2, and tumor =4) and generating a sum of the subtotals of each lesion subtype.

  7 months

Secondary Outcomes (6)

• Incidence of Adverse Events

  7 months

• Percentage Change in mSWAT Score

  Baseline to 7 months

• Progression Free Survival

  28 months

• Duration of Response

  26 months

• Time to Response

  7 months

Other Outcomes (9)

• Biomarker Analysis - CD4 Pre and Post Pembrolizumab

  Up to 1 year

• Biomarker Analysis - CD4 Baseline to Cycle 2

  Up to 1 year

• Biomarker Analysis - CD8 Baseline to Cycle 2

  Up to 1 year

Study Arms (1)

Treatment (pembrolizumab)

EXPERIMENTAL

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.

Biological: Pembrolizumab

Interventions

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (pembrolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 =\< 28 days prior to registration)
• Platelet count \>= 100,000/mcL (obtained =\< 28 days prior to registration)
• Hemoglobin \>= 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 X upper limit of normal (ULN) OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN (obtained =\< 28 days prior to registration)
• Aspartate transaminase (AST) and alanine transaminase (ALT) =\< 2.5 X ULN OR =\< 5 X ULN for subjects with liver metastases (obtained =\< 28 days prior to registration)
• Albumin \> 2.5 mg/dL (obtained =\< 28 days prior to registration)
• Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance \>= 60 ml/min for subject with creatinine levels \> 1.5 x institutional ULN (obtained =\< 28 days prior to registration)

You may not qualify if:

• 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 exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Exceptions: subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging =\< 4 weeks prior to registration and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least =\< 7 days prior to registration. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mycosis Fungoides; Sezary Syndrome

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Jason Sluzevich
• Organization: Mayo Clinic

Sluzevich.Jason@mayo.edu

904-953-6402

Study Officials

• Jason C. Sluzevich, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: February 4, 2020
• Primary Completion: June 21, 2023
• Study Completion: October 8, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 11, 2025

Record last verified: 2024-12

Locations

US (1)