Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

  • STATUS
    Recruiting
  • End date
    Oct 11, 2023
  • participants needed
    28
  • sponsor
    Mayo Clinic
Updated on 10 April 2022
platelet count
metastases
cancer
systemic therapy
serum pregnancy test
measurable disease
direct bilirubin
erythropoietin
neutrophil count
pembrolizumab
solid tumors
sezary syndrome
mycosis
pet scans
metastatic tumor

Summary

This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IV mycosis fungoides. Antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread.

Description

PRIMARY OBJECTIVES:

I. To evaluate the antitumor activity of pembrolizumab in patients with advanced mycosis fungoides (MF) as initial systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate safety of pembrolizumab in this patient population. II. To evaluate response rates of pembrolizumab in this patient population. III. To determine the progression free survival, duration of response, time to response and overall survival of pembrolizumab in this patient population.

CORRELATIVE OBJECTIVES:

I. To characterize the histologic features of the anti-tumor response in patients with advanced MF before and after treatment with pembrolizumab.

OUTLINE

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients receiving complete response during courses 2-9 are held for the remaining courses. If patients relapse while treatment is being held, the patient will then complete remaining courses.

After completion of study treatment, patients are followed up at 30 and 90 days, and then every 3 months for up to 1 year.

Details
Condition 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
Treatment Pembrolizumab
Clinical Study IdentifierNCT03695471
SponsorMayo Clinic
Last Modified on10 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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) (obtained =< 28 days prior to registration)
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)
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
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
Provide written informed consent
contraception for the course of the study through 120 days after the last dose
of the study medication
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
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)
Is currently participating and receiving study therapy or have participated in a study
Hypersensitivity to pembrolizumab or any of its excipients
of an investigational agent and received study therapy or used an
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
investigational device =< 4 weeks prior to registration
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 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has a known additional malignancy that is progressing or requires active treatment
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Exceptions: basal cell carcinoma of the skin or squamous cell carcinoma of the
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
skin that has undergone potentially curative therapy or in situ cervical
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
cancer
Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
Has received a live vaccine =< 30 days prior to registration
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
Sezary syndrome patients with high blood burden requiring immediate cytoreduction
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