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Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pembrolizumab in Treating Patients With Relapsed or Refractory Stage IB-IVB Mycosis Fungoides or Sezary Syndrome

A Phase 2 Study of MK-3475 for the Treatment of Relapsed/Refractory Mycosis Fungoides/Sezary Syndrome

NCT02243579•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial studies how well pembrolizumab works in treating patients with stage IB-IVB mycosis fungoides or Sezary syndrome that has returned after a period of improvement or has not responded to at least one type of treatment. Monoclonal antibodies, such as pembrolizumab, may block cancer growth in different ways by targeting certain cells.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the response rate of MK-3475 (pembrolizumab) in subjects with relapsed/refractory mycosis fungoides/Sezary syndrome (MF/SS). SECONDARY OBJECTIVES: I. To explore the clinical activity of MK-3475 in subjects with relapsed/refractory MF and SS with respect to the following endpoints: duration of response (DOR); progression-free survival (PFS); overall survival (OS). OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 3 weeks for up to 2 years (6 months for patients achieving complete response \[CR\]) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•This trial will include subjects with stage IB-IVB MF/SS (maximal stage since diagnosis will determine eligibility), and who have relapsed, are refractory, or progressed after at least one standard systemic therapy; current disease stage at time of entry will also be documented but will not be used for eligibility
•Subjects must have the following minimum wash-out and adverse event (AE) recovery period from previous treatments without treatment between documentation of relapse/progression and enrollment of specifically:
•* \>= 2 weeks for local radiation therapy
•* \>= 4 weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least 8 weeks
•* \>= 15 weeks for anti-cluster of differentiation (CD)137 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
•* \>= 2 weeks from resolution (i.e., =\< grade 1 or at baseline) from AEs due to procedures performed or therapeutic agents administered
•* \>= 2 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox, and therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteroids are allowed, topical corticosteroids are allowed)
•* \>= 2 weeks for phototherapy
•* \>= 1 week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
+18 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or targeted small molecule therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•* Note: patients with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
•* Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
•Patients who are currently participating in or have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
•Has a diagnosis of immunodeficiency or is receiving therapeutic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
•Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from AEs due to agents administered more than 4 weeks earlier
•Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
•Patients with known brain metastases should be excluded from this clinical trial
•* Patients with carcinomatous meningitis should also be excluded
•* Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment 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 trial treatment
+19 more criteria

Locations (8)

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Yale University

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

October 15, 2014

Primary Completion Date

January 4, 2018

Completion Date

April 1, 2019

Last Updated

September 20, 2019

Enrollment

ACTUAL participants

Conditions

Recurrent Mycosis Fungoides and Sezary SyndromeRefractory Mycosis Fungoides and Sezary SyndromeStage IB Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7

Interventions

Laboratory Biomarker Analysis

OTHER

Pembrolizumab

BIOLOGICAL

Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment

NCT04541017

Mycosis FungoidesRecurrent Mycosis Fungoides+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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