Study on Pembrolizumab and Mogamulizumab for Advanced, Relapsed, or Hard-to-Treat Cutaneous T-cell Lymphomas

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05956041

Provider View

This clinical trial is testing a combination of two drugs, pembrolizumab and mogamulizumab, to see if they can help treat advanced cutaneous T-cell lymphomas that have returned or are not responding to treatment. The study will last up to two years, with regular assessments to monitor progress.

Patient Parameters

Program Overview

This study is exploring the use of two drugs, pembrolizumab and mogamulizumab, in patients with advanced cutaneous T-cell lymphomas that have either come back or are not responding to other treatments. The treatment cycles last six weeks, with pembrolizumab given on the first day of each cycle and mogamulizumab given on specific days. Patients will continue treatment until their disease progresses, they experience unacceptable side effects, or they meet other criteria for stopping. If a patient achieves a complete response after two cycles, they may continue treatment for an additional six months. If the complete response is confirmed and sustained, they may stop treatment and enter an observation period. If the disease progresses during this period, they may receive additional treatment cycles.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization for the release of personal health information.
  • Must be 18 years or older.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a confirmed diagnosis of cutaneous T-cell lymphoma (Mycosis Fungoides/Sezary Syndrome) at Stage IIB-IVB.
  • Must have measurable disease according to specific criteria within 30 days before starting the study.
  • Must have failed at least one previous systemic therapy.
  • Must provide a tissue sample for analysis.
  • Must have adequate organ function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Must have a life expectancy of at least six months.
  • Must be able to understand and comply with study procedures.

Exclusion Criteria

  • History of HIV infection.
  • Active Hepatitis B or C infection.
  • Previous treatment with pembrolizumab or mogamulizumab.
  • Recent radiation therapy within seven days before starting the study.
  • Current or recent use of high-dose steroids or other immunosuppressive therapy.
  • History of autoimmune disease requiring treatment in the past two years, except for certain conditions like vitiligo or alopecia.
  • History of lung disease requiring steroids.
  • Other active cancers requiring treatment in the past two years.
  • Active infection requiring treatment.
  • Previous stem cell or organ transplant.
  • Pregnant or breastfeeding women.
  • Severe allergy to pembrolizumab or mogamulizumab.
  • Recent use of investigational drugs or vaccines.
  • Psychiatric or substance abuse disorders that interfere with study participation.
  • Any condition or treatment that might affect study results or participation.

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