Pembrolizumab in Treating Patients With Stage IB-IV Mycosis Fungoides

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT03695471
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Feb 4, 2020
Status verified
Dec 2024
Primary completion
Jun 21, 2023
Completion
Oct 8, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab)
    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.

Primary Outcome Measure

Proportion of Overall Cutaneous Responders at Their 9th or Final Cycle (Cutaneous Complete Response [CR], Cutaneous 90 Response [CR90] or Cutaneous Partial Response [PR]) [ Time Frame: 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-

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Mayo Clinic in Florida· Jacksonville, FL

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