Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT03276832
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Metastatic Melanoma
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7

Eligibility Criteria

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

Interventions

  • Imiquimod — DRUG
    Applied cutaneously
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This pilot early phase I trial studies the side effects and how well imiquimod and pembrolizumab work in treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system. 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. Giving imiquimod and pembrolizumab may work better at treating melanoma.

Key Dates

Start date
Dec 20, 2017
Status verified
Oct 2025
Primary completion
Oct 15, 2019
Completion
Oct 15, 2019

Study Design

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

Arms

  • Experimental: Treatment (pembrolizumab, imiquimod)
    Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Cycles repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy at baseline, 6 weeks, and 12 weeks and CT, PET/CT, or MRI throughout the trial.

Primary Outcome Measure

Duration of Response [ Time Frame: 16 months ]

Locations (1)

FacilityCityStateZIP
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980

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By specialty
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By research site
Mayo Clinic in Florida· Jacksonville, FL

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