NCT03276832

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

Pilot Study to Test the Safety and Efficacy of the Combination of Imiquimod and Pembrolizumab for the Treatment of Metastatic Melanoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To gain preliminary data of the anti-tumor activity and safety profile of the combination of imiquimod and pembrolizumab in patients with unresectable cutaneous melanoma. CORRELATIVE RESEARCH OBJECTIVES: I. To compare and contrast (in a hypothesis generating manner) the biomarker profiles of patients who have a confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) criteria with patients who do not. OUTLINE: Patients receive pembrolizumab intravenously (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 computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up every 12 weeks for 1 year and then every 6 months for up to 3 years after registration.

Conditions

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

Interventions

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

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-10-15
• Completion: 2019-10-15
• First posted: 2017-09-08
• Last updated: 2026-03-19
• Results posted: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study