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

NCT03276832 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: MC1578NCI-2017-0159116-002518
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Duration of Response

  Defined as the time from response to disease progression.

  16 months

• Incidence of Adverse Events (AEs)

  AEs are graded using Common Terminology Criteria for Adverse Events version 4.0

  16 months

• Overall Survival

  Defined as the time from registration to death due to any cause. Will be estimated using the Kaplan-Meier method. The 21 month OS rate was calculated here.

  21 months

• Progression Free Survival

  Defined as the time from registration to documentation of first disease progression or death due to any cause. Will be estimated using the Kaplan-Meier method. The 7 month PFS rate was calculated.

  7 months

• Tumor Response Rate

  Defined as percentage of patients whose objective disease status meets the criteria for Response Evaluation Criteria in Solid Tumors (RECIST) criteria for partial or complete response on two consecutive disease evaluations.

  16 months

Study Arms (1)

Treatment (pembrolizumab, imiquimod)

EXPERIMENTAL

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.

Drug: Imiquimod; Procedure: Biopsy; Biological: Pembrolizumab; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

Interventions

Imiquimod DRUG

Applied cutaneously

Also known as: Aldara, R 837, S 26308, Zyclara

Treatment (pembrolizumab, imiquimod)

Biopsy PROCEDURE

Undergo biopsy

Treatment (pembrolizumab, imiquimod)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (pembrolizumab, imiquimod)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan

Treatment (pembrolizumab, imiquimod)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (pembrolizumab, imiquimod)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, Nuclear Magnetic Resonance Imaging, NMRI, Structural MRI, sMRI

Treatment (pembrolizumab, imiquimod)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c that is not suitable for surgical resection
• Patients must not have received prior pembrolizumab or other anti-PD1/PDL1 therapies for their metastatic disease
• At least one cutaneous lesion that is amenable to treatment with topical imiquimod
• Measurable disease by RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Hemoglobin \> 9.0 g/dL or \>= 5.6 mmol/L without transfusion or (EPO) erythropoietin dependency (within 7 days of assessment)
• Serum total bilirubin =\< 1.5 X upper limit of normal (ULN) or direct bilirubin =\< (ULN) for subjects with total bilirubin levels \> 1.5 ULN
• Aspartate transaminase (AST) =\< 2.5 x ULN or =\< 5 x ULN for subjects with liver metastases
• Albumin \>= 2.5mg/dL
• International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
• Activated partial thromboplastin time (aPTT) =\< 1.5 ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
• Creatinine =\< 1.5 X upper limit of normal (ULN)
• NOTE: measured or calculated (per institutional standard) creatinine clearance is acceptable \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN

You may not qualify if:

• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• NOTE: female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year; male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; abstain from heterosexual activity is also acceptable method of contraception for males
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm or used an investigational device =\< 4 weeks from registration
• History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Known history of active TB (Bacillus tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients
• Prior anti-cancer monoclonal antibody (mAb) =\< 4 weeks prior to registration or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to registration
• Prior chemotherapy, targeted small molecule therapy, or radiation therapy =\< 2 weeks prior to registration or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
• Note: subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Melanoma

Interventions

Imiquimod; Biopsy; pembrolizumab; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Ruqin Chen, MD, MB
• Organization: Mayo Clinic Florida

chen.ruqin@mayo.edu

904-953-2000

Study Officials

• Ruqin Chen, MD, MB

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 8, 2017
• Study Start: December 20, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2025-10

Locations

US (1)