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Metastatic MelanomaEarly Phase 1NCT03276832

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

A Early Phase 1 study testing Imiquimod, Biopsy and Pembrolizumab in people with Metastatic Melanoma and Stage IIIB Cutaneous Melanoma AJCC v7, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Imiquimod, Biopsy and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
20 Dec 2017to 15 Oct 2019
Phase
Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Negative urine or serum pregnancy test done =< 72 hours prior to first treatment, for women of childbearing potential only
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up
  • Willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion in appropriate low risk cutaneous lesions
  • NOTE: if the tissue biopsy is deemed to be of increased risk for the patient, the biopsy should not be performed and is optional
  • NOTE: newly-obtained is defined as a specimen obtained up to 42 days prior to registration where no anti-cancer therapy after the specimen was obtained and registration

Who cannot join

  • 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
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  • 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
  • Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Known secondary malignancy that has progressed within the last 3 years or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Received a live vaccine =< 30 days prior to registration
  • Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImiquimodDrug

    Also called Aldara, R 837, S 26308, Zyclara

    Applied cutaneously

  • BiopsyProcedure or surgery

    Undergo biopsy

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo MRI

Study groups in NCT03276832
Study groupRoleWhat they receive
Treatment (pembrolizumab, imiquimod)ExperimentalPatients 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.
Receives: Drug: Imiquimod; Procedure: Biopsy; Biological: Pembrolizumab; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Response

    Defined as the time from response to disease progression.

    Measured: 16 months

  2. Incidence of Adverse Events (AEs)

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

    Measured: 16 months

  3. 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.

    Measured: 21 months

  4. 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.

    Measured: 7 months

  5. 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.

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2017
  2. Study start20 Dec 2017
  3. Primary completion15 Oct 2019
  4. Study completion15 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03276832
Sponsor's protocol ID
MC1578
Other IDs
NCI-2017-01591, MC1578, 16-002518
Status last verified
Oct 2025
First submitted
7 Sep 2017
Last updated
19 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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