What side effects are associated with this type of intervention?

Common treatments for melanoma, such as imiquimod and pembrolizumab, have distinct side effect profiles. Imiquimod often causes local skin reactions including redness, swelling, and irritation. Pembrolizumab, a monoclonal antibody, can lead to immune-related adverse events such as skin reactions, endocrine disorders, and more severe conditions like pneumonitis, colitis, and hepatitis. Combining these treatments can enhance the immune response but also increases the risk of compounded side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma that involve immune system stimulation and monoclonal antibody immunotherapy. Pembrolizumab, a PD-1 inhibitor, has been approved for advanced melanoma and has shown efficacy in various clinical trials, including KEYNOTE-006. Another similar drug, Nivolumab, also a PD-1 inhibitor, has been approved for melanoma and is often used in combination with Ipilimumab, a CTLA-4 inhibitor, to enhance immune response. Imiquimod, although not as commonly used for advanced melanoma, is approved for superficial skin cancers and works by stimulating the immune system to attack cancer cells. These treatments represent significant advancements in melanoma therapy by leveraging the body's immune system to combat cancer.

What other types of research exist?

Promising alternatives to Imiquimod and Pembrolizumab for melanoma treatment in 2024 include: 1) Nivolumab plus Ipilimumab combination therapy, which has shown improved treatment-free survival in advanced melanoma. 2) Investigational agents being evaluated in clinical trials for treatment-refractory melanoma, which may offer new therapeutic options. Patients should discuss these options with their healthcare provider and consider enrolling in clinical trials.

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Imiquimod + Pembrolizumab for Skin Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for melanoma, such as imiquimod and pembrolizumab, work by harnessing the body's immune system to fight cancer. Imiquimod stimulates the immune system, helping it to recognize and attack melanoma cells. Pembrolizumab, a monoclonal antibody, targets the PD-1 receptor on T cells, preventing melanoma cells from evading immune detection. This dual approach is significant for melanoma patients as it enhances the immune system's ability to combat the cancer, potentially leading to better treatment outcomes.

Phase < 1

Waitlist Available

Led By Yiyi Yan, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have received prior pembrolizumab or other anti-PD1/PDL1 therapies for their metastatic disease

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Must not have

Uncontrolled intercurrent illness including 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial studies the effects of combining imiquimod and pembrolizumab to treat advanced melanoma. Imiquimod boosts the immune system, and pembrolizumab helps the immune system attack cancer cells. Pembrolizumab is a standard treatment for advanced melanoma, and imiquimod has shown promise in treating melanoma metastases. The goal is to see if this combination works better than current treatments.

Who is the study for?

This trial is for patients with stage IIIB-IV melanoma who haven't had pembrolizumab or similar therapies for metastatic disease. They must have a treatable skin lesion, confirmed diagnosis not suitable for surgery, good performance status and lab values, no severe diseases that could interfere with the trial, no active infections or certain heart conditions, and be willing to use contraception.

What is being tested?

The study tests how well imiquimod (which stimulates the immune system) combined with pembrolizumab (an antibody that may stop tumor growth) treats advanced melanoma. It's a pilot trial to see if this combination works better than current treatments.

What are the potential side effects?

Possible side effects include reactions related to stimulating the immune system which can cause inflammation in various organs, infusion-related reactions from pembrolizumab administration, fatigue, potential blood disorders and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not been treated with pembrolizumab or similar drugs for my metastatic disease.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is at a stage that cannot be removed by surgery.

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I have a skin lesion that can be treated with a cream.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I haven't used any experimental treatments or devices for my cancer in the last 4 weeks.

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I am currently breastfeeding.

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I have had pneumonitis treated with steroids or have it now.

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I have been treated for an autoimmune disease in the last 2 years.

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I am currently on medication for an infection.

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I have had a heart attack in the last 6 months or have heart failure needing constant treatment.

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I have an active tuberculosis infection.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.

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I have an active hepatitis B or C infection.

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I am of childbearing age and do not plan to use birth control.

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I haven't had cancer treatment or fully recovered from its side effects in the last 2 weeks.

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I have been diagnosed with HIV.

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My cancer has spread to my brain or spinal cord.

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I have another cancer besides the one being treated, which has gotten worse or needs treatment.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of response

Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.0

Overall survival

+2 more

Secondary study objectives

Biomarker changes during treatment

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, imiquimod)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Pembrolizumab

FDA approved

Computed Tomography

2017

Completed Phase 2

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Imiquimod

FDA approved

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for melanoma, such as imiquimod and pembrolizumab, work by harnessing the body's immune system to fight cancer. Imiquimod stimulates the immune system, helping it to recognize and attack melanoma cells. Pembrolizumab, a monoclonal antibody, targets the PD-1 receptor on T cells, preventing melanoma cells from evading immune detection. This dual approach is significant for melanoma patients as it enhances the immune system's ability to combat the cancer, potentially leading to better treatment outcomes.