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Imiquimod + Pembrolizumab for Skin Cancer
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial studies the side effects and efficacy of imiquimod and pembrolizumab in treating patients with stage IIIB-IV melanoma.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of response
Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.0
Overall survival
+2 moreSecondary outcome measures
Biomarker changes during 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
Pembrolizumab
FDA approved
Biopsy
2014
Completed Phase 4
~1090
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Imiquimod
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,242 Previous Clinical Trials
3,773,942 Total Patients Enrolled
41 Trials studying Melanoma
2,546 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,357 Total Patients Enrolled
559 Trials studying Melanoma
195,435 Patients Enrolled for Melanoma
Yiyi Yan, M.D., Ph.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I haven't used any experimental treatments or devices for my cancer in the last 4 weeks.Women who can have children must have a negative pregnancy test.I am currently breastfeeding.I have had pneumonitis treated with steroids or have it now.I have been treated for an autoimmune disease in the last 2 years.I have had a heart attack in the last 6 months or have heart failure needing constant treatment.I have an active tuberculosis infection.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or have recovered from their side effects.I have not received a live vaccine in the last 30 days.I am currently on medication for an infection.I have not been treated with pembrolizumab or similar drugs for my metastatic disease.I am willing to provide a tissue sample from my skin lesion for testing.I have an active hepatitis B or C infection.I am of childbearing age and do not plan to use birth control.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment or fully recovered from its side effects in the last 2 weeks.My cancer is at a stage that cannot be removed by surgery.You have a disease that can be measured using specific guidelines.I have been diagnosed with HIV.My cancer has spread to my brain or spinal cord.I have a skin lesion that can be treated with a cream.Your blood tests should show normal levels of white blood cells, platelets, hemoglobin, and certain other substances in your blood.I have another cancer besides the one being treated, which has gotten worse or needs treatment.You are allergic to pembrolizumab or any of its ingredients.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, imiquimod)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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