Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03276832|
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : January 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7||Drug: Imiquimod Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Early Phase 1|
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.
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.
Patients receive pembrolizumab intravenously (IV) on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Courses repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study to Test the Safety and Efficacy of the Combination of Imiquimod and Pembrolizumab for the Treatment of Metastatic Melanoma|
|Actual Study Start Date :||December 20, 2017|
|Estimated Primary Completion Date :||February 15, 2021|
|Estimated Study Completion Date :||February 15, 2021|
Experimental: Treatment (pembrolizumab, imiquimod)
Patients receive pembrolizumab IV on day 1 and apply imiquimod cutaneously on days 1-5 (Monday - Friday). Courses repeat every 21 days for up to 2 years (approximately 35 courses) in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Duration of response [ Time Frame: From registration to disease progression, assessed up to 2 years ]Will be estimated using the Kaplan-Meier method.
- Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]For each type of toxicity reported, the proportion of patients experiencing a severe level of that toxicity will be determined.
- Overall survival [ Time Frame: From registration to death due to any cause, assessed up to 2 years ]Will be estimated using the Kaplan-Meier method.
- Progression free survival [ Time Frame: From registration to documentation of first disease progression or death due to any cause, assessed up to 2 years ]Will be estimated using the Kaplan-Meier method.
- 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 [ Time Frame: Up to 2 years ]If there are no tumor responses documented among these 10 patients, then upper bound of a one-sided 95% confidence interval for the tumor response rate would be 25.9%.
- Biomarker changes during treatment [ Time Frame: Baseline up to 12 weeks ]For each patient and each biomarker, a times-series plot of biomarker value will be constructed. These graphs will be visually examined for trends within and between the group of patients whose tumor responded to treatment and the group of patients whose tumor did not respond to treatment. Will include assessing total tumor RNA through RNA seq and PDL1 expression through the use of immunohistochemistry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276832
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Richard W. Joseph|
|Principal Investigator:||Richard Joseph||Mayo Clinic|