Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-26 @ 11:42 PM
Study NCT ID:
NCT03276832
Status:
COMPLETED
Last Update Posted:
2025-10-28
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Pilot Study to Test the Safety and Efficacy of the Combination of Imiquimod and Pembrolizumab for the Treatment of Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVES:
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.
CORRELATIVE RESEARCH OBJECTIVES:
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.
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.
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.
CORRELATIVE RESEARCH OBJECTIVES:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: