Pembrolizumab and Imatinib in Patients With Locally Advanced/Metastatic Melanoma With c-KIT Mutation/Amplification
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|ClinicalTrials.gov Identifier: NCT02812693|
Recruitment Status : Withdrawn (poor accrual)
First Posted : June 24, 2016
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIA Skin Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma||Drug: Imatinib Mesylate Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 1 Phase 2|
I. To assess the best overall response rate (BORR = complete response + partial response) of the combination of pembrolizumab and imatinib for treatment of melanomas harboring c-Kit mutation or amplification.
II. To evaluate the safety and adverse effect profile of the combination of pembrolizumab and imatinib in patients with melanomas harboring c-KIT aberrations (mutations or amplifications).
I. To assess the median time to progression (TTP), progression free survival (PFS), and overall survival (OS).
I. Assessment of programmed cell death ligand (PD-L)1 expression in melanoma patients with c-KIT aberrations before and after combined therapy.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and imatinib mesylate orally (PO) once daily (QD) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and every 9 weeks for 1 year, and then every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Trial of Pembrolizumab in Combination With Imatinib in Patients With Locally Advanced or Metastatic Melanoma With c-KIT Mutation or Amplification|
|Actual Study Start Date :||November 4, 2016|
|Actual Primary Completion Date :||November 20, 2017|
|Actual Study Completion Date :||November 20, 2017|
Experimental: Treatment (pembrolizumab, imatinib)
Patients receive pembrolizumab IV over 30 minutes on day 1 and imatinib mesylate orally PO QD on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Imatinib Mesylate
Other: Laboratory Biomarker Analysis
- BORR [ Time Frame: Up to 4 years ]Will be estimated with a 95% exact confidence interval.
- Change in PD-1 and PDL-1 expression levels [ Time Frame: Baseline to 4 years ]Will be performed by estimating the 95% confidence interval for the difference in PD-1 and PDL-1 expression levels, respectively. Descriptive statistics and graphical displays will be used to evaluate change in biologic markers between pre- and post-treatment. A paired t-test will be used to determine if there is a statistically significant change.
- Incidence of adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 4 years ]Will be assessed by computing the proportion of patients with adverse events, along with an exact 95% confidence interval.
- OS [ Time Frame: From registration until death from any cause, assessed up to 4 years ]The distribution will be assessed using the Kaplan Meier method.
- PFS [ Time Frame: From registration until disease progression or death, assessed up to 4 years ]Distribution of PFS time will be estimated using the method of Kaplan Meier.
- TTP [ Time Frame: From registration until disease progression or death, assessed up to 4 years ]Will be estimated using a Kaplan-Meier method.
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): NCT02812693
|Principal Investigator:||Joanne Jeter, MD||Ohio State University Comprehensive Cancer Center|