Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer
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|ClinicalTrials.gov Identifier: NCT03463460|
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thymic Carcinoma||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Drug: Sunitinib Malate||Phase 2|
I. To evaluate the efficacy of pembrolizumab and sunitinib malate (sunitinib) for the treatment of patients with thymic carcinoma that have progressed on prior platinum based chemotherapy as measured by objective response rate.
I. To evaluate the safety profile and toxicity of combination pembrolizumab and sunitinib malate as per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0.
II. To evaluate the progression free survival (PFS) and overall survival (OS) of patients treated with combination pembrolizumab and sunitinib.
I. To determine objective response rate (ORR), PFS, and OS by PD-L1 expression > 50% tumor proportion score (TPS) (by 22C3 assay) II. To determine whether sunitinib treatment leads to increase in PD-L1 expression and tumor infiltrating lymphocytes and decrease in myeloid-derived suppressor cells (MDSC) in both tumor and peripheral blood.
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and sunitinib malate orally (PO) daily on days 1-14. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
After completion of the study treatment, participants are followed up for 30 days, every 6 weeks for 1 year, and every 9 or 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Phase II Trial of Pembrolizumab and Sunitinib in Refractory Advanced Thymic Carcinoma|
|Actual Study Start Date :||June 19, 2018|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: Treatment (pembrolizumab, sunitinib malate)
Participants receive pembrolizumab IV over 30 minutes on day 1 and sunitinib malate PO daily on days 1-14. Courses repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Sunitinib Malate
- Response defined by a complete response (CR) or partial response (PR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 24 months ]Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. Exact binomial 95% confidence intervals for the true PR + CR response rate will be calculated.
- Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after the last dose of treatment ]Frequency and severity of adverse events and tolerability of the regimen in each of the treatment arms will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Events will be summarized based on frequency and proportion of total subjects, by system organ class and preferred term. Separate summaries with descriptive statistics (counts, percentage, mean, standard deviation, etc.) will be given for all AEs, treatment-related AEs, AEs by toxicity grade, serious adverse events and AEs leading to discontinuation of study treatment and dose modification. The incidence of deaths and the primary cause of death will be summarized.
- Overall survival (OS) [ Time Frame: From study registration up to 24 months ]OS is defined as the duration from study registration to death due to any cause, whichever comes first. Patients last known to be alive will be censored at the date of last contact.
- Progression free survival (PFS) [ Time Frame: From study registration up to 24 months ]PFS is defined as the duration from study registration to progression, symptomatic deterioration, or death due to any cause, whichever comes first. Patients last known to be alive and progression-free will be censored at the date of [last contact or disease assessment]. PFS will be defined on patients with both measurable and non-measurable disease.
- PD-L1 by immunohistochemistry [ Time Frame: Up to 24 months ]22C3 assay will be used, reported as tumor proportion score (TPS)% from 0-100%). It will be assessed how PD-L1 expression levels correspond with achievement of response to treatment. PD-L1 level will be assessed as both a continuous variable and dichotomized (less than or greater than 50% TPS expression).
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): NCT03463460
|Contact: The Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Gwen Christenson||614-346-7964||Gwen.Christenson@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Dwight H. Owen, MD 614-685-2039 Dwight.firstname.lastname@example.org|
|Principal Investigator: Dwight H. Owen, MD|
|Principal Investigator:||Dwight Owen, MD||Ohio State University Comprehensive Cancer Center|