MK-3475 as Maintenance Therapy in Extensive Stage SCLC
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02359019|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2015
Results First Posted : October 26, 2020
Last Update Posted : July 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Extensive Stage Small Cell Lung Carcinoma||Biological: Pembrolizumab Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined progression-free survival (PFS) in extensive stage small cell lung cancer (SCLC) patients, who have complete response (CR), partial response (PR) or stable disease following minimum of 4 cycles of platinum (cisplatin or carboplatin) and etoposide.
I. To assess modified PFS in all patients enrolled. II. To assess overall survival of patients enrolled on the trial. III. To assess programmed cell death 1 ligand 1 (PD-L1) expression in archival tumor tissues and in circulating tumor cells (CTCs) and correlate the expression to RECIST defined PFS.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of MK-3475 as Maintenance Therapy in Extensive Stage Small Cell Lung Cancer (SCLC) Patients|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||September 2022|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- PFS Using RECIST 1.1 [ Time Frame: Time from registration to time of progression, assessed up to 6 months after completion of study treatment. ]Progression is defined using RECIST 1.1. PFS will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of PFS will be calculated.
- Modified PFS Defined by RECIST as Progression That is Confirmed by a Second Scan at Least 4 Weeks Apart [ Time Frame: Time from registration to time of progression, assessed up to 6 months after completion of study treatment. ]Progression is defined using RECIST 1.1. Estimated using standard Kaplan-Meier methods, from which the median and a 90% confidence interval will be calculated.
- Overall Survival [ Time Frame: Time from registration to time of death, assessed up to 12 months after completion of study treatment. ]Estimated using standard Kaplan-Meier methods, from which the median and a 95% confidence interval will be calculated.
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): NCT02359019
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Ammar Sukari||Barbara Ann Karmanos Cancer Institute|