MK-3475 in Melanoma and NSCLC Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT02085070|
Recruitment Status : Recruiting
First Posted : March 12, 2014
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non-Small Cell Lung Cancer Brain Metastases||Drug: MK-3475||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of MK-3475 in Patients With Metastatic Melanoma and Non-Small Cell Lung Cancer With Untreated Brain Metastases|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2018|
U.S. FDA Resources
Experimental: Melanoma patients
After establishing eligibility criteria, for patients with melanoma the investigator will determine at least one lesion that requires local therapy (surgical resection or LITT) based on size, location, and/or risk of hemorrhage; this will be considered the "surgical lesion". All other eligible brain lesions will be considered "clinically evaluable lesions" and will be followed by modified RECIST (mRECIST) criteria to determine best response.
Non-small cell lung cancer patients
NSCLC patients are not required to have a "surgical lesion" but must have at least one "clinically evaluable lesion" in the central nervous system. Patients on NSCLC are required to have formalin-fixed, paraffin-embedded tumor tissue available for biomarker analysis.
- Response will be evaluated after systemic therapy [ Time Frame: 8 weeks ]Response will be evaluated after 8 weeks of systemic therapy and then every 8 weeks thereafter. The purpose of the 4 weeks scans is to determine safety. If sysmptoms develop or clinical deterioration occurs, patients may be imaged prior to the pre-specified time points for imaging. All responses must be confirmed by repeat imaging at least 4 weeks following initial documentation of objective response.
- Brain metastases response assessment [ Time Frame: 28 days ]RECIST criteria v1.1 will be modified to account for differences in measuring the response of clinically evaluable brain lesions as opposed to systemic lesions (modified RECIST, or mRECIST). Size is considered the tumor's largest diameter. Measurements from multiple lesions are summed to calculate the sum of the diameters (SD). The SD calculated on a baseline scan performed within 28 days of study drug initiation will be used as a reference to determine the objective response of the clinically evaluable lesions. All responses must be confirmed at 4 weeks with an equivalent or better response. Please refer to the original RECIST criteria if further reference is necessary.
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): NCT02085070
|United States, Connecticut|
|Smilow Cancer Center at Yale New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Harriet Kluger, MD 203-737-2572 email@example.com|
|Principal Investigator: Harriet Kluger, MD|
|Sub-Investigator: Veronica Chiang, MD|
|Sub-Investigator: Sarah Goldberg, MD|
|Sub-Investigator: Roy Herbst, MD|
|Sub-Investigator: Mario Sznol, MD|
|Sub-Investigator: Scott Gettinger, MD|
|Sub-Investigator: Anne Chiang, MD|
|Sub-Investigator: Rogerio Lilenbaum, MD|
|Principal Investigator:||Harriet Kluger, MD||Yale University|