Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03222856
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2017-07-13
Brief Title:
Ph II Study of Pembrolizumab Eribulin in Patients With HRHER2- MBC Previously Treated With Anthracyclines Taxanes
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
A Phase II Study of Pembrolizumab and Eribulin in Patients With HR-positiveHER2-negative Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
Status:
COMPLETED
Status Verified Date:
2022-06
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:
KELLY
Brief Summary:
This a multicenter open-label phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-HRpositiveHER2-negative metastatic breast cancer MBC previously treated with at least one but not more than two prior chemotherapeutic regimens for treatment of locally recurrent andor metastatic disease Prior therapy must have included an anthracycline and a taxane and prior anti-hormonal therapy is mandatory
The number of patients to be included is 44 patients at 11 sites All eligible patients will be treated with MK3475 pembrolizumab 200 mg on day 1 of each 21-day cycle and eribulin 123 mgm2 equivalent to eribulin mesylate at 14 mgm2 on days 1 and 8 of every 21-day cycle
The number of patients to be included is 44 patients at 11 sites All eligible patients will be treated with MK3475 pembrolizumab 200 mg on day 1 of each 21-day cycle and eribulin 123 mgm2 equivalent to eribulin mesylate at 14 mgm2 on days 1 and 8 of every 21-day cycle
Detailed Description:
This a multicenter open-label phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-HRpositiveHER2-negative metastatic breast cancer MBC previously treated with at least one but not more than two prior chemotherapeutic regimens for treatment of locally recurrent andor metastatic disease Prior therapy must have included an anthracycline and a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient Prior anti-hormonal therapy is mandatory
The number of patients to be included is 44 patients at 11 sites The primary objective is to assess the efficacy -as determined by the clinical benefit rate CBR total number of objective responses plus stable disease for at least 24 weeks based on RECIST v11- of MK3475 pembrolizumab in combination with eribulin
Primary endpoint is CBR based on RECIST v11 All eligible patients will be treated with MK3475 pembrolizumab 200 mg on day 1 of each 21-day cycle and eribulin 123 mgm2 equivalent to eribulin mesylate at 14 mgm2 on days 1 and 8 of every 21-day cycle Treatment with MK3475 pembrolizumab and eribulin will continue based on physician criteria No maximum duration of treatment is specified Study follow-up will be performed 12 months after last study dose
Available tumor tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy since last progression of a metastatic tumor lesion not previously irradiated is requested for this study
Translational research of this protocol involves the collection processing temporary storage and shipment of samples from consenting patients enrolled in centers selected for participation in the study The study plan includes collection and initial processing of tumor tissues and blood samples to the central laboratory of Institut Hospital del Mar dInvestigacions Mediques IMIM that will be used to identify dynamic biomarkers that may be predictive of response to MK3475 pembrolizumab and eribulin treatment
The number of patients to be included is 44 patients at 11 sites The primary objective is to assess the efficacy -as determined by the clinical benefit rate CBR total number of objective responses plus stable disease for at least 24 weeks based on RECIST v11- of MK3475 pembrolizumab in combination with eribulin
Primary endpoint is CBR based on RECIST v11 All eligible patients will be treated with MK3475 pembrolizumab 200 mg on day 1 of each 21-day cycle and eribulin 123 mgm2 equivalent to eribulin mesylate at 14 mgm2 on days 1 and 8 of every 21-day cycle Treatment with MK3475 pembrolizumab and eribulin will continue based on physician criteria No maximum duration of treatment is specified Study follow-up will be performed 12 months after last study dose
Available tumor tissue for PD-L1 biomarker analysis from a newly obtained core or excisional biopsy since last progression of a metastatic tumor lesion not previously irradiated is requested for this study
Translational research of this protocol involves the collection processing temporary storage and shipment of samples from consenting patients enrolled in centers selected for participation in the study The study plan includes collection and initial processing of tumor tissues and blood samples to the central laboratory of Institut Hospital del Mar dInvestigacions Mediques IMIM that will be used to identify dynamic biomarkers that may be predictive of response to MK3475 pembrolizumab and eribulin treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004513-27 | EUDRACT_NUMBER | None | None |