Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
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|ClinicalTrials.gov Identifier: NCT03184558|
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer Inflammatory Breast Cancer Stage IV||Drug: Bemcentinib; pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Extension to Simon's 2-stage design allowing termination at the end of Stage 1 for either futility or efficacy.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multi Centre Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated, Locally Advanced and Unresectable or Metastatic Triple Negative Breast Cancer (TNBC) or Triple Negative Inflammatory Breast Cancer (TN-IBC)|
|Actual Study Start Date :||July 26, 2017|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||August 30, 2018|
Experimental: Bemcentinib (BGB324) + pembrolizumab
Bemcentinib (BGB324) in combination with pembrolizumab. Bemcentinib capsules are administered at 400mg on days 1-3, and 200mg there after. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
Drug: Bemcentinib; pembrolizumab
Bemcentinib is a selective Axl kinase inhibitor; pembrolizumab is a PD-1 inhibitor.
Other Name: BGB324; Keytruda
- Objective Response Rate [ Time Frame: The disease response is the best improvement or change in a patient's cancer burden, as measured from baseline (screening) and then measured again at regular intervals over the whole period of the study, an average of 24 months. ]Objective Response Rate includes all patients whose cancer has a partial or complete response.
- Disease Control Rate [ Time Frame: Disease response is assessed every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression (worsens) or study completion, an average of 24 months. ]Disease Control Rate includes all patients who have a partial or complete response, or who maintain stable disease.
- Duration of Response [ Time Frame: Disease response is assessed every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression or study completion, an average of 24 months. ]Duration of Response includes patients with a partial or complete response and is measured from the date of response until the cancer progresses (worsens).
- Time to Progression [ Time Frame: Disease assessments are conducted at screening and then every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression or death, whichever comes first, up to study completion (an average of 24 months). ]Time to Progression is measured from the date of first dose to the date the cancer progresses (worsens) and includes all patients.
- Overall Survival [ Time Frame: Survival visits are conducted every 12 weeks after disease progression until death or until study completion (an average of 24 months). ]Overall Survival is measured from the date of first dose to the date of death or the date the patient is last known to be alive. It includes all patients.
- Number of patients with Adverse Events (as assessed by CTCAE v4.03) [ Time Frame: Adverse Events are recorded from the date of consent until up to 120 days after cessation of both treatments ]The number of patients with each Adverse Event will be summarised.
- Correlation of Response Rate with baseline biomarkers [ Time Frame: The biomarkers are collected at screening; the response rate is the best improvement or change in a patient's cancer burden, as measured from baseline (screening) and then again at regular intervals, over the whole study (an average of 24 months). ]Biomarkers (Axl kinase and PD-L1 expression) will be measured at screening using a diagnostic test. The Response Rate will be summarised according to Biomarker status (positive or negative) and includes all patients.
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): NCT03184558