Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC (NCT03184558) | Clinical Trial Compass
TerminatedPhase 2
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
Stopped: Based on planned futility assessment
United States29 participantsStarted 2017-07-26
Plain-language summary
This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in participants with previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The primary objective is objective response rate.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed informed consent.
✓. Male and non-pregnant females who are aged 18 years or older at the time of provision of informed consent.
✓. Histopathologically or cytologically documented TNBC or TN-IBC. Tumors must have been confirmed negative for ER and partial response (PR) by immunohistochemistry (IHC) (\<1% positive tumor nuclei, as per ASCO-CAP guideline recommendations) and negative for human epidermal growth factor receptor 2 (HER2) by IHC or fluorescent or chromogenic in situ hybridization (FISH or CISH). Patients with equivocal HER2 results by IHC should have their negativity status confirmed by FISH.
✓. Locally advanced and unresectable or metastatic TNBC or triple negative inflammatory breast cancer.
✓. Received one or more prior therapies for TNBC or inflammatory breast cancer in the metastatic setting, and prior treatment (metastatic or (neo) adjuvant) must have included a prior taxane and/or anthracycline-based therapy.
✓. Has measurable disease as defined by RECIST 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) and as determined by the site study team. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Provision of suitable tumor tissue for the analysis of Axl kinase expression and PD-L1 expression.
✓. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
Exclusion criteria
✕. Has disease that is suitable for local therapy administered with curative intent.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Until disease progression or death or withdrawal of consent whichever comes first, up to end of study (Up to 1 year)
✕. More than 3 previous lines of therapy in the metastatic setting.
✕. Has received prior therapy with an immunomodulatory agent.
✕. Has a known additional malignancy that is progressing or requires active treatment. Note: Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. History of the following cardiac conditions:
✕. Abnormal left ventricular ejection fraction on echocardiography or Multi Gated Acquisition Scan (MUGA) (less than the lower limit of normal for a patient of that age at the treating institution or \<45%, whichever is lower).
✕. Current treatment with any agent known to cause Torsades de Pointes which cannot be discontinued at least five half-lives or two weeks prior to the first dose of study treatment.