A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in combination with Pembrolizumab in Adult Subjects with Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Completed

Conditions: Kanker in de bloedcellen
Cancer
Lymphoma
Non-Hodgkins Lymphoma

Registration Number: NL-OMON49694

Lead Sponsor: Amgen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

This study seeks to enroll adult subjects with histologically confirmed Diffuse
Large B Cell Lymphoma that is either:
-refractory after at least one regimen of systemic chemotherapy and/or targeted
therapy, and refractory is defined as progressive or stable disease as the best
response to the most recent systemic chemotherapy regimen or disease
progression or relapse within 12 months after autologous stem cell
transplantation; when using PET for assessment, for subjects with refractory
disease and who have received radiotherapy, PET positivity should be
demonstrated no less than 6 weeks after the last dose of radiotherapy (Crump et
al, 2017; Neelapu et al, 2017; Cheson et al, 2007), or
-in first or later relapse if have received at least 2 systemic regimens since
time of diagnosis, or
-relapsed post autologous or allogeneic HSCT with adequate organ function after
proximity to transplantation time exclusions as specified in Exclusion Criteria
208 and 209.
For a full list of eligibility criteria, please refer to Section 4.1 and
Section 4.2

Exclusion Criteria

Subjects will be excluded if they have Richter's transformation (DLBCL arising
in the setting of
prior chronic lymphocytic leukemia) or Primary Mediastinal B cell Lymphoma
(PMBCL) or have
history or presence of clinically relevant central nervous system (CNS)
pathology such as
epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson*s
disease, cerebellar disease, organic brain syndrome, or psychosis or has
evidence of active, non-infectious
pneumonitis, or has a history of interstitial lung disease.
For a full list of eligibility criteria, please refer to Section 4.1 and
Section 4.2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> Incidence of dose limiting toxicities (DLTs)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Objective response (OR) (including CR and PR) by the Lugano Classification<br /><br>(Cheson et al, 2014) and Revised Response Criteria (Cheson et al, 2007)during<br /><br>the first 12 weeks since starting blinatumomab and during the treatment period<br /><br>• Complete response (CR) by the Lugano Classification (Cheson et al, 2014) and<br /><br>Revised Response Criteria (Cheson et al, 2007) during the first 12 weeks since<br /><br>starting blinatumomab and during the treatment period<br /><br>• Duration of response (DOR) for subjects with OR (ie, CR and partial remission<br /><br>(PR) by the Lugano Classification (Cheson et al, 2014) during the first 12<br /><br>weeks since starting blinatumomab)<br /><br>• Progression free survival (PFS)<br /><br>• Overall survival (OS)<br /><br>• Blinatumomab PK parameters<br /><br>• Pembrolizumab PK parameters</p><br>