Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Condition: Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Blinatumomab; Pembrolizumab
Intervention description: Up to 2 cycles of blinatumomab may be given, where cycle 1 lasts 8 weeks, and cycle 2 lasts 28 days. The treatment is given as a continuous intravenous infusion.; One cycle of pembrolizumab is a 200 mg IV injection lasting 30 minutes. One cycle will be given every 3 weeks until disease progression, or for a maximum of 35 cycles.
Intervention MeSH terms: Pembrolizumab; Blinatumomab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: DLBCL Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Antibodies; Bispecific in combination with PD-1/PD-L1 inhibitor

Summary:

      The primary objective of the study is to determine the maximum tolerated dose (MTD) of
      blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r)
      DLBCL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically confirmed diffuse large B-cell lymphoma that is either:

          -  Refractory after at least one regimen of systemic chemotherapy and/or targeted
             therapy, or

          -  In first or later relapse if have received at least 2 systemic regimens since time of
             diagnosis, or

          -  Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
             with adequate organ function after proximity to transplantation time exclusions

          -  Have measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Life expectancy of ≥ 12 weeks in the opinion of the Investigator

          -  Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL)

        Other Inclusion Criteria May Apply

        Exclusion Criteria:

          -  Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic
             leukemia) or primary mediastinal B cell lymphoma (PMBCL)

          -  History or presence of clinically relevant central nervous system pathology such as
             epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's
             disease, cerebellar disease, organic brain syndrome, or psychosis.

          -  Has a diagnosis of immunodeficiency or has received systemic steroid therapy (in
             excess of 10 mg daily of prednisone equivalent) or any other form of immunosuppressive
             therapy within 7 days prior to the first dose of protocol specified therapy.

          -  Has undergone prior allogeneic HSCT:

          -  within the last 5 years OR

          -  greater than 5 years ago but has active graft versus host disease (GvHD) requiring
             systemic treatment.

          -  Has received autologous HSCT within 6 weeks prior to start of treatment.

        Other Exclusion Criteria May Apply.