For Healthcare Professionals

Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Have histologically confirmed diffuse large B-cell lymphoma that is either:
  2. Refractory after at least one regimen of systemic chemotherapy and/or targeted therapy, or
  3. In first or later relapse if have received at least 2 systemic regimens since time of diagnosis, or
  4. Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT) with adequate organ function after proximity to transplantation time exclusions
  5. Have measurable disease
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  7. Life expectancy of ≥ 12 weeks in the opinion of the Investigator
  8. Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL) Other Inclusion Criteria May Apply

EXCLUSION CRITERIA

  1. Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic leukemia) or primary mediastinal B cell lymphoma (PMBCL)
  2. 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.
  3. 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.
  4. Has undergone prior allogeneic HSCT:
  5. within the last 5 years OR
  6. greater than 5 years ago but has active graft versus host disease (GvHD) requiring systemic treatment.
  7. Has received autologous HSCT within 6 weeks prior to start of treatment. Other Exclusion Criteria May Apply.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 866-572-6436Email iconEmail Study Center

Study’s details


Contition

Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Age (in years)

18 - 100

Phase

Phase 1

Participants needed

31

Est. Completion Date

Aug 2023

Treatment type

Interventional


Sponsor

Amgen

ClinicalTrials.gov identifier

NCT03340766

Study number

20150290

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