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

Completed · Phase 1

Conditions studied: Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

In brief

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.

Key facts

Study ID

NCT03340766

Run by

Amgen

People needed

31

Starts

2018-03-16

Expected to finish

2023-08-14

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Darlinghurst, New South Wales, Australia
• Research Site — St Leonards, New South Wales, Australia
• Research Site — Adelaide, South Australia, Australia
• Research Site — East Melbourne, Victoria, Australia
• Research Site — Geelong, Victoria, Australia
• Research Site — Melbourne, Victoria, Australia
• Research Site — Murdoch, Western Australia, Australia
• Research Site — Créteil, France
• Research Site — Nantes, France
• Research Site — Pierre-Bénite, France
• Research Site — Heidelberg, Germany
• Research Site — Ulm, Germany
• Research Site — Würzburg, Germany
• Research Site — Maastricht, Netherlands
• Research Site — Rotterdam, Netherlands
• Research Site — Santander, Cantabria, Spain
• Research Site — Salamanca, Castille and León, Spain
• Research Site — Barcelona, Catalonia, Spain
• Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

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