Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab (KEYNOTE-348)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:2/3/2019
Start Date:March 16, 2018
End Date:October 5, 2024
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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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) (KEYNOTE-348)

Phase 1b: To determine the maximum tolerated dose (MTD) of blinatumomab in combination with
pembrolizumab in adult subjects with relapsed or refractory (r/r) DLBCL


Inclusion Criteria:

- Have histologically confirmed Diffuse Large B Cell Lymphoma that is either:

- Refractory to first or later treatment, or

- First or later relapse AND has received at least 2 prior therapies (one of which
can be frontline therapy) or

- Relapsed post-autologous HSCT

- Have measureable disease

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Life expectancy of ≥ 12 weeks in the opinion of the Investigator

- Subject must be able to provide an evaluable core or excisional biopsy prior to the
start of treatment. 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 is receiving systemic steroid therapy (in
dosing exceeding 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.
We found this trial at
3
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Darlinghurst,
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Charleston, South Carolina 29412
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Charleston, SC
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Greenville, South Carolina 29605
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Greenville, SC
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