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 |
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
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.
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