Overview

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

Status:
Active, not recruiting
Trial end date:
2025-01-31
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Antibodies, Bispecific
Blinatumomab
Pembrolizumab
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 HSCT with adequate organ function after
proximity to transplantation time exclusions as specified in Exclusion Criteria 208
and 209

- Have measureable 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.