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.