Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab (KEYNOTE-348)
Trial Status: Active
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
- 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)
- 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.
University of California San Diego
Medical University of South Carolina
Trial Phase Phase I
Trial Type Treatment
- Primary ID 20150290
- Secondary IDs NCI-2017-02247, 2016-002191-27
- Clinicaltrials.gov ID NCT03340766