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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

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)

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.

California

San Diego
University of California San Diego
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: IN_REVIEW

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Amgen, Inc.

  • Primary ID 20150290
  • Secondary IDs NCI-2017-02247, 2016-002191-27
  • Clinicaltrials.gov ID NCT03340766