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CompletedLast updated: 7 February 2024

KEYNOTE-348: This phase I trial is combining a new drug (blinatumomab) with a commonly used immunotherapy drug (pembrolizumab) for the treatment of relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL)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)

Clinical summary

Summary

In this trial, participants will be allocated to one of seven cohorts. Treatment commencement will be dependent on the cohort to which the participant is allocated. The aim of this trial is to determine the maximum tolerated dose of blinatumomab, so participants will receive varying doses between cohorts.

Conditions

This trial is treating patients with Diffuse Large B-Cell Lymphoma (DLBCL).

Cancer

Blood Cancers Haematological

Age

People18 - 100

Phase

I

Trial Acronym

KEYNOTE-348

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

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)

Eligibility

Inclusion

  • 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 hematopoietic stem cell transplantation (HSCT) with adequate organ function after proximity to transplantation time exclusions
  • Have measurable 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

  • 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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