InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

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


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.


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


Blood Cancers Haematological


People18 - 100



Trial Acronym


More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor


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)



  • 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


  • 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.


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


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

Clinical trials have complex eligibility criteria.

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

Participating hospitals

+ Show non-recruiting hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support


Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more


Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more


Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.


Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.