Phase 1
Completed N=31
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Source: ClinicalTrials.gov NCT03340766 ↗Enrolled (actual)
31
Serious AEs
80.7%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) — 1; 0; 2 Participants
Summary
The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
1; 0; 2 | — |
| SECONDARY Objective Response Rate During the First 12 Weeks Using Revised Response Cheson Criteria |
16.7; 30.0; 33.3 | — |
| SECONDARY Cohort IIIa Only: Objective Response Rate During the First 12 Weeks Using the Lugano Classification |
11.1 | — |
| SECONDARY Objective Response Rate During the Treatment Period Using Revised Response Cheson Criteria |
25.0; 40.0; 33.3 | — |
| SECONDARY Cohort IIIa Only: Objective Response Rate During the Treatment Period Using the Lugano Classification |
11.1 | — |
| SECONDARY Complete Response Rate During the First 12 Weeks Using the Revised Response Cheson Criteria |
0.0; 20.0; 11.1 | — |
| SECONDARY Cohort IIIa Only: Complete Response Rate During the First 12 Weeks Using the Lugano Classification |
11.1 | — |
| SECONDARY Complete Response Rate During the Treatment Period Using the Revised Response Cheson Criteria |
16.7; 30.0; 11.1 | — |
| SECONDARY Cohort IIIa Only: Complete Response Rate During the Treatment Period Using the Lugano Classification |
11.1 | — |
| SECONDARY Progression Free Survival by the Revised Response Cheson Criteria |
4.2; 1.9; 2.8 | — |
| SECONDARY Cohort IIIa Only: Progression Free Survival Using the Lugano Classification |
4.8 | — |
| SECONDARY Overall Survival |
9.2; 7.0; NA | — |
| SECONDARY Duration of Response for Participants Who Achieved CR/PR Using the Revised Response Cheson Criteria |
NA; 27.0; 4.4 | — |
| SECONDARY Cohort IIIa Only: Duration of Response for Participants Who Achieved CMR/PMR Using the Lugano Classification |
8.0 | — |
| SECONDARY Blinatumomab Steady State Concentration (Css) |
280; 711; 1380; 2090 | — |
| SECONDARY Blinatumomab Clearance |
1.84; 2.06; 1.76 | — |
| SECONDARY Pembrolizumab Peak Serum Concentration |
52.7; 124 | — |
| SECONDARY Pembrolizumab Minimum Serum Concentration |
13.9; 34.2; 50.5; 62.6; 53.2 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
12; 10; 9; 12; 10; 9 | — |
Eligibility 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 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 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.
Data sourced from ClinicalTrials.gov (NCT03340766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.