CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Blinatumomab +1 moredrug
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03340766
NCT03340766Phase 1Completed
CompareCT.gov

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)

Amgen·interventional·Posted Nov 14, 2017·Updated Oct 17, 2024

In Brief

A Phase 1 clinical trial evaluating Blinatumomab and Pembrolizumab for Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL). Completed, enrolled 31 participants across 22 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
CountriesAustralia, France, Germany, Netherlands, Spain, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartMar 16, 2018
Primary CompletionNov 6, 2020
Study CompletionAug 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.6 years ago

Interventions

Blinatumomabdrug

Up to 2 cycles of blinatumomab may be given, where cycle 1 lasts 8 weeks, and cycle 2 lasts 28 days. The treatment is given as a continuous intravenous infusion.

Pembrolizumabdrug

One cycle of pembrolizumab is a 200 mg IV injection lasting 30 minutes. One cycle will be given every 3 weeks until disease progression, or for a maximum of 35 cycles.