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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03340766
Registration number
NCT03340766
Ethics application status
Date submitted
23/10/2017
Date registered
14/11/2017
Date last updated
11/09/2023
Titles & IDs
Public title
Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
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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)
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Secondary ID [1]
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2016-002191-27
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Secondary ID [2]
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20150290
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Universal Trial Number (UTN)
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Trial acronym
HARBOUR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Blinatumomab
Treatment: Drugs - Pembrolizumab
Experimental: Cohort Ia: Blinatumomab 9/28 µg/day + Pembrolizumab - Participants received blinatumomab administered as a continuous intravenous infusion (CIVI) for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days then 28 µg/day for the remaining days of treatment.
Starting on Day 15 participants also received 200 mg pembrolizumab administered by intravenous (IV) infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles.
Experimental: Cohort IIa: Blinatumomab 9/28/56 µg/day + Pembrolizumab - Participants received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 56 µg/day for the remaining days of treatment.
Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
Experimental: Cohort IIIa: Blinatumomab 9/28/112 µg/day + Pembrolizumab - Participants received blinatumomab administered as a continuous intravenous infusion for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received a second 28-day consolidation cycle. The starting dose of each cycle was 9 µg/day for the first 7 days, 28 µg/day for 7 days then 112 µg/day for the remaining days of treatment.
Starting on Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles.
Experimental: Expansion Cohort - This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study.
Treatment: Drugs: Blinatumomab
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.
Treatment: Drugs: Pembrolizumab
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Dose-limiting toxicities were grade 3-5 adverse events that occurred during the DLT-evaluation period that were judged by the Investigator to be possibly, probably or definitely related to study drug administration.
All toxicities were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
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Timepoint [1]
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The DLT evaluation period was 42 days from initiation of pembrolizumab treatment (day 15 for Cohort Ia and day 19 for Cohorts IIa and IIIa)
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Secondary outcome [1]
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Objective Response Rate During the First 12 Weeks Using Revised Response Criteria
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Assessment method [1]
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Objective response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) according to the Revised Response Criteria (2007) during the first 12 weeks of blinatumomab treatment.
CR: Disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy: If fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET) positive before therapy, a residual mass of any size is permitted if it is PET negative; For variably FDG-avid or if a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size. Spleen or liver should not be palpable and normal size. Bone marrow infiltrate must have cleared or be negative by immunohistochemistry.
PR: Regression of measurable disease and no new sites (= 50% decrease in size of up to six of the largest dominant nodes or nodal masses and splenic and hepatic nodules).
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Timepoint [1]
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First 12 weeks of of blinatumomab treatment
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Secondary outcome [2]
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Objective Response Rate During the First 12 Weeks Using the Lugano Classification
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Assessment method [2]
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Objective response rate is defined as the percentage of participants with either a complete response or a partial response according to the Lugano classification (2014) during the first 12 weeks of blinatumomab treatment.
CR: For PET-computed tomography (CT)-based response, score of 1-3 on the Deauville five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of FDG-avid disease in marrow. For CT-based response, target nodes/masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology
PR: For PET-CT-based response, score of 4 or 5 on 5PS with reduced uptake compared to baseline for lymph nodes and extralymphatic sites, residual uptake reduced compared to baseline in the bone marrow. For CT-based response, = 50% decrease in sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites, spleen must have regressed by > 50% in length beyond normal.
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Timepoint [2]
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First 12 weeks of of blinatumomab treatment
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Secondary outcome [3]
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Objective Response Rate During the Treatment Period Using Revised Response Criteria
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Assessment method [3]
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Objective response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) according to the Revised Response Criteria (2007) during the treatment period.
CR: Disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy: If FDG-avid or PET positive before therapy, a residual mass of any size is permitted if it is PET negative; For variably FDG-avid or if a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. Spleen or liver should not be palpable and normal size. Bone marrow infiltrate must have cleared or be negative by immunohistochemistry.
PR: Regression of measurable disease and no new sites (= 50% decrease in size of up to six of the largest dominant nodes or nodal masses and splenic and hepatic nodules).
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Timepoint [3]
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From study day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days.
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Secondary outcome [4]
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Objective Response Rate During the Treatment Period Using the Lugano Classification
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Assessment method [4]
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Objective response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) according to the Lugano classification (2014).
CR: For PET-CT-based response, score of 1-3 on the Deauville five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of FDG-avid disease in marrow. For CT-based response, target nodes/masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology
PR: For PET-CT-based response, score of 4 or 5 on 5PS with reduced uptake compared to baseline for lymph nodes and extralymphatic sites, residual uptake reduced compared to baseline in the bone marrow. For CT-based response, = 50% decrease in sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites, spleen must have regressed by > 50% in length beyond normal.
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Timepoint [4]
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From study day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days.
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Secondary outcome [5]
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Complete Response Rate During the First 12 Weeks Using the Revised Response Criteria
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Assessment method [5]
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Complete response rate is defined as the percentage of participants with a complete response (CR) according to the Revised Response Criteria (2007) during the first 12 weeks of blinatumomab treatment.
CR: Disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy: If fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET) positive before therapy, a residual mass of any size is permitted if it is PET negative; For variably FDG-avid or if a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size. Spleen or liver should not be palpable and normal size. Bone marrow infiltrate must have cleared or be negative by immunohistochemistry.
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Timepoint [5]
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First 12 weeks of of blinatumomab treatment
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Secondary outcome [6]
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Complete Response Rate During the First 12 Weeks Using the Lugano Classification
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Assessment method [6]
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Complete response rate is defined as the percentage of participants with a complete response according to the Lugano classification (2014) during the first 12 weeks of blinatumomab treatment.
CR: For PET-computed tomography (CT)-based response, score of 1-3 on the Deauville five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of FDG-avid disease in marrow. For CT-based response, target nodes/masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology.
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Timepoint [6]
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First 12 weeks of of blinatumomab treatment
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Secondary outcome [7]
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Complete Response Rate During the Treatment Period Using the Revised Response Criteria
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Assessment method [7]
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Complete response rate is defined as the percentage of participants with a complete response according to the Revised Response Criteria (2007) during the treatment period.
CR: Disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy: If FDG-avid or PET positive before therapy, a residual mass of any size is permitted if it is PET negative; For variably FDG-avid or if a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. Spleen or liver should not be palpable and normal size. Bone marrow infiltrate must have cleared or be negative by immunohistochemistry.
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Timepoint [7]
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From study day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days.
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Secondary outcome [8]
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Complete Response Rate During the Treatment Period Using the Lugano Classification
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Assessment method [8]
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Complete response rate is defined as the percentage of participants with a complete response according to the Lugano classification (2014).
CR: For PET-CT-based response, score of 1-3 on the Deauville five-point scale (5PS) for lymph nodes and extralymphatic sites, no evidence of FDG-avid disease in marrow. For CT-based response, target nodes/masses regress to 1.5 cm in longest transverse diameter, no extralymphatic sites of disease, normal bone marrow morphology.
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Timepoint [8]
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From study day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days.
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Secondary outcome [9]
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Progression Free Survival by the Revised Response Criteria
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Assessment method [9]
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Progression-free survival (PFS) was calculated as the time from the date of the first dose of blinatumomab until the date of diagnosis of progression of lymphoma using the Revised Response Criteria (2007), or date of death, whichever was earliest. Participants who were alive and did not have progression were censored at the last radiological non-missing evaluable tumor assessment date.
Progressive disease per the revised response criteria is any new lesion or increase of 50% or greater in size of nodal masses or lesions or new or recurrent nodal involvement.
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Timepoint [9]
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From first dose of blinatumomab up to the data cut-off date of 17 November 2020; maximum time on follow-up for PFS was 24.4, 16.4, and 6.7 months in each cohort, respectively.
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Secondary outcome [10]
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Progression Free Survival Using the Lugano Classification
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Assessment method [10]
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Progression-free survival was calculated as the time from the date of the first dose of blinatumomab until the date of diagnosis of progression of lymphoma using the Lugano 2014 classification, or date of death, whichever was earliest. For diagnosis of progression of lymphoma, the progression of radiographic assessment of PET-CT using the Lugano Classification was used. Participants who were alive and did not have progression were censored at the last radiological non-missing evaluable tumor assessment date.
Progressive disease per the Lugano criteria is a score of 4 or 5 on the 5PS with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma.
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Timepoint [10]
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From first dose of blinatumomab up to the data cut-off date of 17 November 2020; maximum time on follow-up was 3.3 months.
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Secondary outcome [11]
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Overall Survival
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Assessment method [11]
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Overall survival (OS) was calculated as the time from the date of first dose of blinatumomab until death due to any cause. Participants who were alive at the analysis date were censored at the date last known to be alive.
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Timepoint [11]
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From first dose of blinatumomab up to the data cut-off date of 17 November 2020; maximum time on follow-up for OS was 29.7, 16.4, and 6.7 months in each cohort respectively.
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Secondary outcome [12]
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Duration of Response Response for Participants Who Achieved CR/PR Using the Revised Response Criteria
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Assessment method [12]
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Duration of response (DOR) was calculated from the date a response of CR or PR was first achieved until the earliest date of a disease assessment indicating a disease progression or death, whichever occurred first. Participants who did not have a relapse event were censored on their last radiological non-missing evaluable tumor assessment date.
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Timepoint [12]
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Up to the data cut-off date of 17 November 2020; Maximum time on follow-up for DOR was 22.3, 14.2, and 4.3 months in each cohort, respectively.
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Secondary outcome [13]
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Duration of Response for Participants Who Achieved CR/PR Using the Lugano Classification
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Assessment method [13]
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The duration of response (DOR) was calculated from the date a response of CR or PR was first achieved until the earliest date of a disease assessment indicating a disease progression using the Lugano classification or death, whichever occurred first.
Participants who did not have a relapse event were censored on their last radiological non-missing evaluable tumor assessment date.
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Timepoint [13]
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Up to the data cut-off date of 17 November 2020; Maximum time on follow-up for DOR was 1 month.
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Secondary outcome [14]
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Blinatumomab Steady State Concentration
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Assessment method [14]
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Serum blinatumomab concentrations were quantified using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) for the assay is 50 pg/mL.
The steady-state concentration (Css) of serum blinatumomab was summarized as the average of the observed concentrations collected after 24 hours from the start of continuous IV infusion or start of the dose step.
For calculation of Css at 9 µg/day and 28 µg/day dosing, participants in all cohorts were combined.
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Timepoint [14]
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Day 2 for 9 µg/day Css (all cohorts), days 10, 15, 22, 29, and 43 for 28 µg/day Css (Cohort Ia), day 10 for 28 µg/day Css (Cohorts IIa and IIIa), and days 19, 26, and 40 for 56 µg/day and 112 µg/day Css (Cohorts IIa and IIIa respectively).
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Secondary outcome [15]
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Blinatumomab Clearance
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Assessment method [15]
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Systemic clearance (CL) was calculated as CL=R0/Css,DN; where R0 is the infusion rate (µg/hr) and Css,DN is the dose normalized average Css.
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Timepoint [15]
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Day 2 for 9 µg/day Css (all cohorts), days 10, 15, 22, 29, and 43 for 28 µg/day Css (Cohort Ia), day 10 for 28 µg/day Css (Cohorts IIa and IIIa), and days 19, 26, and 40 for 56 µg/day and 112 µg/day Css (Cohorts IIa and IIIa respectively).
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Secondary outcome [16]
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Pembrolizumab Peak Plasma Concentration
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Assessment method [16]
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Pembrolizumab serum concentrations were quantified using a validated electro-chemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.
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Timepoint [16]
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Pembrolizumab cycle 1 day 1 (study day 15 for Cohort Ia, study day 19 for Cohorts IIa and IIIa) and cycle 8 day 1 (study day 162 for Cohort Ia and day 166 for Cohorts IIa and IIIa) within approximately 30 minutes after the end of the infusion.
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Secondary outcome [17]
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Pembrolizumab Minimum Plasma Concentration
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Assessment method [17]
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Pembrolizumab serum concentrations were quantified using a validated electrochemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.
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Timepoint [17]
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Pre-dose on pembrolizumab cycles 2, 4, 6, 8, and 12 (Study days 36, 78, 120, 162, and 246, respectively for Cohort Ia and study days 40, 82, 124, 166, and 250, respectively, for Cohorts IIa and IIIa)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/08/2023
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Darlinghurst
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Recruitment hospital [2]
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Research Site - St Leonards
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Recruitment hospital [3]
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Research Site - Adelaide
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Recruitment hospital [4]
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Research Site - East Melbourne
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Recruitment hospital [5]
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Research Site - Geelong
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Recruitment hospital [6]
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Research Site - Melbourne
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Recruitment hospital [7]
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Research Site - Murdoch
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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3004 - Melbourne
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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South Carolina
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Country [3]
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France
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State/province [3]
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Créteil Cedex
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Country [4]
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France
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State/province [4]
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Nantes Cedex 1
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Country [5]
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France
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State/province [5]
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Pierre-Benite
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Country [6]
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Germany
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State/province [6]
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Heidelberg
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Country [7]
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Germany
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State/province [7]
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Ulm
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Country [8]
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Germany
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State/province [8]
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Würzburg
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Country [9]
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Netherlands
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State/province [9]
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Maastricht
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Country [10]
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Netherlands
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State/province [10]
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Rotterdam
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Country [11]
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Spain
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State/province [11]
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Cantabria
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Country [12]
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Spain
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State/province [12]
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Castilla León
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Country [13]
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Spain
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State/province [13]
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Cataluña
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Country [14]
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Spain
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State/province [14]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03340766
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03340766
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