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Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) (HARBOUR)

Primary Purpose

Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Blinatumomab

Pembrolizumab

About this trial

This is an interventional treatment trial for Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) focused on measuring DLBCL Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT), Antibodies, Bispecific in combination with PD-1/PD-L1 inhibitor

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort Ia: Blinatumomab 9/28 µg/day + Pembrolizumab

Cohort IIa: Blinatumomab 9/28/56 µg/day + Pembrolizumab

Cohort IIIa: Blinatumomab 9/28/112 µg/day + Pembrolizumab

Expansion Cohort

Arm Description

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.

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.

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.

This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study.

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLTs)

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.

Secondary Outcome Measures

Objective Response Rate During the First 12 Weeks Using Revised Response Criteria

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).

Objective Response Rate During the First 12 Weeks Using the Lugano Classification

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.

Objective Response Rate During the Treatment Period Using Revised Response Criteria

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).

Objective Response Rate During the Treatment Period Using the Lugano Classification

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.

Complete Response Rate During the First 12 Weeks Using the Revised Response Criteria

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.

Complete Response Rate During the First 12 Weeks Using the Lugano Classification

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.

Complete Response Rate During the Treatment Period Using the Revised Response Criteria

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.

Complete Response Rate During the Treatment Period Using the Lugano Classification

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.

Progression Free Survival by the Revised Response Criteria

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.

Progression Free Survival Using the Lugano Classification

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.

Overall Survival

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.

Duration of Response Response for Participants Who Achieved CR/PR Using the Revised Response Criteria

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.

Duration of Response for Participants Who Achieved CR/PR Using the Lugano Classification

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.

Blinatumomab Steady State Concentration

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.

Blinatumomab Clearance

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.

Pembrolizumab Peak Plasma Concentration

Pembrolizumab serum concentrations were quantified using a validated electro-chemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.

Pembrolizumab Minimum Plasma Concentration

Pembrolizumab serum concentrations were quantified using a validated electrochemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.

Full Information

NCT ID

NCT03340766

First Posted

October 23, 2017

Last Updated

August 15, 2023

Sponsor

Amgen

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03340766

Brief 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)

Acronym

HARBOUR

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 16, 2018 (Actual)

Primary Completion Date

November 6, 2020 (Actual)

Study Completion Date

August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The study was planned as 2 parts: Part 1 will test the safety of up to 3 different blinatumomab target dose levels in combination with pembrolizumab in a rolling 6 design. A Dose Level Review Team (DLRT) will review the safety data to evaluate possible drug effects and dose-limiting toxicities (DLTs). Part 2 will consist of an expansion cohort to assess pharmacokinetics (PK), safety, and preliminary efficacy data at the chosen target dose. The part 2 dose will be determined by the totality of the clinical data from part 1 as determined by the DLRT. Based on the results from Part 1, a decision was made not to proceed with Part 2 of this study. Secondary objectives of the study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of blinatumomab in combination with pembrolizumab. Tumor response will be evaluated according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al, 2007). With implementation of Protocol Amendment 5, response will also be assessed according to the Lugano Classification (Cheson et al, 2014). Only participants enrolled after implementation of Protocol Amendment 5 (03 December 2019) will have tumor assessments using the Lugano criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Keywords

DLBCL Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT), Antibodies, Bispecific in combination with PD-1/PD-L1 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort Ia: Blinatumomab 9/28 µg/day + Pembrolizumab

Arm Type

Experimental

Arm Description

Arm Title

Cohort IIa: Blinatumomab 9/28/56 µg/day + Pembrolizumab

Arm Type

Experimental

Arm Description

Arm Title

Cohort IIIa: Blinatumomab 9/28/112 µg/day + Pembrolizumab

Arm Type

Experimental

Arm Description

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.

Arm Title

Expansion Cohort

Arm Type

Experimental

Arm Description

This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study.

Intervention Type

Drug

Intervention Name(s)

Blinatumomab

Other Intervention Name(s)

Blincyto, AMG 103, Formerly known as MT103 or bscCD19xCD3

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

Keytruda, MK-3475

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLTs)

Description

Time Frame

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)

Secondary Outcome Measure Information:

Title

Objective Response Rate During the First 12 Weeks Using Revised Response Criteria

Description

Time Frame

First 12 weeks of of blinatumomab treatment

Title

Objective Response Rate During the First 12 Weeks Using the Lugano Classification

Description

Time Frame

First 12 weeks of of blinatumomab treatment

Title

Objective Response Rate During the Treatment Period Using Revised Response Criteria

Description

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).

Time Frame

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.

Title

Objective Response Rate During the Treatment Period Using the Lugano Classification

Description

Time Frame

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.

Title

Complete Response Rate During the First 12 Weeks Using the Revised Response Criteria

Description

Time Frame

First 12 weeks of of blinatumomab treatment

Title

Complete Response Rate During the First 12 Weeks Using the Lugano Classification

Description

Time Frame

First 12 weeks of of blinatumomab treatment

Title

Complete Response Rate During the Treatment Period Using the Revised Response Criteria

Description

Time Frame

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.

Title

Complete Response Rate During the Treatment Period Using the Lugano Classification

Description

Time Frame

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.

Title

Progression Free Survival by the Revised Response Criteria

Description

Time Frame

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.

Title

Progression Free Survival Using the Lugano Classification

Description

Time Frame

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.

Title

Overall Survival

Description

Time Frame

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.

Title

Duration of Response Response for Participants Who Achieved CR/PR Using the Revised Response Criteria

Description

Time Frame

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.

Title

Duration of Response for Participants Who Achieved CR/PR Using the Lugano Classification

Description

Time Frame

Up to the data cut-off date of 17 November 2020; Maximum time on follow-up for DOR was 1 month.

Title

Blinatumomab Steady State Concentration

Description

Time Frame

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).

Title

Blinatumomab Clearance

Description

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.

Time Frame

Title

Pembrolizumab Peak Plasma Concentration

Description

Pembrolizumab serum concentrations were quantified using a validated electro-chemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.

Time Frame

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.

Title

Pembrolizumab Minimum Plasma Concentration

Description

Pembrolizumab serum concentrations were quantified using a validated electrochemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92093-0960

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29424

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Research Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Research Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Research Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Research Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Research Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Research Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Research Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Research Site

City

Créteil Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Research Site

City

Nantes Cedex 1

ZIP/Postal Code

44035

Country

France

Facility Name

Research Site

City

Pierre-Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Research Site

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Research Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Research Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Research Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Research Site

City

Rotterdam

ZIP/Postal Code

3015 CN

Country

Netherlands

Facility Name

Research Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Research Site

City

Salamanca

State/Province

Castilla León

ZIP/Postal Code

37007

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing URL

https://www.amgen.com/datasharing

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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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Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) (HARBOUR)

Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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