We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340766
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Results First Posted : February 25, 2022
Last Update Posted : February 25, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) Drug: Blinatumomab Drug: Pembrolizumab Phase 1

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : November 17, 2020
Estimated Study Completion Date : August 14, 2023


Arm Intervention/treatment
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.

Drug: 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.
Other Names:
  • Blincyto
  • AMG 103
  • Formerly known as MT103 or bscCD19xCD3

Drug: 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.
Other Names:
  • Keytruda
  • MK-3475

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.

Drug: 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.
Other Names:
  • Blincyto
  • AMG 103
  • Formerly known as MT103 or bscCD19xCD3

Drug: 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.
Other Names:
  • Keytruda
  • MK-3475

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.

Drug: 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.
Other Names:
  • Blincyto
  • AMG 103
  • Formerly known as MT103 or bscCD19xCD3

Drug: 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.
Other Names:
  • Keytruda
  • MK-3475

Experimental: Expansion Cohort
This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study.
Drug: 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.
Other Names:
  • Blincyto
  • AMG 103
  • Formerly known as MT103 or bscCD19xCD3

Drug: 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.
Other Names:
  • Keytruda
  • MK-3475




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities (DLTs) [ 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) ]

    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 :
  1. Objective Response Rate During the First 12 Weeks Using Revised Response Criteria [ Time Frame: First 12 weeks of of blinatumomab treatment ]

    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).


  2. Objective Response Rate During the First 12 Weeks Using the Lugano Classification [ Time Frame: First 12 weeks of of blinatumomab treatment ]

    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.


  3. Objective Response Rate During the Treatment Period Using Revised Response Criteria [ 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. ]

    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).


  4. Objective Response Rate During the Treatment Period Using the Lugano Classification [ 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. ]

    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.


  5. Complete Response Rate During the First 12 Weeks Using the Revised Response Criteria [ Time Frame: First 12 weeks of of blinatumomab treatment ]

    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.


  6. Complete Response Rate During the First 12 Weeks Using the Lugano Classification [ Time Frame: First 12 weeks of of blinatumomab treatment ]

    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.


  7. Complete Response Rate During the Treatment Period Using the Revised Response Criteria [ 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. ]

    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.


  8. Complete Response Rate During the Treatment Period Using the Lugano Classification [ 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. ]

    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.


  9. Progression Free Survival by the Revised Response Criteria [ 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. ]

    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.


  10. Progression Free Survival Using the Lugano Classification [ 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. ]

    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.


  11. Overall Survival [ 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. ]
    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.

  12. Duration of Response Response for Participants Who Achieved CR/PR Using the Revised Response Criteria [ 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. ]
    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.

  13. Duration of Response for Participants Who Achieved CR/PR Using the Lugano Classification [ Time Frame: Up to the data cut-off date of 17 November 2020; Maximum time on follow-up for DOR was 1 month. ]

    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.


  14. Blinatumomab Steady State Concentration [ 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). ]

    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.


  15. Blinatumomab Clearance [ 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). ]
    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.

  16. Pembrolizumab Peak Plasma Concentration [ 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. ]
    Pembrolizumab serum concentrations were quantified using a validated electro-chemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.

  17. Pembrolizumab Minimum Plasma Concentration [ 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) ]
    Pembrolizumab serum concentrations were quantified using a validated electrochemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340766


Locations
Layout table for location information
United States, California
Research Site
La Jolla, California, United States, 92093-0960
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29424
Research Site
Greenville, South Carolina, United States, 29607
Australia, New South Wales
Research Site
Darlinghurst, New South Wales, Australia, 2010
Research Site
St Leonards, New South Wales, Australia, 2065
Australia, South Australia
Research Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Research Site
East Melbourne, Victoria, Australia, 3002
Research Site
Geelong, Victoria, Australia, 3220
Research Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Research Site
Murdoch, Western Australia, Australia, 6150
France
Research Site
Créteil Cedex, France, 94010
Research Site
Nantes Cedex 1, France, 44035
Research Site
Pierre-Benite, France, 69495
Germany
Research Site
Heidelberg, Germany, 69120
Research Site
Ulm, Germany, 89081
Research Site
Würzburg, Germany, 97080
Netherlands
Research Site
Maastricht, Netherlands, 6229 HX
Research Site
Rotterdam, Netherlands, 3015 CN
Spain
Research Site
Santander, Cantabria, Spain, 39008
Research Site
Salamanca, Castilla León, Spain, 37007
Research Site
Barcelona, Cataluña, Spain, 08025
Research Site
Madrid, Spain, 28046
Sponsors and Collaborators
Amgen
Merck Sharp & Dohme LLC
Investigators
Layout table for investigator information
Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] December 3, 2019
Statistical Analysis Plan  [PDF] October 2, 2017

Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03340766    
Other Study ID Numbers: 20150290
2016-002191-27 ( EudraCT Number )
PN348 ( Other Identifier: Merck Protocol Number )
First Posted: November 14, 2017    Key Record Dates
Results First Posted: February 25, 2022
Last Update Posted: February 25, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
DLBCL Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
Antibodies
Bispecific in combination with PD-1/PD-L1 inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Pembrolizumab
Blinatumomab
Antineoplastic Agents, Immunological
Antineoplastic Agents