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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002191-27 | EudraCT Number | ||
| PN348 | Other Identifier | Merck Protocol Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
The study was planned as 2 parts:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Ia: Blinatumomab 9/28 µg/day + Pembrolizumab | Experimental | 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. |
|
| Cohort IIa: Blinatumomab 9/28/56 µg/day + Pembrolizumab | Experimental | 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. |
|
| Cohort IIIa: Blinatumomab 9/28/112 µg/day + Pembrolizumab | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate During the First 12 Weeks Using Revised Response Cheson Criteria | Objective response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR):
Participants with no post-baseline response assessments were considered non-responders. |
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Inclusion Criteria:
Other Inclusion Criteria May Apply
Exclusion Criteria:
Other Exclusion Criteria May Apply.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | 92093-0960 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
Participants were enrolled into each dose cohort sequentially using a rolling 6 study design. A Dose Level Review Team (DLRT) reviewed the safety data to evaluate possible drug effects and dose-limiting toxicities (DLTs).
This study was conducted at 11 centers in Australia, France, Netherlands, Spain, and the United States.
The study was planned as 2 parts. Based on the results from Part 1, a decision was made not to proceed with Part 2 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort Ia: Blinatumomab 9/28 µg/Day + Pembrolizumab | Participants in Cohort Ia 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 21 days of treatment. Starting on study Day 15 participants also received 200 mg pembrolizumab administered by IV infusion every 3 weeks (Q3W) until disease progression or for up to 35 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2022 | Jun 6, 2024 |
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|
| Expansion Cohort | Experimental | This cohort will test the maximum tolerated dose of blinatumomab in combination with pembrolizumab identified in Part 1 of the study. |
|
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| Pembrolizumab | Drug | 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. |
|
|
| First 12 weeks of blinatumomab treatment |
| Cohort IIIa Only: 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 metabolic response (CMR) or a partial metabolic response (PMR):
Participants with no post-baseline response assessments were considered non-responders. | First 12 weeks of blinatumomab treatment |
| Objective Response Rate During the Treatment Period Using Revised Response Cheson Criteria | Objective response rate is defined as the percentage of participants with either a CR or a PR according to the Revised Response Criteria (2007):
Participants with no post-baseline response assessments were considered non-responders. | From Day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days. |
| Cohort IIIa Only: Objective Response Rate During the Treatment Period Using the Lugano Classification | Objective response rate is defined as the percentage of participants with either a CMR or a CMR.
Participants with no post-baseline response assessments were considered non-responders. | 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 During the First 12 Weeks Using the Revised Response Cheson Criteria | Complete response rate is defined as the percentage of participants with a CR according to the Revised Response Criteria (2007): - 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. Participants with no post-baseline response assessments were considered non-responders. | First 12 weeks of blinatumomab treatment |
| Cohort IIIa Only: Complete Response Rate During the First 12 Weeks Using the Lugano Classification | Complete response rate is defined as the percentage of participants with a CMR according to the Lugano classification (2014): CMR: For PET-CT-based response, score of 1-3 on the Deauville 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. Participants with no post-baseline response assessments were considered non-responders. | First 12 weeks of blinatumomab treatment |
| Complete Response Rate During the Treatment Period Using the Revised Response Cheson Criteria | Complete response rate is defined as the percentage of participants with a complete response according to the Revised Response Criteria (2007): - 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. Participants with no post-baseline response assessments were considered non-responders. | From Day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days. |
| Cohort IIIa Only: Complete Response Rate During the Treatment Period Using the Lugano Classification | Complete response rate is defined as the percentage of participants with a CMR according to the Lugano classification (2014): - CMR: For PET-CT-based response, score of 1-3 on the Deauville 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. Participants with no post-baseline response assessments were considered non-responders. | From Day 1 to 30 days after last dose of either blinatumomab or pembrolizumab administration; the overall median duration of treatment was 87 days. |
| Progression Free Survival by the Revised Response Cheson Criteria | 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 Cheson 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. | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
| Cohort IIIa Only: 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. | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
| Overall Survival | Overall survival 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. | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
| Duration of Response for Participants Who Achieved CR/PR Using the Revised Response Cheson Criteria | Duration of response 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. | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
| Cohort IIIa Only: Duration of Response for Participants Who Achieved CMR/PMR Using the Lugano Classification | The duration of response was calculated from the date a response of CMR or PMR 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. | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
| Blinatumomab Steady State Concentration (Css) | 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 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. | 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). |
| 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. | 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). |
| Pembrolizumab Peak Serum Concentration | Pembrolizumab serum concentrations were quantified using a validated electro-chemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL. The pembrolizumab pharmacokinetic data from all cohorts were combined for analysis. | Within approximately 30 minutes after the end of the infusion in cycle 1 (study day 15 for Cohort Ia, study day 19 for Cohorts IIa and IIIa) and cycle 8 (study day 162 for Cohort Ia and day 166 for Cohorts IIa and IIIa). |
| Pembrolizumab Minimum Serum Concentration | Pembrolizumab serum concentrations were quantified using a validated electrochemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL. The pembrolizumab pharmacokinetic data from all cohorts were combined for analysis. | Pre-dose on pembrolizumab cycles 2, 4, 6, 8, and 12 (Study days 36, 78, 120, 162, and 246, respectively). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as any untoward medical occurrence in a clinical trial participant that started after the initiation of blinatumomab. All TEAEs were graded using NCI CTCAE Version 4.0:
| From first dose of blinatumomab to minimum of 30 days after last dose of blinatumomab or pembrolizumab (whichever was later) or end of study: median (min, max) duration was 22.7 (1.0, 85.8) days. |
| Charleston |
| South Carolina |
| 29424 |
| United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | Darlinghurst | New South Wales | 2010 | Australia |
| Research Site | St Leonards | New South Wales | 2065 | Australia |
| Research Site | Adelaide | South Australia | 5000 | Australia |
| Research Site | East Melbourne | Victoria | 3002 | Australia |
| Research Site | Geelong | Victoria | 3220 | Australia |
| Research Site | Melbourne | Victoria | 3004 | Australia |
| Research Site | Murdoch | Western Australia | 6150 | Australia |
| Research Site | Créteil | 94010 | France |
| Research Site | Nantes | 44035 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Heidelberg | 69120 | Germany |
| Research Site | Ulm | 89081 | Germany |
| Research Site | Würzburg | 97080 | Germany |
| Research Site | Maastricht | 6229 HX | Netherlands |
| Research Site | Rotterdam | 3015 CN | Netherlands |
| Research Site | Santander | Cantabria | 39008 | Spain |
| Research Site | Salamanca | Castille and León | 37007 | Spain |
| Research Site | Barcelona | Catalonia | 08025 | Spain |
| Research Site | Madrid | 28046 | Spain |
| FG001 | Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab | Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| FG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| Received Blinatumomab |
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| Received Pembrolizumab |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set: Included all participants who received blinatumomab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort Ia: Blinatumomab 9/28 µg/Day + Pembrolizumab | Participants in Cohort Ia received blinatumomab administered as 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 21 days of treatment. Starting on study Day 15 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| BG001 | Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab | Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| BG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| DLT Analysis Set: Included participants who experienced a DLT, OR were removed from treatment for an adverse event/toxicity that was not a DLT or for other reasons and had been exposed to study treatment for ≥ 12 days OR completed the DLT evaluation period. | Posted | Count of Participants | Participants | 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 | Objective Response Rate During the First 12 Weeks Using Revised Response Cheson Criteria | Objective response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR):
Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | First 12 weeks of blinatumomab treatment |
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| Secondary | Cohort IIIa Only: 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 metabolic response (CMR) or a partial metabolic response (PMR):
Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | First 12 weeks of blinatumomab treatment |
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| Secondary | Objective Response Rate During the Treatment Period Using Revised Response Cheson Criteria | Objective response rate is defined as the percentage of participants with either a CR or a PR according to the Revised Response Criteria (2007):
Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | From 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 | Cohort IIIa Only: Objective Response Rate During the Treatment Period Using the Lugano Classification | Objective response rate is defined as the percentage of participants with either a CMR or a CMR.
Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 | Complete Response Rate During the First 12 Weeks Using the Revised Response Cheson Criteria | Complete response rate is defined as the percentage of participants with a CR according to the Revised Response Criteria (2007): - 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. Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | First 12 weeks of blinatumomab treatment |
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| Secondary | Cohort IIIa Only: Complete Response Rate During the First 12 Weeks Using the Lugano Classification | Complete response rate is defined as the percentage of participants with a CMR according to the Lugano classification (2014): CMR: For PET-CT-based response, score of 1-3 on the Deauville 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. Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | First 12 weeks of blinatumomab treatment |
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| Secondary | Complete Response Rate During the Treatment Period Using the Revised Response Cheson Criteria | Complete response rate is defined as the percentage of participants with a complete response according to the Revised Response Criteria (2007): - 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. Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | From 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 | Cohort IIIa Only: Complete Response Rate During the Treatment Period Using the Lugano Classification | Complete response rate is defined as the percentage of participants with a CMR according to the Lugano classification (2014): - CMR: For PET-CT-based response, score of 1-3 on the Deauville 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. Participants with no post-baseline response assessments were considered non-responders. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Number | 95% Confidence Interval | percentage of participants | From 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 | Progression Free Survival by the Revised Response Cheson Criteria | 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 Cheson 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. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Median | 95% Confidence Interval | months | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
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| Secondary | Cohort IIIa Only: 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. | Full Analysis Set: Included all participants who received blinatumomab with available post-baseline response per the Lugano classification. | Posted | Median | 95% Confidence Interval | months | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
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| Secondary | Overall Survival | Overall survival 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. | Full Analysis Set: Included all participants who received blinatumomab. | Posted | Median | 95% Confidence Interval | months | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
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| Secondary | Duration of Response for Participants Who Achieved CR/PR Using the Revised Response Cheson Criteria | Duration of response 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. | Full Analysis Set: Included all participants with a CR or PR during the first 12 weeks of blinatumomab treatment according to the revised response criteria were included. | Posted | Median | 95% Confidence Interval | months | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
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| Secondary | Cohort IIIa Only: Duration of Response for Participants Who Achieved CMR/PMR Using the Lugano Classification | The duration of response was calculated from the date a response of CMR or PMR 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. | Full Analysis Set: Included all participants with a CMR or PMR during the first 12 weeks of blinatumomab treatment according to the Lugano classification. | Posted | Median | 95% Confidence Interval | months | From first dose of blinatumomab up to the end of study. Median (min, max) time on study was 188.0 days (19.0, 1512.0). |
|
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| Secondary | Blinatumomab Steady State Concentration (Css) | 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 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. | Pharmacokinetic Analysis Set: Included all participants who received any infusion of blinatumomab or pembrolizumab and had at least 1 pharmacokinetic sample collected. | Posted | Mean | Standard Deviation | pg/mL | 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 | 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. | Pharmacokinetic Analysis Set: Included all participants who received any infusion of blinatumomab or pembrolizumab and had at least 1 pharmacokinetic sample collected. | Posted | Mean | Standard Deviation | liters/hour | 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 | Pembrolizumab Peak Serum Concentration | Pembrolizumab serum concentrations were quantified using a validated electro-chemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL. The pembrolizumab pharmacokinetic data from all cohorts were combined for analysis. | Pharmacokinetic Analysis Set: Included all participants who received any infusion of blinatumomab or pembrolizumab and had at least 1 pharmacokinetic sample collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Within approximately 30 minutes after the end of the infusion in cycle 1 (study day 15 for Cohort Ia, study day 19 for Cohorts IIa and IIIa) and cycle 8 (study day 162 for Cohort Ia and day 166 for Cohorts IIa and IIIa). |
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| Secondary | Pembrolizumab Minimum Serum Concentration | Pembrolizumab serum concentrations were quantified using a validated electrochemiluminescent-based immunoassay with a lower limit of quantification of 25 ng/mL. The pembrolizumab pharmacokinetic data from all cohorts were combined for analysis. | Pharmacokinetic Analysis Set: Included all participants who received any infusion of blinatumomab or pembrolizumab and had at least 1 pharmacokinetic sample collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Pre-dose on pembrolizumab cycles 2, 4, 6, 8, and 12 (Study days 36, 78, 120, 162, and 246, respectively). |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as any untoward medical occurrence in a clinical trial participant that started after the initiation of blinatumomab. All TEAEs were graded using NCI CTCAE Version 4.0:
| Safety Analysis Set: Included all participants who received blinatumomab. | Posted | Count of Participants | Participants | From first dose of blinatumomab to minimum of 30 days after last dose of blinatumomab or pembrolizumab (whichever was later) or end of study: median (min, max) duration was 22.7 (1.0, 85.8) days. |
|
Mortality- From enrollment to end of study: median (min, max) was 188.0 (19.0 ,1512.0) days. TEAEs - From first dose of blinatumomab to minimum of 30 days after last dose blinatumomab/pembrolizumab: median (min, max) was 22.7 (1.0, 85.8) days.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort Ia: Blinatumomab 9/28 µg/Day + Pembrolizumab | Participants in Cohort Ia received blinatumomab administered as a 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 IV infusion Q3W until disease progression or for up to 35 cycles. | 6 | 12 | 9 | 12 | 12 | 12 |
| EG001 | Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab | Participants in Cohort IIa 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. | 7 | 10 | 7 | 10 | 10 | 10 |
| EG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa 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. | 4 | 9 | 9 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vestibular ataxia | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bacillus bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcus test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Apraxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucinations, mixed | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malignant ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ear swelling | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eye allergy | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Periorbital swelling | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal erythema | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tongue spasm | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Balanitis candida | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Enterococcus test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Helicobacter test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypouricaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Horner's syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ureteric compression | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Ureteral stent insertion | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spontaneous bacterial peritonitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Candida test positive | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Based on the results of Part 1, a decision was made not to proceed with Part 2 of this study.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2021 | Jun 6, 2024 | SAP_003.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510808 | blinatumomab |
| C568788 | N,N-dicyclohexyl-isoborneol-10-sulfonamide |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| From 65-84 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
|
| OG001 | Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab | Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
|
|
| OG001 | Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab | Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
|
|
| Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab |
Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
| Participants |
|
|
| OG001 | Cohort IIa: Blinatumomab 9/28/56 µg/Day + Pembrolizumab | Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants in Cohort IIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
|
|
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
| Participants |
|
|
Participants received blinatumomab administered via a continuous intravenous infusion of 56 µg/day. |
| OG003 | Blinatumomab 112 µg/Day | Participants received blinatumomab administered via a continuous intravenous infusion of 112 µg/day. |
|
|
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| OG002 | Cohort IIIa: Blinatumomab 9/28/112 µg/Day + Pembrolizumab | Participants in Cohort IIIa received blinatumomab administered as a CIVI for 8 weeks followed by a 28-day treatment-free interval. Participants with stable disease or better may have received an additional 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 21 days of treatment. Starting on study Day 19 participants also received 200 mg pembrolizumab administered by IV infusion Q3W until disease progression or for up to 35 cycles. |
|
|