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Recruitment Complete
Sponsor ID
20150290

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

Sponsor ID
20150290
Clinicaltrials.gov ID
NCT03340766
EUCTIS ID
N/A
EudraCT ID
2016-002191-27
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
31
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: The DLT evaluation period was 42 days from initiation of pembrolizumab treatment (day 15 for Cohort Ia and day 19 for Cohorts IIa and IIIa)

Secondary Outcome Measures

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

Timeframe: First 12 weeks of of blinatumomab treatment

Objective Response Rate During the first 12 Weeks using the Lugano Classification

Timeframe: First 12 weeks of of blinatumomab treatment

Objective Response Rate During the Treatment Period Using Revised Response Cheson Criteria

Timeframe: 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 During the Treatment Period Using the Lugano Classification

Timeframe: 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

Timeframe: First 12 weeks of of blinatumomab treatment

Complete Response Rate During the first 12 Weeks using the Lugano Classification

Timeframe: First 12 weeks of of blinatumomab treatment

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

Timeframe: 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 Treatment Period Using the Lugano Classification

Timeframe: 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.

Progression Free Survival by the Revised Response Criteria

Timeframe: 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 Using the Lugano Classification

Timeframe: 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.

Overall Survival

Timeframe: 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.

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

Timeframe: 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 for Participants Who Achieved CR/PR Using the Lugano Classification

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

Blinatumomab Steady State Concentration

Timeframe: 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

Timeframe: 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 Plasma Concentration

Timeframe: 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 Minimum Plasma Concentration

Timeframe: Pre-dose on pembrolizumab cycles 2, 4, 6, 8, and 12 (Study days 36, 78, 120, 162, and 246, respectively).

Locations

Location
Status
Contact Us
Location
Research Site
Darlinghurst, NSW, Australia, 2010
Status
Recruiting
Location
Research Site
Murdoch, WA, Australia, 6150
Status
Recruiting
Location
Research Site
Melbourne, VIC, Australia, 3004
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Charleston, SC, United States, 29424
Status
Completed
Location
Research Site
Geelong, VIC, Australia, 3220
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Lymphoma
    • Sex
    All
    Trial Dates
    Mar 2018 - Nov 2020
    Inclusion and Exclusion 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.