MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)
A Phase 1b Study to Evaluate the Safety and Efficacy of MEDI4736 as Monotherapy and in Combination With Tremelimumab or AZD9150 in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma.
1 other identifier
interventional
32
4 countries
13
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736 (durvalumab) alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory dIffuse large B-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2016
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedStudy Start
First participant enrolled
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2019
CompletedFebruary 27, 2019
February 1, 2019
2.6 years
August 27, 2015
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
Screening through 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicities
Changes from baseline in laboratory parameters, vital signs, and ECGs
First dose of study medications through 28 days after the administration of MEDI4736 or MEDI4736 and tremelimumab, 35 days after administration of MEDI4736 and AZD9150
Secondary Outcomes (18)
Number of subjects who develop anti-drug antibodies (ADA)
Screening through 90 days after last dose of study medication
Time to Response
Screening though 3 years after the last subject receives the first dose of study medication
Duration of Response
Screening though 3 years after the last subject receives the first dose of study medication
Progression Free survival
Screening though 3 years after the last subject receives the first dose of study medication
Time to progression
Screening though 3 years after the last subject receives the first dose of study medication
- +13 more secondary outcomes
Study Arms (3)
MEDI4736
EXPERIMENTALMEDI4736 and tremelimumab
EXPERIMENTALMEDI4736 and AZD9150
EXPERIMENTALInterventions
MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Subjects with histologically confirmed relapsed or refractory DLBCL who have received at least 1 prior rituximab containing chemotherapy regimen but no more than 5 prior lines of therapy
- Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Measurable disease by International Working Group (IWG) response criteria for lymphoma
- Adequate organ and marrow function
You may not qualify if:
- Previous immune-mediated therapy
- Subjects with prior ASCT or allogenic HCT. Subjects ineligible for available curative options after failing ASCT and have met the hematologic criteria are eligible to participate in this study. Subjects with prior allogenic HCT will be excluded.
- Documented current central nervous system involvement
- \. Active or prior documented autoimmune or inflammatory disease within 3 years, with some exceptions 4. Concurrent or prior conventional or investigational anticancer therapy, within 28 days prior to the first dose of study medication(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (13)
Research Site
La Jolla, California, 92093, United States
Research Site
Baltimore, Maryland, 21201, United States
Research Site
Albuquerque, New Mexico, 87131, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Charleston, South Carolina, 29425, United States
Research Site
Dallas, Texas, 75390, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Research Site
Marseille, 13273, France
Research Site
Villejuif, 94805, France
Research Site
Dublin, Ireland
Research Site
Galway, Ireland
Research Site
Leicester, LE1 5WW, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MedImmune LLC
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 15, 2015
Study Start
July 13, 2016
Primary Completion
February 4, 2019
Study Completion
February 4, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02