MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Participants With Relapsed/Refractory DLBCL (D4190C00023)
Study identifier:D4190C00023
ClinicalTrials.gov identifier:NCT02549651
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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.
Medical condition
Diffuse Large B-Cell Lymphoma
Phase
Phase 1
Healthy volunteers
No
Study drug
Durvalumab, tremelimumab, AZD9150
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 13 Jul 2016
Primary Completion Date: 04 Feb 2019
Study Completion Date: 04 Feb 2019
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Durvalumab 20 mg/kg + Tremelimumab 1 mg/kg (Escalation) Participants will receive intravenous (IV) infusion of durvalumab 20 mg/kg in combination with tremelimumab 1 mg/kg every 4 weeks (Q4W) for 4 months (up to 4 doses; Day 1 of each 28-day treatment cycle); thereafter durvalumab monotherapy at 20 mg/kg Q4W until disease progression or another treatment discontinuation criterion is met. | Drug: Durvalumab Durvalumab is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion Other Name: MEDI4736 Drug: tremelimumab Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion |
| Experimental: Durvalumab 20 mg/kg + AZD9150 2 mg/kg (Escalation) Participants will receive IV infusion of durvalumab 20 mg/kg Q4W (Day 8 of each 28-day treatment cycle) in combination with AZD9150 2 mg/kg (Days 1, 3, 5, 8, 15, and 22 in Cycle 1 and on Days 1, 8, 15, and 22 from subsequent cycle; each cycle was of 28-day) until disease progression or another treatment discontinuation criterion is met. | Drug: Durvalumab Durvalumab is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion Other Name: MEDI4736 Drug: AZD9150 AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion |
| Experimental: Durvalumab 20 mg/kg + AZD9150 3 mg/kg (Escalation) Participants will receive IV infusion of durvalumab 20 mg/kg Q4W (Day 8 of each 28-day treatment cycle) in combination with AZD9150 3 mg/kg (Days 1, 3, 5, 8, 15, and 22 in Cycle 1 and on Days 1, 8, 15, and 22 from subsequent cycle; each cycle was of 28-day) until disease progression or another treatment discontinuation criterion is met. | Drug: Durvalumab Durvalumab is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion Other Name: MEDI4736 Drug: AZD9150 AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion |
| Experimental: Durvalumab 20 mg/kg + AZD9150 3 mg/kg (Expansion) Participants will receive IV infusion of durvalumab 20 mg/kg Q4W (Day 8 of each 28-day treatment cycle) in combination with AZD9150 3 mg/kg (Days 1, 3, 5, 8, 15, and 22 in Cycle 1 and on Days 1, 8, 15, and 22 from subsequent cycle; each cycle was of 28-day) until disease progression or another treatment discontinuation criterion is met. | Drug: Durvalumab Durvalumab is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion Other Name: MEDI4736 Drug: AZD9150 AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune LLC
