A Phase 1 interventional study of MEDI4736 and tremelimumab in Diffuse Large B-Cell Lymphoma, sponsored by MedImmune LLC. Completed at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by MedImmune LLC · Phase 1, Interventional, and Treatment
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.
This is a multicenter, open-label, dose-escalation and dose-expansion study of MEDI4736 (durvalumab) as monotherapy or in combination with either tremelimumab or AZD9150. The objectives are to describe any dose-limiting toxicities, determine the maximum tolerated dose, and evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of MEDI4736 as monotherapy or in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: MEDI4736
Drug: MEDI4736 · Drug: tremelimumab
Drug: MEDI4736 · Drug: AZD9150
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
Number of subjects reporting adverse events and number (percentage) of subjects reporting serious adverse events
Time frame: 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
Time frame: 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
Number of subjects who develop anti-drug antibodies (ADA)
Time frame: Screening through 90 days after last dose of study medication
Time to Response
Time frame: Screening though 3 years after the last subject receives the first dose of study medication
Duration of Response
Time frame: Screening though 3 years after the last subject receives the first dose of study medication
Progression Free survival
Time frame: Screening though 3 years after the last subject receives the first dose of study medication
Time to progression
Time frame: Screening though 3 years after the last subject receives the first dose of study medication
Event free survival
Time frame: Screening though 3 years after the last subject receives the first dose of study medication
Overall survival
Time frame: Screening though 3 years after the last subject receives the first dose of study medication
MEDI4736 Maximum Plasma Concentration (Cmax)
Time frame: Measured at defined study visits from time of first dose through end of treatment
Tremelimumab Maximum Plasma Concentration (Cmax)
Time frame: Measured at defined study visits from time of first dose through end of treatment
AZD9150 Maximum Plasma Concentration (Cmax)
Time frame: Measured at defined study visits from time of first dose through end of treatment
MEDI4736 Minimum Plasma Concentration (Cmin)
Time frame: Measured at defined study visits from time of first dose through end of treatment
Tremelimumab Minimum Plasma Concentration (Cmin)
Time frame: Measured at defined study visits from time of first dose through end of treatment
AZD9150 Minimum Plasma Concentration (Cmin)
Time frame: Measured at defined study visits from time of first dose through end of treatment
Individual MEDI4736 Concentrations
Time frame: Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Individual tremelimumab Concentrations
Time frame: Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Individual AZD9150 Concentrations
Time frame: Measured at defined study visits from time of first dose through 90 days after the end of treatment (approximately 15 months)
Change from baseline of STAT3 RNA (signal transducer and activator of transcription)
Time frame: Measured at defined study visits from time of first dose through 90 days after last dose (approximately 15 months)
Baseline PD-L1 protein expression within the tumor
Time frame: Measured on tumor samples provided at screening
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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