NCT02549651

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	MEDI4736	MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
DRUG	tremelimumab	Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
DRUG	AZD9150	AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

Timeline

• Start date: 2016-07-13
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2015-09-15
• Last updated: 2019-02-27

Locations

13 sites across 4 countries: United States, France, Ireland, United Kingdom

Regulatory

• FDA-regulated drug study