MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C00023)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-13

Study Completion Date

2019-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

NCT02499328

Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck

COMPLETED PHASE1/PHASE2

Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies

NCT00275431

Follicular Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma +2 more

COMPLETED PHASE2

A Phase 1 Study of ADI-001 in B Cell Malignancies

NCT04735471

Lymphoma, Follicular Lymphoma, Mantle-Cell Marginal Zone Lymphoma +3 more

TERMINATED PHASE1

Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

NCT03011814

Folliculotropic Mycosis Fungoides Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides +5 more

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

AMG 319 Lymphoid Malignancy FIH

NCT01300026

Cancer Chronic Lymphocytic Leukemia Diffuse Large Cell Lymphoma +11 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B-Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion

Intervention Type DRUG

tremelimumab

Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion

Intervention Type DRUG

AZD9150

AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years
2. 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
3. Eastern Cooperative Group (ECOG) performance status of 0 or 1
4. Measurable disease by International Working Group (IWG) response criteria for lymphoma
5. Adequate organ and marrow function

Exclusion Criteria

1. Previous immune-mediated therapy
2. 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.
3. Documented current central nervous system involvement

3\. 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No