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Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome

NCT ID: NCT02117219

Last Updated: 2019-05-10

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-20

Study Completion Date

2019-04-30

Brief Summary

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This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents

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Detailed Description

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A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 \[PD-L1\]) to evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI4736 as monotherapy or in combination with Tremelimumab with or without Azacitidine in adult patients with myelodysplastic syndrome.

Conditions

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Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEDI4736 Evaluate MEDI4736 in MDS

Evaluate MEDI4736 monotherapy and MEDI4736 in combination with azacitidine after monotherapy progression in MDS

Group Type EXPERIMENTAL

MEDI4736 Evaluate MEDI4736 in MDS

Intervention Type BIOLOGICAL

MEDI4736 will be administered by IV infusion

VIDAZA

Intervention Type DRUG

VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy

MEDI4736 + tremelimumab

Evaluate MEDI4736 in combination with tremelimumab

Group Type EXPERIMENTAL

tremelimumab

Intervention Type BIOLOGICAL

tremelimumab will be administered by IV infusion

MEDI4736 + tremelimumab + azacitidine

Evaluate MEDI4736 in combination with tremelimumab and azacitidine

Group Type EXPERIMENTAL

VIDAZA

Intervention Type DRUG

VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy

tremelimumab

Intervention Type BIOLOGICAL

tremelimumab will be administered by IV infusion

Interventions

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MEDI4736 Evaluate MEDI4736 in MDS

MEDI4736 will be administered by IV infusion

Intervention Type BIOLOGICAL

VIDAZA

VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy

Intervention Type DRUG

tremelimumab

tremelimumab will be administered by IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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durvalumab azacitidine

Eligibility Criteria

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Inclusion Criteria

Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function.

Exclusion Criteria

Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior MAb against CTLA-4, PD-1, or PD-L1, alllogenic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MedImmune LLC

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

Scottsdale, Arizona, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

New Haven, Connecticut, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Atlanta, Georgia, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Rochester, Minnesota, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Greenville, South Carolina, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Research Site

Paris, , France

Site Status

Research Site

Dresden, , Germany

Site Status

Research Site

Brighton, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Countries

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United States France Germany United Kingdom

Other Identifiers

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D4190C00007

Identifier Type: -

Identifier Source: org_study_id

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