A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

NCT ID: NCT02261220

Last Updated: 2020-03-06

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

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-13

Study Completion Date

2020-01-27

Brief Summary

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This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEDI4736 + Tremelimumab

Subjects with multiple tumor types.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type BIOLOGICAL

MEDI4736 is administered by IV infusion in combination with tremelimumab

tremelimumab

Intervention Type BIOLOGICAL

Tremelimumab is administered by IV infusion in combination with MEDI4736

Interventions

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MEDI4736

MEDI4736 is administered by IV infusion in combination with tremelimumab

Intervention Type BIOLOGICAL

tremelimumab

Tremelimumab is administered by IV infusion in combination with MEDI4736

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects
* 18 years and older
* Histologic confirmation of advanced solid tumors
* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.

Exclusion Criteria

* Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
* Active or prior documented autoimmune disease within the past 2 years
* Current or prior use of immunosuppressive medication within 14 days with some exceptions.
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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Scottsdale, Arizona, United States

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Duarte, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Whittier, California, United States

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Aurora, Colorado, United States

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New Haven, Connecticut, United States

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Miami Beach, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Ann Arbor, Michigan, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Fairfax, Virginia, United States

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Seattle, Washington, United States

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Angers, , France

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Besançon, , France

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Bordeaux, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Pierre-Bénite, , France

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Vandœuvre-lès-Nancy, , France

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Villejuif, , France

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Jena, , Germany

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Münster, , Germany

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Tübingen, , Germany

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Tel Aviv, , Israel

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Amsterdam, , Netherlands

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Amsterdam, , Netherlands

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Tilburg, , Netherlands

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Busan, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Gwangju, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Valencia, , Spain

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Glasgow, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Metropolitan Borough of Wirral, , United Kingdom

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Middlesbrough, , United Kingdom

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Oxford, , United Kingdom

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Countries

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United States Canada France Germany Israel Netherlands South Korea Spain United Kingdom

References

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Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

Reference Type DERIVED
PMID: 32816849 (View on PubMed)

Other Identifiers

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D4190C00010

Identifier Type: -

Identifier Source: org_study_id

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