Breast Cancer Clinical Trial

A Phase 1/2 Study to Evaluate MEDI4736

Summary

This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

View Full Description

Full Description

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death ligand-1 (PD-L1)) will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity (IM), and antitumor activity of MEDI4736 in adult participants with solid tumors. A dose exploration cohort will look at the safety profile of Q4W dosing of MEDI4736.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 18 or older.
In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.
In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, participants must have failed, be intolerant to, be ineligible for, or have refused
Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
Adequate organ and marrow function.
Participants must have at least 1 measurable lesion.
Available archived tumor tissue sample.
Willingness to provide consent for biopsy sample (dose-expansion only)

Exclusion Criteria:

Any prior Grade ≥ 3 immune-mediated adverse event (imAE) while receiving immunotherapy
Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
Prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors.
Active or prior documented autoimmune disease within the past 2 years
History of primary immunodeficiency
History of organ transplant that requires use of immunosuppressives
Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
Other invasive malignancy within 2 years
Women who are pregnant or lactating
Uncontrolled intercurrent illness
Known history of tuberculosis
Known to be human immunodeficiency virus (HIV) positive
Known to be Hepatitis B or C positive (except HCC participants)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

1022

Study ID:

NCT01693562

Recruitment Status:

Completed

Sponsor:

MedImmune LLC

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There are 79 Locations for this study

See Locations Near You

Research Site
Scottsdale Arizona, 85258, United States
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Burbank California, 91505, United States
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Gilroy California, 95020, United States
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Los Angeles California, 90025, United States
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Los Angeles California, 90095, United States
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Orange California, 92868, United States
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Palo Alto California, 94304, United States
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San Francisco California, 94115, United States
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Whittier California, 90603, United States
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New Haven Connecticut, 06520, United States
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Washington District of Columbia, 20007, United States
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Jacksonville Florida, 32224, United States
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Miami Beach Florida, 33140, United States
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Tampa Florida, 33612, United States
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Athens Georgia, 30607, United States
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Augusta Georgia, 30912, United States
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Chicago Illinois, 60637, United States
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Baltimore Maryland, 21201, United States
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Baltimore Maryland, 21231, United States
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Boston Massachusetts, 02215, United States
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Ann Arbor Michigan, 48109, United States
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Detroit Michigan, 48201, United States
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Minneapolis Minnesota, 55407, United States
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Saint Louis Park Minnesota, 55416, United States
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Billings Montana, 59101, United States
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Las Vegas Nevada, 89169, United States
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Hackensack New Jersey, 07601, United States
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Paterson New Jersey, 07503, United States
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Bronx New York, 10461, United States
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New York New York, 10065, United States
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Chapel Hill North Carolina, 27599, United States
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Huntersville North Carolina, 28078, United States
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Cleveland Ohio, 44106, United States
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Columbus Ohio, 43210, United States
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Portland Oregon, 97213, United States
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Philadelphia Pennsylvania, 19107, United States
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Pittsburgh Pennsylvania, 15212, United States
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Greenville South Carolina, 29605, United States
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Nashville Tennessee, 37203, United States
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Dallas Texas, 75201, United States
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Houston Texas, 77030, United States
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Houston Texas, 77090, United States
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San Antonio Texas, 78229, United States
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Salt Lake City Utah, 84403, United States
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Blacksburg Virginia, 24060, United States
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Fairfax Virginia, 22031, United States
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Seattle Washington, 98104, United States
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Liege , B-400, Belgium
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Namur , 5000, Belgium
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H2X 3, Canada
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Paris Cedex 10 , 75475, France
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Villejuif Cedex , 94800, France
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Berlin , 12200, Germany
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Gauting , 82131, Germany
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Heidelberg , 69120, Germany
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Jena , 07747, Germany
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Minden , 32429, Germany
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Lecce , 73100, Italy
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Milano , 20132, Italy
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Siena , 53100, Italy
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Gwangju , 61469, Korea, Republic of
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Seo-Gu , 49241, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Tainan , 70403, Taiwan
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Taipei , 10002, Taiwan
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London , EC1A , United Kingdom
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London , SW2 6, United Kingdom
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London , W1G 6, United Kingdom
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Oxford , OX3 7, United Kingdom
Research Site
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

1022

Study ID:

NCT01693562

Recruitment Status:

Completed

Sponsor:


MedImmune LLC

How clear is this clinincal trial information?

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