A Phase 1/2 Study to Evaluate MEDI4736

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT01693562

Run by

MedImmune LLC

People needed

1022

Starts

2012-09-05

Expected to finish

2020-02-28

Last updated by the study team

2021-05-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Research Site — Burbank, California, United States
• Research Site — Gilroy, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Whittier, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami Beach, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Saint Louis Park, Minnesota, United States
• Research Site — Billings, Montana, United States
• Research Site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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