Last updated on June 2020

QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients With Advanced Cancer


Brief description of study

This is a Phase IIb, single-arm, multicohort, open-label multicenter study of ALT-803 in combination with an FDA-approved PD-1/PD-L1 checkpoint inhibitor in patients with advanced cancers who have progressed following an initial response to treatment with PD-1/PD-L1 checkpoint inhibitor therapy. All patients will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus ALT-803 for up to 16 cycles. Each cycle is six weeks in duration. All patients will receive ALT-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug.

Clinical Study Identifier: NCT03228667

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Memorial Healcare System

Hollywood, FL United States
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Baptist Health - Lexington

Lexington, KY United States
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Henry Ford Hospital

Detroit, MI United States
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Mercy Research Joplin

Joplin, MO United States
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Cleveland Clinic - Main Site

Cleveland, OH United States
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Mercy Clinic Oklahoma City

Oklahoma City, OK United States
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Spartanburg Medical Center

Spartanburg, SC United States
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Sanford Clinical Research

Sioux Falls, SD United States
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Bon Secours Richmond

Richmond, VA United States
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University of Miami

Miami, FL United States
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University of Minnesota

Minneapolis, MN United States
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University of Rochester

Rochester, NY United States
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Genesis Cancer Center

Hot Springs, AR United States
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Horizon Oncology Associates

Lafayette, IN United States
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Baptist Health- Louisville

Louisville, KY United States
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MemorialCare Health System

Fountain Valley, CA United States
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Recruitment Status: Open


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