QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor
in Patients With Advanced Cancer
What is the anti-tumor activity of ALT-803 in combination with a 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 inhibitors?
Basic Study Information
Purpose:Location: University of Rochester Medical Center
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.
Study Reference #: ILUN18059
Lead Researcher (Principal Investigator)
Deborah Mulford, MD
Study Contact InformationStudy Coordinator: Amy Jasek
Phone: (585) 273-1912
Additional Study Details
Trial Not Found
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