Study ID: ImmunityBio CA-ALT-803-02-17 Quilt 3.055


QUILT-3.055: A Phase 2b, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination with a PD-1/PD-L1 Checkpoint Inhibitor in Patients Who Have Disease Progression Following an Initial Response to Treatment with PD-1/PD-L1 Checkpoint Inhibitor Therapy

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 patients 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.
Sioux Falls Region
Principal Investigator:
Christopher Sumey, MD
Solid Tumors, Bladder, Bronchioloalveolar , Colorectal, Gastric, Gastrointestinal, Other, Head and Neck, Lung, Melanoma, Merkel Cell, Non-Small Cell Lung Cancer, REN (Renal), Small Cell Lung Cancer, Urothelium
Phase IIB
Active - Open to Accrual