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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.
• Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
Cohort 1 will enroll patients who have disease progression per RECIST v1.1 on or after single-agent checkpoint inhibitor therapy after experiencing an initial response (ie, confirmed CR or PR by RECIST V1.1) while taking checkpoint inhibitor therapy. Patients will be enrolled into distinct cohorts (1a-1k) based on cancer type.
Patients must have been treated with checkpoint inhibitor therapy after progressing on SoC therapy for their disease, as per FDA indication detailed below:
For cohort 4, patients with NSCLC, HNSCC, RCC, or urothelial carcinoma who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing SD by RECIST v1.1 for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy.
Sue Stanley, RN864firstname.lastname@example.org
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