QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy
brief summary
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with melanoma who have progressed on or after chemotherapy and anti-PD-1/PD-L1 therapy.
detailed description
Treatment will be administered in two phases. Subjects will continue treatment for up to 1 year or until they experience progressive disease (PD) or experience unacceptable toxicity (not correctable with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter phase 2 of the study. Subjects may remain on phase 2 of the study for up to 1 year. Treatment will continue in phase 2 until the subject experiences PD or unacceptable toxicity (not correctable with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both phases, is up to 2 years.
official title
NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed on or After Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Therapy