Study inclusion and exclusion criteria
Inclusion Criteria | Exclusion Criteria | Arm assignments | |
≥18 years | Biotin supplement use | Intervention arm | sPD-L1 ≥1.7 ng/mL and available clinical capacity |
Histological melanoma progressing despite immune checkpoint inhibitor | Pregnant or nursing | ||
Measurable disease | Standard of care arm | sPD-L1 <1.7 ng/mL or unavailable clinical capacity | |
ECOG ≤3 | |||
Ability to consent |
Eligible patients for the study will be consenting adults with histologically confirmed melanoma receiving PD-(L)1 immunotherapy who are referred for stereotactic body radiation therapy. Patients who are receiving biotin supplements, pregnant or nursing are excluded. Patients with elevated sPD-L1 on registration will enter the intervention arm where clinical capacity is sufficient. Patients with low sPD-L1 or who enter the trial when clinical capacity is not available will enter the standard of care arm.
sPD-L1, soluble programmed death ligand 1.