Table 1

Study inclusion and exclusion criteria

Inclusion CriteriaExclusion CriteriaArm assignments
≥18 yearsBiotin supplement useIntervention armsPD-L1 ≥1.7 ng/mL and available clinical capacity
Histological melanoma progressing despite immune checkpoint inhibitorPregnant or nursing
Measurable diseaseStandard of care armsPD-L1 <1.7 ng/mL or unavailable clinical capacity
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.