Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study

PRIMARY OBJECTIVE: I. To compare progression-free survival among participants receiving immunotherapy based on time of day (ToD) administration (early versus \[vs.\] late). SECONDARY OBJECTIVES: I. To compare overall survival among participants receiving immunotherapy based on ToD administration (am vs. pm). II. To compare rates of significant immune-related adverse events (irAEs) based on ToD administration (am vs. pm). EXPLORATORY OBJECTIVES: I. To compare objective responses among participants receiving immunotherapy based on ToD administration (am vs. pm). II. To compare disease control among participants receiving immunotherapy based on ToD administration (am vs. pm). III. To compare the duration of response among participants receiving immunotherapy based on ToD administration (am vs. pm). OUTLINE: Patients are randomized to 1 of 2 cohorts. AM COHORT: Patients receive standard of care immunotherapy before 10:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study. PM COHORT: Patients receive standard of care immunotherapy after 13:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study. After completion of immunotherapy treatment, patients are followed up every 6 months for 2 years.