Knight Cancer Institute Study of Histology-Agnostic Immunotherapy Timing for Advanced or Metastatic Solid Tumors - Knight SHIFT

What this Trial Is About

Researchers are studying whether the timing of immunotherapy—given in the morning versus the afternoon—affects how well it works for patients with advanced or metastatic solid tumors. These tumors may have spread from their original site to nearby tissues, lymph nodes, or distant parts of the body. The study focuses on how the body's internal biological clock, or circadian rhythm, might influence the immune system's response to immunotherapy treatments using monoclonal antibodies. Participants are randomly assigned to receive standard of care immunotherapy either before 10:30 AM (morning group) or after 1:30 PM (afternoon group). Each group receives four doses of immunotherapy unless the disease progresses or side effects become unacceptable, after which treatment timing follows standard care schedules. Blood samples are collected throughout the study to help researchers understand treatment effects. After completing immunotherapy, patients are followed every six months for two years to monitor their health. During the study, participants undergo regular assessments including blood tests to track immune responses and side effects. Researchers measure progression-free survival, overall survival, and immune-related adverse events up to two years after treatment. The goal is to compare how morning versus afternoon administration impacts these outcomes, helping to understand if timing affects immunotherapy effectiveness and safety in treating advanced or metastatic solid tumors.

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