Study Comparing Morning Versus Afternoon Immunotherapy Timing for Treating Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating whether the time of day when immunotherapy is given affects its effectiveness in treating patients with advanced or metastatic solid tumors. This phase IV trial explores if receiving immunotherapy in the morning before 1100 am versus in the afternoon after 1200 pm influences how well the treatment works, considering the bodys circadian rhythm and its impact on immune system activity. Participants are randomly assigned to one of two groups the AM cohort receives standard of care immune checkpoint inhibitor therapy before 1030 am for four doses if there is no disease progression or unacceptable toxicity, and the PM cohort receives the same therapy after 130 pm for four doses under similar conditions. After these initial doses, further immunotherapy may be given according to standard care schedules. Blood samples are collected throughout the study to monitor biological responses. Throughout the trial, participants undergo regular assessments including blood sample collection and monitoring for disease progression and immune-related side effects. After completing immunotherapy treatment, participants are followed every six months for two years to evaluate progression-free survival, overall survival, and immune-related adverse events. The study measures how timing of immunotherapy influences treatment response and disease control over this period.

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