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

StatusRecruiting
PhasePhase 4
Started

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Record History

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  1. Minor Start date: Jun 8, 2026 to Apr 24, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site contact updated
  2. Minor Start date changed from estimate of Jul 31, 2026 to Jun 8, 2026v4
  3. Notable Start date: May 5, 2026 to Jul 31, 2026v3
  4. Notable Phase changed: Phase 2 → Phase 4
    • Recruitment opened
    • Start date: Feb 20, 2026 to May 5, 2026
    • Site details revised
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
4,822 trials monitored
See 267 trials at risk
and 4 more diseases
This phase IV trial is evaluating whether morning versus afternoon administration of standard of care immunotherapy impacts its effectiveness in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Circadian rhythm refers to the internal biological clock in which various processes in the body, including immune cell activity, are controlled by the time of day. Exactly how this works is not fully understood, and the researchers want to see if circadian rhythm control of the immune system can influence response to immunotherapy based on whether it is given in the morning (before 10:30 am) or afternoon (12:30pm). The time of day that immunotherapy is given (morning versus afternoon) may impact the effectiveness in treating patients with advanced or metastatic solid tumors.
Trial Details
NCT Number NCT07405086
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University
Conditions
(from sponsor)
Advanced Biliary Tract Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hepatocellular Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, Advanced Renal Cell Carcinoma, Metastatic Biliary Tract Carcinoma +13 more
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Lung Neoplasms, Melanoma, Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov