Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study
2 other identifiers
interventional
160
1 country
1
Brief Summary
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 11:00 am) or afternoon (12:00pm). 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedStudy Start
First participant enrolled
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 12, 2026
February 1, 2026
2.9 years
February 4, 2026
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
The associated 95% confidence interval (CI) for each treatment group will be estimated using the Kaplan-Meier method. The stratified hazard ratio (HR) and its 95% CI will be estimated using a Cox proportional-hazard model with treatment group as the independent variable and stratified by the same randomization stratification factors as were used for the log-rank test.
From date of randomization to date of first progression or death (any cause), whichever occurs first (up to 2 years from date of last dose of standard-of-care immune checkpoint inhibitor [ICI])
Secondary Outcomes (2)
Overall survival (OS)
From date of randomization to date of death (any cause) up to 2 years from date of last dose of standard-of-care ICI
Incidence of immune related adverse event (irAE) related time to treatment discontinuation
From date of first dose of standard-of-care ICI to date of last dose of standard-of-care ICI (an average of 2 years).
Study Arms (2)
Treatment (AM cohort)
EXPERIMENTALPatients 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.
Treatment (PM cohort)
EXPERIMENTALPatients 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.
Interventions
Undergo blood sample collection
Receive immune checkpoint inhibitor therapy
Eligibility Criteria
You may qualify if:
- Must provide written informed consent before any study-specific procedures or interventions are performed
- Aged ≥ 18 years
- Histologically confirmed advanced/metastatic solid tumor as follows:
- Non small cell lung cancer (NSCLC) (driver-negative, immune checkpoint inhibitor \[ICI\]-eligible)
- Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (platinum-eligible),
- Renal cell carcinoma (RCC)
- Biliary-tract cancer (BTC)
- Hepatocellular carcinoma (HCC)
- Melanoma
- Planned to receive a Food and Drug Administration (FDA)-approved immune check point inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) regimen for the treatment of their malignancy
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
You may not qualify if:
- Prior ICI-based regimen for treatment of cancer
- Current or prior use of immunosuppressive medication within 28 days before planned standard-of-care immunotherapy infusion, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone (or equivalent corticosteroid)
- Uncontrolled autoimmune disease requiring immunosuppression
- Active, uncontrolled central nervous system (CNS) metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- Oregon Health and Science Universitycollaborator
Study Sites (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajat Thawani
OHSU Knight Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 12, 2026
Study Start
February 20, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 12, 2026
Record last verified: 2026-02