Actively Recruiting
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Led by OHSU Knight Cancer Institute · Updated on 2026-05-05
160
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent before any study-specific procedures or interventions are performed
- Aged 65 18 years
- Histologically confirmed advanced or metastatic solid tumor including non small cell lung cancer (driver-negative, immune checkpoint inhibitor eligible), recurrent or metastatic head and neck squamous cell carcinoma (platinum-eligible), renal cell carcinoma, biliary-tract cancer, hepatocellular carcinoma, or melanoma
- Planned to receive FDA-approved immune checkpoint inhibitor regimen for treatment
- Measurable disease according to RECIST 1.1 criteria
You will not qualify if you...
- Prior immune checkpoint inhibitor-based regimen for cancer treatment
- Current or prior use of immunosuppressive medication within 28 days before planned immunotherapy infusion, except intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses not exceeding 10 mg/day prednisone (or equivalent)
- Uncontrolled autoimmune disease requiring immunosuppression
- Active, uncontrolled central nervous system metastases
AI-Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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