Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 13, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- OHSU Knight Cancer Institute
- Interventions being studied
- Procedure: Biospecimen Collection; Drug: Immune Checkpoint Inhibitor
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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) (non-actionable genomic alteration, 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
- Gastroesophageal cancer, including esophageal cancer, gastroesophageal cancer, or gastric cancer
- 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
- 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
- Known Active, uncontrolled central nervous system (CNS) metastases
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- OHSU Knight Cancer InstitutePortland, Oregon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 13, 2026. Always confirm current availability with the study team.