Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metasta… (NCT07405086) | Clinical Trial Compass
RecruitingPhase 4
Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
United States160 participantsStarted 2026-06-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether getting immunotherapy in the morning versus the afternoon actually changes how well it works — what does my doctor think about the biological idea behind this, and does it apply to the specific immunotherapy I'd be receiving?
2Since this is a Phase 4 trial, meaning the immunotherapy itself is already approved, does participating in this study change anything about the actual drugs I'd receive, or is the only difference the time of day my infusions are scheduled?
3The trial is measuring progression-free survival as its main outcome — how long might it take before there's any evidence about whether morning or afternoon timing makes a meaningful difference, and would I be committed to a specific infusion time throughout the whole course of treatment?
4Given my specific cancer type and stage, would my doctor consider this trial a reasonable fit, or would starting standard-of-care immunotherapy right away on my own schedule be a better path for my situation?
5If I enrolled and was assigned to a morning or afternoon infusion slot that doesn't fit well with my work, caregiving, or travel situation, is there any flexibility, and how would that affect my ability to stay in the trial long-term?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression free survival
Timeframe: 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])