NCT07405086RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- Apr 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- OHSU Knight Cancer Institute
- NCT number
- NCT07405086
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 160
- From Apr 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Uncontrolled autoimmune disease requiring immunosuppression
Other
- Known Active, uncontrolled central nervous system (CNS) metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OHSU Knight Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.