NCT07405086 Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study
| NCT ID | NCT07405086 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Advanced Biliary Tract Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2026-04-24 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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) (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 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 * Known Active, uncontrolled central nervous system (CNS) metastases
Contact & Investigator
Rajat Thawani
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT07405086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Biliary Tract Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07405086 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07405086 currently recruiting?
Yes, NCT07405086 is actively recruiting participants. Visit ClinicalTrials.gov or contact OHSU Knight Cancer Institute to inquire about joining.
Where is the NCT07405086 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT07405086 clinical trial?
NCT07405086 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Rajat Thawani at OHSU Knight Cancer Institute. The trial plans to enroll 160 participants.