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The Knight SHIFT Study: Immunotherapy Timing for Advanced Solid Tumors

This study, called The Knight SHIFT Study, is looking at whether giving standard immune checkpoint inhibitor therapy in the morning versus the afternoon makes a difference for people with advanced or metastatic solid tumors. These are cancers that have spread from where they started. Researchers want to see if the body's natural daily rhythms (circadian rhythm) affect how well immunotherapy works. The study will compare how long people live without their cancer getting worse (progression-free survival) based on when they receive their treatment. It also looks at overall survival and side effects. You may be able to join if you are 18 or older and have certain advanced solid tumors like non-small cell lung cancer or head and neck squamous cell carcinoma. The study aims to enroll 160 participants, but its current status is unclear.

Study design
This is an interventional study where participants are randomly assigned to receive standard immune checkpoint inhibitor therapy either in the morning or in the afternoon. It plans to enroll 160 participants.
What's involved
You would receive standard of care immunotherapy for at least four doses and have blood samples collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured for up to two years from your last dose of immunotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07405086

Morning Versus Afternoon Administration of Immunotherapy for the Treatment of Advanced or Metastatic Solid Tumors, The Knight SHIFT Study

Recruiting
PHASE4Ages 18+InterventionalTreatment
OHSU Knight Cancer Institute
~160 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionImmune Checkpoint Inhibitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over 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])

Conditions

Advanced Biliary Tract Carcinoma
Advanced Head and Neck Squamous Cell Carcinoma
Advanced Hepatocellular Carcinoma
Advanced Lung Non-Small Cell Carcinoma
Advanced Malignant Solid Neoplasm
Advanced Melanoma
Advanced Renal Cell Carcinoma
Metastatic Biliary Tract Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hepatocellular Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Stage III Hepatocellular Carcinoma AJCC v8
Stage III Lung Cancer AJCC v8
Stage III Renal Cell Cancer AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8

Explore related trials

Biliary Tract CarcinomaHead and Neck Squamous Cell CarcinomaHepatocellular CarcinomaLung Non-Small Cell CarcinomaMelanomaRenal Cell CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Rajat Thawani · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Rajat Thawani
[email protected]
503-494-6574
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression free survivalFrom 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])

    The associated 95% confidence interval (CI) for each treatment group will be estimated using the Kaplan-Meier method. The stratified hazard ratio (HR) and its 95% CI will be estimated using a Cox proportional-hazard model with treatment group as the independent variable and stratified by the same randomization stratification factors as were used for the log-rank test.