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

ConditionsAdvanced Biliary Tract CarcinomaAdvanced Head and Neck Squamous Cell CarcinomaAdvanced Hepatocellular CarcinomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Malignant Solid NeoplasmAdvanced MelanomaAdvanced Renal Cell CarcinomaMetastatic Biliary Tract CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hepatocellular CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Renal Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage III Lung Cancer AJCC v8Stage III Renal Cell Cancer AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Must provide written informed consent before any study-specific procedures or interventions are performed

Aged ≥ 18 years

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),

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Immune Checkpoint Inhibitor

    Drug

    Receive immune checkpoint inhibitor therapy

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Treatment (AM cohort)Experimental treatment 2 interventions
Group B: Treatment (PM cohort)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

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.

Time frame
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])

Secondary outcomes

1

Overall survival (OS)

The median duration of OS and the associated 95% CI for each treatment group will be estimated using the Kaplan-Meier method. The stratified 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.

Time frame
From date of randomization to date of death (any cause) up to 2 years from date of last dose of standard-of-care ICI
2

Incidence of immune related adverse event (irAE) related time to treatment discontinuation

Will be analyzed for all evaluable patients using a Kaplan-Meyer survival analysis. The number of events, percentiles for the time to discontinuation for irAE-related reasons (25%, 50% (median), and 75% percentiles), and the proportion of participants who discontinued standard-of-care for irAE-related reasons will be summarized by treatment group.

Time frame
From date of first dose of standard-of-care ICI to date of last dose of standard-of-care ICI (an average of 2 years).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Source ClinicalTrials.gov
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