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Advanced Biliary Tract CarcinomaPhase 4NCT07405086

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

A Phase 4 study testing Biospecimen Collection and Immune Checkpoint Inhibitor in people with Advanced Biliary Tract Carcinoma and Advanced Head and Neck Squamous Cell Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection and Immune Checkpoint Inhibitor
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
24 Apr 2026to 31 Dec 2028
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Rajat Thawani, 503-494-6574, thoracic-research@ohsu.edu

    Rajat Thawani

    Recruiting

Other trials in United States

About this study

Official title: Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare progression-free survival among participants receiving immunotherapy based on time of day (ToD) administration (early versus [vs.] late).

SECONDARY OBJECTIVES:

  1. To compare overall survival among participants receiving immunotherapy based on ToD administration (am vs. pm).

II. To compare rates of significant immune-related adverse events (irAEs) based on ToD administration (am vs. pm).

EXPLORATORY OBJECTIVES:

  1. To compare objective responses among participants receiving immunotherapy based on ToD administration (am vs. pm).

II. To compare disease control among participants receiving immunotherapy based on ToD administration (am vs. pm).

III. To compare the duration of response among participants receiving immunotherapy based on ToD administration (am vs. pm).

OUTLINE: Patients are randomized to 1 of 2 cohorts.

AM COHORT: Patients receive standard of care immunotherapy before 10:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.

PM COHORT: Patients receive standard of care immunotherapy after 13:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.

After completion of immunotherapy treatment, patients are followed up every 6 months for 2 years.

Being tested
Biospecimen Collection, Immune Checkpoint Inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Melanoma, Carcinoma, Renal Cell, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Immune Checkpoint InhibitorDrug

    Also called ICI

    Receive immune checkpoint inhibitor therapy

Study groups in NCT07405086
Study groupRoleWhat they receive
Treatment (AM cohort)ExperimentalPatients receive standard of care immunotherapy before 10:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Immune Checkpoint Inhibitor
Treatment (PM cohort)ExperimentalPatients receive standard of care immunotherapy after 13:30 for 4 doses in the absence of disease progression or unacceptable toxicity. Subsequent doses may be given per standard of care timing. Patients also undergo blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Drug: Immune Checkpoint Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (2)

  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.

    Measured: 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start24 Apr 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07405086
Sponsor's protocol ID
STUDY00029305
Other IDs
NCI-2026-00433, STUDY00029305
Status last verified
Oct 2026
First submitted
4 Feb 2026
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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