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Morning vs. afternoon: can timing boost cancer immunotherapy?

NCT ID NCT07405086

Disease control Sponsor: OHSU Knight Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether getting standard immunotherapy in the morning (before 11 am) or afternoon (after 12 pm) changes how well it fights advanced or metastatic solid tumors. Researchers think the body's internal clock (circadian rhythm) might affect immune activity. About 160 adults with several cancer types will be randomly assigned to morning or afternoon treatment, and the team will track how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
immune checkpoint inhibitor
What this could lead to
If timing matters, this could help doctors schedule immunotherapy to improve its effectiveness against several types of advanced cancer.
What could go wrong
This is an early-phase study on timing, not a new drug. The effect may be small or absent, and results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) (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 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 * Active, uncontrolled central nervous system (CNS) metastases

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Conditions

The condition(s) this trial relates to.

biliary tract cancer cancer cutaneous melanoma head and neck squamous cell carcinoma hepatocellular carcinoma lung cancer lung neoplasm melanoma metastatic malignant neoplasm metastatic melanoma Neoplasm Metastasis non-small cell lung carcinoma renal cell adenocarcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • OHSU Knight Cancer Institute

    RECRUITING

    Portland, Oregon, 97239, United States

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