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Morning vs. afternoon: could the clock boost immunotherapy against melanoma?

NCT ID NCT07696715

Disease control Sponsor: Radboud University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This trial investigates whether giving standard combination immunotherapy (ipilimumab and nivolumab) in the early morning (before 10 AM) versus the afternoon (after 1 PM) improves tumor response in people with advanced melanoma. About 170 participants with metastatic or inoperable melanoma will be randomly assigned to one of the two timing schedules. The study aims to see if aligning treatment with the body's natural circadian rhythm can boost the immune system's ability to fight cancer.

What this could mean

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

Active substance
ipilimumab and nivolumab (combination immunotherapy)
What this could lead to
If timing matters, this could lead to a simple change in when immunotherapy is given, potentially improving outcomes for melanoma patients without new drugs.
What could go wrong
This is a relatively small, open-label trial, so results may not be definitive. The effect of timing might be small or absent, and individual patient factors could influence outcomes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 170 people

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

Started

Aug 2026

Expected to finish

Sep 2033

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: * Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease. * At least 18 years of age. * World Health Organization (WHO) Performance Status 0-1. * Measurable disease according to RECIST 1.1. * Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment. * Signed informed consent form Exclusion Criteria: * Uveal or mucosal melanoma (unknown primary melanoma is allowed). * Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted. * Use of adrenal replacement medications, e.g. hydrocortisone. * Use of melatonin agonists. * Prior systemic therapy for irresectable/metastatic melanoma (prior T-VEC is allowed) * Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago). * Use of investigational drugs.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma

How to take part

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

  1. The places running it

    5 sites. 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

  • Amsterdam UMC

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Antoni van Leeuwenhoek

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • ErasmusMC

    NOT_YET_RECRUITING

    Rotterdam, Netherlands

  • Leiden UMC

    NOT_YET_RECRUITING

    Leiden, Netherlands

  • Radboudumc

    RECRUITING

    Nijmegen, Netherlands

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