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Could the time of day you get immunotherapy boost its power against melanoma?

NCT ID NCT07574047

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 1 time

Summary

This study looks at whether giving immunotherapy infusions in the morning improves outcomes for people with advanced melanoma. Researchers will compare morning versus afternoon/evening dosing in 108 participants. The goal is to see if aligning treatment with the body's natural immune rhythms can help patients live longer without their cancer growing.

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 inhibitors (nivolumab, pembrolizumab, ipilimumab)
What this could lead to
If timing matters, this could lead to a simple change in when immunotherapy is given, potentially improving survival without new drugs.
What could go wrong
This is a small, early-phase trial (108 people) testing a timing hypothesis, not a new treatment. Results may not confirm benefit or apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 108 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2032

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: * Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures. * Histologically confirmed unresectable cutaneous stage III or stage IV melanoma. Note: Participants with central nervous system (CNS) metastases are eligible. * Participants with a previously treated other malignancy are eligible, if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low. * Measurable or evaluable disease. * Age ≥ 18 years. * Patients deemed suitable for ICI therapy based on the local investigator's clinical assessment. * ECOG performance status 0-2. * Women of childbearing potential must use effective contraception , not be pregnant or lactating and agree not to become pregnant during trial treatment and until 5 months after the last dose of trial treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential. * Men agree not to donate sperm or to father a child during trial treatment and until 5 months after the last dose of trial treatment. Exclusion Criteria: * Prior treatment with any systemic anti-cancer therapy; with the exception of prior adjuvant anti-PD-1 or BRAF/MEK inhibitor therapy if the time from last dose to recurrence is more than 6 months. * Recent treatment (within 28 days prior to first dose) with any experimental drug. * Known history of allogeneic organ transplant. * Uveal or mucosal melanoma. * Receipt of live attenuated vaccine within 28 days prior to first dose. * Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information. * Known hypersensitivity to trial drug(s) or to any component of the trial drug(s). * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect participant compliance or place the participant at high risk from treatment-related complications.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011, Switzerland

  • Ente Ospedaliero Cantonale (EOC)

    Bellinzona, 6500, Switzerland

  • HFR Fribourg

    Fribourg, Canton of Fribourg, 1708, Switzerland

  • HOCH Health Ostschweiz - Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Hôpitaux Universitaires de Genève HUG

    Geneva, 1211, Switzerland

  • Inselspital, Bern

    Bern, 3010, Switzerland

  • Spital Thurgau (Kantonsspital Münserlingen und Frauenfeld)

    Münsterlingen, 8596, Switzerland

  • Universitätsspital Zürich USZ

    Zurich, 8091, Switzerland

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