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Morning vs. evening: can timing boost melanoma treatment?

NCT ID NCT07155317

Disease control Sponsor: Emory University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving standard immunotherapy drugs (ipilimumab and nivolumab) in the morning works better than giving them later in the day for people with advanced melanoma that has spread or cannot be removed. About 99 adults with stage IV melanoma will be randomly assigned to morning, afternoon, or evening treatment. The goal is to see if timing can improve how long the cancer stays under control and reduce side effects.

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 99 people

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

Started

Oct 2025

Expected to finish

Dec 2027

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: * Pathologically confirmed American Joint Committee on Cancer (AJCC) 8th edition stage IV unresectable cutaneous, acral, or mucosal melanoma * No uveal melanoma * Patients with asymptomatic, non-hemorrhagic brain metastases \< 2 cm are eligible * No prior immunotherapy within 1 year, (serine/threonine-protein kinase B-raf \[BRAF\]/mitogen-activated protein kinase \[MEK\] inhibitors allowed) * Eastern Cooperative Oncology Group (ECOG) 0-1 * Age ≥ 18 * Adequate organ function to receive ipilimumab/nivolumab Exclusion Criteria: * Immunosuppression (\> 10mg prednisone daily) * Active autoimmune disease that would preclude the administration of immunotherapy * Active leptomeningeal disease

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Conditions

The condition(s) this trial relates to.

acral lentiginous melanoma cutaneous melanoma melanoma metastatic melanoma mucosal melanoma

As listed by the trial registrant

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

Advanced acral melanoma Advanced cutaneous melanoma Advanced mucosal melanoma Clinical stage IV cutaneous melanoma ajcc V8 Metastatic acral melanoma Metastatic cutaneous melanoma Metastatic mucosal melanoma Unresectable acral melanoma Unresectable cutaneous melanoma Unresectable mucosal melanoma

How to take part

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

  1. The places running it

    2 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

  • Emory Saint Joseph's Hospital

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

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