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Can a simple blood test predict immunotherapy results for melanoma patients?

NCT ID NCT03348891

Knowledge-focused Sponsor: Institut Claudius Regaud Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study involved 60 people with advanced melanoma who were already scheduled to receive immunotherapy drugs. Researchers collected blood samples and, when possible, tumor samples before and during treatment to look for biological markers that might predict whether the treatment would work. The goal was to find clues that could help doctors choose the best therapy for each patient in the future.

What this could mean

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

What this could lead to
If successful, this could help doctors predict which melanoma patients will benefit from specific immunotherapy combinations.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear markers, and results may not change patient care directly.

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

60 people

The number who actually took part.

Started

Sep 2018

Finished

Nov 2021

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: 1. Age ≥18 years at the time of study entry. 2. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma. 3. Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone or nivolumab + ipilimumab) has been decided. 4. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented. 5. Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started). 6. ECOG Performance status 0-2. 7. Life expectancy of at least 3 months. 8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures and to comply with the study protocol. 9. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Patient pregnant, or breast-feeding. 2. Uveal melanoma. 3. Any condition contraindicated with sampling procedures required by the protocol. 4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. 5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection. 6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • CHRU Claude HURIEZ

    Lille, France

  • CHU Montpellier Saint-Eloi

    Montpellier, France

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31059, France

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