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New Shot-in-Tumor combo aims to beat melanoma before surgery

NCT ID NCT07230613

Disease control Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Updated 2 times

Summary

This phase 2 trial tests injecting two immunotherapy drugs (ipilimumab and nivolumab) directly into melanoma tumors before surgical removal. The goal is to shrink or eliminate the cancer while reducing the severe side effects that can occur when these drugs are given through a vein. About 50 adults with stage III melanoma that can be surgically removed will receive up to three injections over three weeks, then have surgery. Researchers will check if the tumor is gone or mostly gone after treatment.

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 (immunotherapy drugs)
What this could lead to
If successful, this approach could offer a safer, more effective way to shrink melanoma tumors before surgery, potentially reducing recurrence and avoiding harsh side effects.
What could go wrong
This is a small, early-phase trial (50 participants) testing a new injection method. The treatment may not work as hoped, could cause unexpected side effects, or delay surgery.

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 50 people

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

Started

Jan 2026

Expected to finish

Dec 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.

In addition to NEOREM Master Protocol inclusion and exclusion criteria, the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial: Inclusion Criteria: 1. Patients ≥ 18 years old. 2. Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma. 3. Patients who received anti-PD-1 and stopped treatment \> 6 months prior to their inclusion in NEO-1 trial are eligible. 4. Patients who received target therapy and stopped treatment \> 3 months prior to their inclusion in NEO-1 trial are eligible. Exclusion Criteria: 1. Patients with clinically or radiologically detectable distant metastases. 2. Patients with uveal melanoma. 3. Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and/ ipilimumab. 4. Patients without pathological evaluable disease according to RECIST v1.1 criteria.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma mucosal melanoma

As listed by the trial registrant

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

Cutaneous melanoma, stage III 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

    6 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

  • AP-HM Marseille (Hôpital de la Timone)

    RECRUITING

    Marseille, 13005, France

  • AP-HP- Hôpital Saint-Louis

    RECRUITING

    Paris, 75010, France

  • CHU de Bordeaux- Hôpital Saint-André

    RECRUITING

    Bordeaux, 33075, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hospices Civils de Lyon (Hôpital Lyon Sud)

    RECRUITING

    Lyon, 69495, France

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