Neo-adjuvant Immunotherapy in Patients With Localized Melanoma

Recruiting now · Phase 2

Conditions studied: Cutaneous Melanoma, Stage III, Mucosal Melanoma

In brief

The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints. Notably, IT injections of immune checkpoint blockade (ICB) have been shown to induce immune-mediated tumor responses both at the injected site and at distant, non-injected tumor sites. While surgery has traditionally been the preferred treatment for stage III and IV melanoma patients, neoadjuvant therapy with anti-CTLA-4 and anti-PD-1 agents has shown promising efficacy. In patients with localized melanoma, it is hypothesized that IT administration of ipilimumab (anti-CTLA-4 Ab) combined with nivolumab (anti-PD-1 Ab) will provide the most effective and safe treatment combination. The NEO-1 study is a proof-of-concept clinical trial designed as a sub-protocol of NEOREM master protocol (NCT07262489) to validate the intratumoral immunotherapy approach, aiming to maximize the dose/efficacy ratio of combined ipilimumab and nivolumab treatment while minimizing systemic adverse events. This is an academic, open-label, multicentric, phase II clinical trial evaluating the efficacy and safety of intratumoral injections of ipilimumab and nivolumab combination as neoadjuvant treatment in localized stage III resectable cutaneous or mucosal melanoma patients. Baseline and on-treatment PORTRAIT profiling, as described in the NEOREM Master Protocol (NCT07262489), will be performed using fresh blood and tumor samples. This profiling will reveal the immune status of patients and support biomarker-driven preselection for future trials.

Key facts

Study ID: NCT07230613
Run by: UNICANCER
People needed: 50
Starts: 2026-01-12
Expected to finish: 2033-12-01
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients ≥ 18 years old.
Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.
Patients who received anti-PD-1 and stopped treatment > 6 months prior to their inclusion in NEO-1 trial are eligible.
Patients who received target therapy and stopped treatment > 3 months prior to their inclusion in NEO-1 trial are eligible.

You may not qualify if…

Patients with clinically or radiologically detectable distant metastases.
Patients with uveal melanoma.
Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and/ ipilimumab.
Patients without pathological evaluable disease according to RECIST v1.1 criteria.

Where it is running

CHU de Bordeaux- Hôpital Saint-André — Bordeaux, France (enrolling)
Centre Léon Bérard — Lyon, France (enrolling)
Hospices Civils de Lyon (Hôpital Lyon Sud) — Lyon, France (enrolling)
AP-HM Marseille (Hôpital de la Timone) — Marseille, France (enrolling)
AP-HP- Hôpital Saint-Louis — Paris, France (enrolling)
Gustave Roussy — Villejuif, France (enrolling)

Full record on ClinicalTrials.gov

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