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Neo-adjuvant Immunotherapy in Patients With Localized Melanoma

RecruitingPhase 2Ages 18 Years - anyAllUNICANCER
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In plain words

What the trial is, and whether it could suit you

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 prov

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Ipilimumab (YervoyTM, 50 mg/10 mL solution)
  • Nivolumab (OpdivoTM, 40 mg/4mL solution)
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Where

6 sites
CHU de Bordeaux- Hôpital Saint-André
Bordeaux, France
Centre Léon Bérard
Lyon, France
Hospices Civils de Lyon (Hôpital Lyon Sud)
Lyon, France
AP-HM Marseille (Hôpital de la Timone)
Marseille, France
AP-HP- Hôpital Saint-Louis
Paris, France
Gustave Roussy
Villejuif, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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