Neoadjuvant intratumoral ipilimumab plus nivolumab for resectable stage III melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NEO-1 is a multicenter phase II proof-of-concept trial testing intratumoral (image-guided) injections of ipilimumab combined with nivolumab given before surgical resection in patients with resectable stage III cutaneous or mucosal melanoma. The approach aims to concentrate immune checkpoint blockade in the tumor to boost local and systemic anti-tumor immunity while reducing the systemic toxicity seen with full-dose intravenous combination therapy. Fresh blood and tumor samples are collected at baseline and during treatment for PORTRAIT profiling to characterize the tumor microenvironment and identify predictive biomarkers. Patients proceed to planned surgery after the neoadjuvant intratumoral treatment and safety and anti-tumor response are monitored throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Priyanka DEVI-MARULKAR, PhD, MBA
• Email: p-devi-marulkar@unicancer.fr
• Phone: +33(0)662536043

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.