Neo-adjuvant Immunotherapy in Patients With Localized Melanoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat i więcej
- •Czerniak skóry lub błon śluzowych stadium III, możliwy do operacyjnego usunięcia
- •Pacjenci, którzy wcześniej otrzymywali niektóre leki immunologiczne mogą się kwalifikować, jeśli przerwali leczenie co najmniej 6 miesięcy temu
- •Pacjenci, którzy otrzymywali terapię celowaną mogą się kwalifikować, jeśli przerwali leczenie co najmniej 3 miesiące temu
✗ Disqualifies
- •Przerzuty nowotworu do odległych części ciała
- •Czerniak oka (typ uveitis)
- •Uczulenie na ipilimumab, nivolumab lub składniki tych leków
- •Brak zmian nowotworowych możliwych do pomiaru
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
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
Trial contact
Priyanka DEVI-MARULKAR, PhD, MBA
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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